The relative effectiveness of full kinetic chain manipulative therapy and full kinetic chain rehabilitation in the treatment of osteoarthritis of the knee.
Brief Synopsis of the Research

Therefore in this study we aim to establish the effect of the KFC manipulative therapy alone, FKC rehabilitation alone and the combination of the two interventions on osteoarthritis of the knee.

This will be done by means of a quantitative randomised comparative clinical trial. 60 patients will have been diagnosed with osteoarthritis of the knee according to the inclusion and exclusion criteria, and will be randomly divided into 3 groups. The first group will receive 6 treatments using FKC manipulative therapy alone, the second will receive 6 treatments using FKC rehabilitation alone, and the third group will receive 6 treatments using FKC manipulative therapy combined with FKC rehabilitation. Subjective (Beck Depression Inventory, McMaster Overall Therapy Effectiveness Tool, Western Ontario and McMaster Universities Osteoarthritis Index and Berg Balance Scale) and objective (Inclinometer) measures will be taken at baseline, 1 week and 1 month follow up.

These results will be recorded and the data analysed using SPSS statistical package at a 95% confidence interval.

Section B:

To be typed in Arial 12-point font in one and half line spacing (expand sections to fit contents, but keep within the specified maximum lengths)

1. Field of Research and Provisional Title

The relative effectiveness of full kinetic chain manipulative therapy and rehabilitation in the treatment of osteoarthritis of the knee.

2. Context of the Research

1. Osteoarthritis is a very common condition, affects 9.6% of men and 18% of women aged >60 years worldwide (Woolf and Pfleger, 2003).

2. Although multi-factorial, falls cause nearly two-thirds of all non-intentional injury related deaths in older adults (Hawk et al., 2006). One of the causative factors is loss of hip and knee proprioception secondary to increased joint degeneration, thus by addressing these problems with the rehabilitation and/or adjustment there may be a decreased risk of fall.

3. There is research to suggest that applying manipulative therapy and rehabilitation to the full kinetic chain yields greater benefits for KOA patients than at home rehabilitation alone (Deyle et al., 2005), however this combination of treatments has never been compared against full kinetic chain manipulative therapy alone.

4. KOA stiffness, pain and dysfunction was shown by Deyle et al., (2000) and Deyle et al., (2005) to improve better when adding manipulative therapy to a rehabilitation program as compared to placebo and exercise alone, respectively.

3. Research Problem and Aims

Aim:

The relative effectiveness of full kinetic chain manipulative therapy and rehabilitation in the treatment of osteoarthritis of the knee.

Objectives:

i) To determine whether manipulative therapy alone is effective in the short term treatment of KOA in terms of subjective and objective measurements.

ii) To determine whether manipulative therapy alone is effective in the intermediate term treatment of KOA in terms of subjective and objective measurements.

iii) To determine whether rehabilitation alone is effective in the short term treatment of KOA in terms of subjective and objective measurements.

iv) To determine whether rehabilitation alone is effective in the intermediate term treatment of KOA in terms of subjective and objective measurements.

v) To determine whether manipulative therapy combined with rehabilitation is effective in the short term treatment of KOA in terms of subjective and objective measurements.

vi) To determine whether manipulative therapy combined with rehabilitation is effective in the intermediate term treatment of KOA in terms of subjective and objective measurements.

vii) To compare short term results and intermediate results, respectively.

viii) To determine whether manipulative therapy combined with rehabilitation is effective in decreasing the risk of fall according to the Berg Balance Scale.

ix) To determine whether rehabilitation alone is effective in decreasing the risk of fall according to the Berg Balance Scale.

x) To determine which treatment method is more effective in decreasing the risk of fall according to the Berg Balance Scale.

4. Literature review

Osteoarthritis is a chronic degenerative disorder with a complex aetiology (Felson, 2000). It is characterized by focal loss of articular cartilage within synovial joints, associated with hypertrophy of bone (osteophytes and subchondral bone sclerosis) and thickening of the capsule, resulting in alterations in biomechanical properties (Woolf and Pfleger, 2003). It is a very common joint disorder, affecting mostly those above the age of 60 and can occur in any joint but is most common in the hip; knee; and the joints of the hand, foot, and spine (Symmons, Mathers and Pfleger, 2003). As many as 40% of people over the age of 65 suffering symptoms associated with knee or hip OA (Zhang et al., 2008), resulting in OA becoming the fourth leading cause of disability in the years 2000 (Symmons, Mathers and Pfleger, 2003). Although no cure exists, a number of treatment options exist to provide symptomatic relief as well as improvement of joint function. Amongst these are non-pharmacological interventions, such as rehabilitation, manual therapies, acupuncture and electromodalities, as well as pharmacological measures such as oral medication and intra-articular injections. In severe cases, where nonsurgical interventions have failed, more invasive approaches may be needed (Scher and Pillinger, 2007).

McCarthy (2004) compared the effectiveness of an at home exercise program on its own or when supplemented with a class-based exercise program. There was found to be a greater improvement in WOMAC score in the class-based exercise group (20.6%) than the at home group (8.8%). These relatively modest effects may be owed to inability of exercise to address a number of factors that prevent patients from maximising results from their exercise program. Fitzgerald (2005) identified quadriceps inhibition or activation failure, obesity, passive knee laxity, knee misalignment, fear or physical activity and self-efficacy as examples of such factors. The necessity for additional interventions to address these factors therefore becomes apparent.

Tucker et al. (2003) compared the relative effectiveness of knee joint manipulation versus a non-steroidal anti-inflammatory drug (NSAID), and found manipulation to be just as effective as NSAID's in the treatment on KOA. Fish et al., (2008) had similar results when comparing the effectiveness of knee joint mobilisation against Topical Capsaicin Cream. Capsaicin has been previously demonstrated superior to placebo in many painful disorders including knee and general osteoarthritis. Pollard, Ward, Hoskins and Hardy (2008) applied a manipulative therapy protocol, consisting of soft tissue mobilisation and an impulse thrust to the symptomatic knee joint complex. This was found to have a statistically significant improvement in knee pain, mobility, crepitus and function when compared to the control group (interferential current set at zero). Pollard et al. (2008) also noted that knee treatment had a significant improvement in hip movement of those in the intervention group compared to the control group. This may be owing to the effect that treatment to a single joint may have on the full kinetic chain (hereafter FKC).

A number of studies have been conducted on various joints of the full kinetic chain of the lower extremity to determine their effect on the knee. Cliborne et al., (2004) aimed to determine the short-term effect of hip mobilization on pain and range of motion (ROM) measurement in patient with knee osteoarthritis (OA). It was demonstrated that the presence of hip pain and pain on squatting, restricted hip flexion and/or a positive scouring test predicts a better knee OA outcome. Currier et al., (2007) suggest that pain over the hip, groin or anterior thigh; limitations in passive knee flexion and internal rotation of the hip; as well as pain with hip distraction predicts a favourable short-term response to hip mobilizations. In fact it was found that, based on the presence of one variable, the probability of a successful response was 92% at 48-hour follow-up, which increased to 97% if 2 variables were present. Iverson et al., (2008) suggest that the strongest predictor of whether adjusting the lumbopelvic spine will decrease knee pain (in patellofemoral pain syndrome) is if there is a side-to-side difference in hip internal rotation greater than 14°. The presence of this variable increased the likelihood of a successful outcome from 45% to 80%. These studies collectively show that correcting the various dysfunctions within the kinetic chain will have a favourable effect on knee joint dysfunction. However, there has yet to be a study that seeks to improve knee osteoarthritis by treating all indicated joints in the full kinetic chain.

Few studies have looked at what effect combining manipulation and rehabilitation would have in the treatment of KOA. Deyle et al., (2000) applied manual therapy to the knee as well as to the lumber spine, hip and ankle as required. Additionally patients where given to knee exercise program to perform in the clinic on treatment days and at home. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores are used to detect changes in the patients perception of function and quality of life, specifically related to the disease process. In this study, there was a 55.8% improvement in the treatment group as compared to a 14.6% improvement in those patients receiving placebo (subtherapeutic ultrasound), thus proving the effectiveness of combining manipulation and rehabilitation. Using similar methodologies, Deyle et al., (2005) compared an at home versus in clinic physical therapy program. Those being treated in clinic received supervised exercise, manual therapy to the FKC and a home exercise program, while a second group received at home exercise only. Significant improvements where seen in both groups, however the clinic treatment group had an improvement in WOMAC scores of 52% and only a 26% improvement was seen in the home exercise group. The author attributed this difference between groups to the application of manual therapy to the full kinetic chain. However, the clinic group performed the exercises under supervision and where corrected where necessary while the home group were largely unsupervised and may have performed the exercises incorrectly as a result, thus decreasing the benefit such exercises would have. One should therefore not consider the difference in group performance to be solely due to the addition of manual therapy.

To date there is no study which compares the effect of manual therapy alone versus the above mentioned treatment combinations. Therefore there is a need for a study to determine whether FKC manual therapy combined with a standardised rehabilitation program is more effective than either intervention alone in the treatment of osteoarthritis of the knee.

5. Research Methodology

Design type:

Quantitative comparative clinical trial conducted at the Durban University of Technology Chiropractic Day Clinic (hereafter DUT CDC).

Advertising: [Appendix A]

Old age homes and retirement villages throughout the greater Durban region will be approached, as well as advertisements placed on notice boards of DUT, community halls, shopping centres and places of worship.

Sampling procedure:

A sample size of 60 (n=60) will be selected by means of convenience sampling (Brink, 2006). Those individuals responding to the advertisements will be screened and accepted based on the inclusion and exclusion criteria.

Telephonic interview:

Patients are required to contact the DUT CDC telephonically to determine whether they meet the requirements of the study. This will be determined by asking the patient the following questions;

* Are you between the ages of 38 and 80?

* Have you had knee pain for longer than 1 year?

* Do you have a history of trauma or surgery to the lumbar spine or lower limb?

* Are you able to stand and walk on your own, with minimal need and/or without significant dependence on canes and walkers?

* Do you suffer from a chronic medical condition that would require you to take regular medication?

* Would you be prepared to have radiographs taken of your lower limb?

If the patient meets the criteria for the study, a consultation will be made, at which they will be presented with a letter of information and informed consent form [Appendix B], which they will be required to sign. The following inclusion and exclusion criteria will be assess using a case history [Appendix C]; physical exam [Appendix D]; lumbar and pelvis [Appendix E]; hip [Appendix F]; knee[Appendix G] and; ankle and foot [Appendix H] regional examinations.

Inclusion Criteria:

A. Criteria, as developed by Altman (1991), requires a minimum of one of the first three clinical criteria below (#1, 2 or 3) for diagnosis of KOA (sensitivity 89 % and specificity 88%).

1. Knee pain and crepitus with active motion and morning stiffness ≤ 30 min (with age 38 ≤ 80 years of age).

2. Knee pain and crepitus with active motion and morning stiffness >30 minutes and bony enlargement (with age 38 ≤ 80 years of age).

3. Knee pain and no crepitus and bony enlargement (with age 38 ≤ 80 years of age).

B. The following 4 criteria are all required:

4. Knee pain of ≥ 1 year duration and able to stand and walk without severe varus/valgus deformity and/or severe instability (Kellgren and Lawrence, 1957).

5. Diagnosis of concurrent subluxation/or joint dysfunction (S/JD) complex:

a. Diagnosis of S/JD will be supported throughout using the PART(S) system.

6. A patient must have a score of ≥720 mm (≥30%) on the WOMAC scale to be included (Tubach et al., 2005).

7. No history of meniscal or other knee surgery in the past 6 months (Pollard et al., 2008).

8. A diary will be kept to monitor whether medication consumption is increased, decreased or stays the same.

Exclusion Criteria:

1. Significant visual disorders, severe vestibular disorders, neurological and peripheral sensory disorders which may be a contra-indication to exercise

2. History of knee or hip joint replacement, severe varus or valgus deformity, instability, fracture and severe osteoporosis, Rheumatoid arthritis, or frank avascular necrosis with or without moderate or severe deformity,

3. History of significant lumbar herniated disc injury with sequela,

4. Severe balance and proprioception problems (i.e. inability to stand with and/or without marked spinal or hip deformity)

5. Symptoms of moderate to severe osteoarthritis in both knees and/or hips:

- Note: both knees can be treated if there is KOA or joint dysfunction in the opposite knee and otherwise no other severe complications as noted above. However, only data collected from the worst knee will be used for the purpose of the study.

6. Long term chronicity combined with multiple treatment failure - especially multiple failure with previous physical treatment (≥ 3), with and/or long term severe pain, and/or a severely complicated or complex disorder (such as multiple co-morbidities combined with KOA such as a mix of: knee, hip and lumbosacral OA, and/or cardiovascular and/or auto-immune disease), or a severely disabled and/or a patient with severe and decreased functional ability and/or a severe clinical depression, may lead - on a case by case basis, to exclusion.

A basic guide for #6 to be used on a case by case basis:

I. Pain: The patient gives a history that can be interpreted as having stayed constantly or chronically at a high level of an estimated verbal analogue score (VAS) of ≥ 7 or WOMAC score of 1680-1920mm (70-80%) (out of a maximum worst score of 2400mm) for 3 to 5 years or longer.

II. Complicated or complex: 3 or more disorders at one time in the same patient (with KOA) as listed from #1-5 above.

III. Severely disabled: dependent on a cane, brace or walker 75 to 100% of the time when ambulating; severe cardiovascular disease; severe instability in the knee or other joints or possibly less than, or markedly less than half the normal ROM.

IV. Clinically depressed: determined by history and use the Beck Depression Inventory (BDI). The BDI has been validated for measuring depression in clinical and nonclinical settings (Beck et al., 1961).

Radiological analysis:

Although diagnosis of KOA will be made primarily through clinical examination, knee x-rays will be taken on patients who qualify and consent to participate in the clinical trial. The purpose is to determine the grade of osteoarthritic change (according to the Kellgren-Lawrence scale (reference)), to confirm suspicions of contra-indications to treatment, or to rule out a pathology outside of OA. Additionally, the subject's history and physical examination may indicate the need for lumbosacral/pelvic, hip, ankle and/or foot x-rays (see exclusion criteria below).

Procedure:

Time

Baseline

2 weeks

4 weeks

6 weeks

1 week F/U

1 month F/U

# Rx

-

2

2

2

-

-

Outcome measurement

WOMAC

ROM

BBS

BDI

-

-

-

WOMAC

OTE

ROM

BBS

BDI

WOMAC

OTE

ROM

BBS

BDI

Once accepted into the study, patients will be randomly allocated into 3 (three) groups using a randomised allocation chart (reference).

Interventions:

Group A will be treated with only manipulative therapy of the FKC.

Group B will be treated with only rehabilitation of the FKC.

Group C will be treated with manipulative therapy combined with rehabilitation of the FKC.

Manipulative therapy: [Appendix I]

FKC manipulative therapy (manipulative therapy to the knee, and any indicated axial or appendicular joint dysfunction, such as to the spine, hip, ankle, and foot) for KOA has been hypothesized as superior to localised manipulative therapy (Deyle et al., 2005). Treatment will focus on carefully restoring knee flexion and extension by lesser grades of mobilization as recommended by Deyle et al., (2005) and Fish et al., (2008), and patellar mobilization as per Pollard et al., (2008), along with careful high velocity low amplitude axial elongation of the knee joint as per Fish et al., (2008).

Additionally, manipulative therapy will be applied where needed to the full kinetic chain using other diversified techniques, such as HVLA manipulation or mobilization as outlined in Shafer and Faye (1990), and/or Peterson and Bergman (2002). Also, the hip technique, as outlined by Hoeksma et al., (2004) and the use of HVLA knee manipulation methods from Tucker et al., (2005) will also be utilized when indicated.

The particular joint dysfunction also known as the subluxation complex or manipulable lesion will be chosen based upon findings in the regional examinations.

Rehabilitation: [Appendix J]

Rehabilitative therapy will include exercises, focused soft tissue treatment and stretch to the knee and elsewhere along the full kinetic chain where needed based upon functional assessment (Deyle et al., 2005). Also included in rehabilitation will be patient advice, education and home exercise recommendations for managing their KOA.

The rehabilitation protocol will be standardised across groups B and C, with minor case by case variations.

Intervention frequency:

All patient will receive:

- 6 treatments in the first three (3) weeks (2x treatments/week).

- Training in a rehabilitation program, to be completed daily.

- Regular telephonic communication (every 1-2 weeks) following the completion of the 6th treatment.

All groups will be required to return to the clinic no more than one (1) week after the 6th treatment and at the one (1) month follow up to have readings taken.

Measurement Tools:

All data will be collected previsit 1, no more than 1 week after 6th treatment and at 1 month follow up, with the exception of OTE which will not be collected at previsit 1.

Subjective data will b obtained by means of;

- Beck Depression Inventory [Appendix K]

- The McMaster Overall Therapy Effectiveness (OTE) Tool [Appendix L] will be used to assess patient satisfaction and general improvement.

o The OTE is a valid and reliable questionnaire that allows the patient to classify the change in their health status: whether their KOA symptoms, or overall quality of life has improved, remained the same, or worsened since the last visit (Chan et al., 2006)

- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Appendix M] detects change in function and quality of life in patients suffering from KOA using multiple questions with the visual analogy scale (VAS).

o The WOMAC is valid and reliable for KOA, and has a long history of being broadly and frequently utilized to assess knee and hip OA, thus allowing comparison to a large number of studies and trials (Bellamy et al., 1988).

- Berg Balance Scale (BBS) questionnaire [Appendix N] is a predictor of fall risk and will be delivered if the one legged standing test is failed (Hawk et al., 2006)). KOA patients who are +'ve for the Berg Balance Scale (BBS) will be monitored as a subgroup (with a + OLST and BBS) at all clinic assessments

Objective data will be obtained by means of:

- Inclinometer [Appendix O] readings for knee flexion and extension only to evaluate the patients range of motion (ROM) (reference).

Statistics:

The latest version of SPSS will be used to analyse the data.

6. Plan of Research Activities

Provide a summarised work plan for each year of the project giving information for each research activity per year, under the following headings:

Activity

Timeframes (target dates for the duration of the project)

7. Structure of Dissertation / Thesis Chapters

1. Introduction

2. Review of the related literature

3. Subjects and methods

4. Results

5. Discussion

6. Recommendations and conclusions

7. References

8. Potential Outputs

§ Provide details on envisaged measurable outputs (e.g. publications, patents, students, etc.);

§ Expected national and/or international acclaim for the research and contribution of research outputs to building the knowledge base;

§ Exploitability of outputs, e.g. applicability to community development, improved products, processes, services in SA, region and/or continent;

§ Expected effects of research results.

9. Key References

Brink, H. 2006. Fundamentals of research methodologies for health care professional. 2nd edition. Juta and co. Cape Town.

Cliborne, A., Wainner, R., Rhon, D., Judd, C., Fee, T., Matekel, R., and Whiteman, J. 2004. Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization. Journal of Orthopaedic & Sports Physical Therapy, November; 34(11): 676-685.

Currier, L., Froehlich, P., Carow, S., McAndrew, R., Cliborne, A, Boyles, R., Mansfield, L., and Wainner, R. 2007. Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favourable short-term response to hip mobilization. Physical Therapy, September; 87(9): 1106-1119.

Deyle, G., Allison, S., Matekel, R., Ryder, M., Stang, J., Gohdes,D., Hutton, J., Henderson, N., and Garber, M. 2005. Physical Therapy Treatment Effectiveness for Osteoarthritis of the Knee: A Randomised Comparison of Supervised Clinical Exercise and Manual Therapy Procedures versus a Home Exercise Program. Physical Therapy, 85(12): 1301-1317.

Deyle, G., Henderson, N., Matekel, R., Ryder, M., Garber, M., and Allison, S. 2000. Effectiveness of Manual Physical Therapies and Exercise in Osteoarthritis of the Knee. Annals of Internal Medicine, 132(3): 173-181.

Felson, D. 2000.Osteoarthritis: New Insights Part 2: Treatment Approaches. In: National Iinstitute of Health Conference, Annals of Internal Medicine; 133: 726-737.

Hawk, C., Hyland, J.K., Rupert, R., Colonvega, M. and Hall, S. 2006. Assessment of balance and risk for falls in a sample of community-dwelling adults aged 65 and older. Chiropractic and Osteopathy, 14(3).

Haynes, S. and Gemmell, H. 2007. Topical treatments for osteoarthritis of the knee. Clinical Chiropractic; 10: 126-138.

Iverson. C., Sutlive, T., Crowell, M., Morrell, R., Perkins, M., Garber, M., Moore, J., and Wainner, R. 2008. Lumbopelvic manipulation for the treatment of patients with patellofemoral pain syndrome: development of a clinical prediction rule. Journal of Orthopaedic & Sports Physical Therapy, June; 38(6): 297-312.

McCarthy, C., Mills, P., Pullen, R., Roberts, C., Silman, A., and Oldman, J. 2004. Supplementing a home exercise programme with a class-based exercise programme is more effective than home exercise alone in the treatment of knee osteoarthritis. Rheumatology; 43: 880-886.

Pollard, H., Ward, G., Hoskins, W. and Hardy, K. 2008. The effect of a manual therapy knee protocol on osteoarthritic knee pain: a randomised controlled trial. Journal of the Canadian Chiropractic Association, December; 52(4): 229-242.

Symmons D, Mathers C, Pfleger B. 2003. Global burden of osteoarthritis in the year 2000 [online]. Geneva: World Health Organization. Available at: URL: http://www3.who.int/whosis/menu.cfm?path=evidence,burden,burden_gbd2000docs&language=english

Tucker, M., Brantingham, J., Myburg, C. 2003. Relative effectiveness of a non-steroidal anti-inflammatory medication (Meloxicam) versus manipulation in the treatment of osteo-arthritis of the knee. European Journal of Chiropractic, 50: 163-183.

Woolf, A.D. and Pfleger, B. 2003. Burden of major musculoskeletal conditions. Bulletin of the World Health Organization, 81 (9).

Zhang, W., Moskowitz, R. W., Nuki, G., Abramson, S., Altman, R. D., Arden, N., Bierma-Zeinstra, S., Brandt, K. D., Croft, P., Doherty, M., Dougados, M., Hochberg, M., Hunter, D. J., Kwoh, K., Lohmander, L. S. and Tugwell, P. 2008. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis and Cartilage, 16:137-162.

Appendix L

The McMaster Overall Therapy Effectiveness (OTE) Tool (for general improvement and patient satisfaction)

Patient No. Visit No. Page No. .

Overall Treatment Evaluation - KOA

We would like to find out if there are any changes in the way you have been feeling since treatment started: after 6 treatments, and also at the 1st week and 1st month follow ups.

Since treatment started, has there been any change in your ACTIVITY LIMITATION, SYMPTOMS AND/OR FEELINGS related to your knee osteoarthritis?

Please indicate if there has been any change by checking ONE of the three boxes below (Better/About the same/Worse):

Better About the Same Worse

⇓ ⇓

If you have checked ABOUT THE SAME,

⇓ Please stop here. ⇓

If you have checked the box If you have checked the box

BETTER: WORSE:

How much BETTER would you say How much WORSE would you say

your ACTIVITY LIMITATION, your ACTIVITY LIMITATION,

SYMPTOMS AND/OR FEELINGS SYMPTOMS AND/OR FEELINGS

have been since treatment started? Have been since treatment started?

Please choose ONE of the options Please choose ONE of the options

below: below:

Almost the same, hardly better at all Almost the same, hardly worse at all

A little better A little worse

Somewhat better Somewhat worse

Moderately better Moderately worse

A good deal better A good deal worse

A great deal better A great deal worse

A very great deal better A very great deal worse

Patient No. Visit No. Page No. .

Overall Treatment Effect - CHF, continued

Answer the following question whether or not you answered BETTER or WORSE and what your response was. Note if you have improved, the change will be important since you likely will be able to carry out your responsibilities with greater ease and comfort compared to before the study. If on the other hand you are worse, then you will have more difficulty carrying out your responsibilities; this will also be important for you as you have more difficulty with your activities.

Is this change (BETTER/WORSE) important to you in carrying out your daily activities?

Not important

Slightly important

Somewhat important

Moderately important

Important

Very important

Extremely important

THANKS FOR YOUR COOPERATION!

Description of scales and how they will be assessed:

* Pages one and two are graded separately.

* Page one is graded on a 15 point scale. Scored from +7 to -7

* If the answer to the first question is Better then you have a + integer

* If the answer to the first question is About the Same the score is 0

* If the answer to the first question is Worse then you have a - integer

* With a + or - integer, the answers below the better or worse response are numbered sequentially from top to bottom. Almost the same, hardly better is a 1 and A very great deal better is a 7.

* Page two is graded on a 7 point scale. Scored from 1 to 7

* The answers are numbered sequentially from top to bottom. Not important is a 1 and Extremely important is a 7

Later we will dichotomize the scores on page one between scores > 1 (improved) and < 0 (not improved).

Appendix M

The WOMAC - Western Ontario and McMaster Universities osteoarthritis index

KNEE OSTEOARTHRITIS

Name:_________________________________________________

Date:___/___/______DOB:___/___/_____

In Sections A, B and C questions will be asked in the following format and you should give your answers by putting a straight vertical (up-and-down) mark on the horizontal line.

Note:

1. If make a straight vertical (up-and-down) mark on the line, at the left-hand end of the line, i.e.

NO PAIN

EXTREME

PAIN

Then you are indicating that you have no pain.

Note:

2. If make a straight vertical (up-and-down) mark on the line, at the Right-hand end of the line, i.e.

NO PAIN

EXTREME

PAIN

Then you are indicating that you have extreme pain.

3. Please Note:

a) that the further to the right-hand end you place your straight vertical (up-and-down) mark on the line, the more pain you are experiencing

b) that the further to the left-hand end you place your straight vertical (up-and-down) mark on the line, the less pain you are experiencing

c) Please do not place your straight vertical (up-and-down) mark on the line outside the markers.

You will be asked to indicate on this type of scale the amount of pain, stiffness, or disability you are experiencing. Please remember the further you place your straight vertical (up-and-down) mark on the line to the right, the more pain, stiffness, or disability you are indicating that you experience.

Section A

Instructions to Patients

The following questions concern the amount of pain you are currently experiencing in your Knee. For each situation please enter the amount of pain recently experienced. (Please mark your answers with a straight vertical {up-and-down} mark on the line).

1. Walking on a flat surface

NO PAIN

EXTREME

PAIN

2. Going up or down stairs

NO PAIN

EXTREME

PAIN

3. At night while in bed

NO PAIN

EXTREME

PAIN

4. Sitting or lying

NO PAIN

EXTREME

PAIN

5. Standing upright

NO PAIN

EXTREME

PAIN

Section B

Instructions to Patients

The following questions concern the amount of joint stiffness (not pain) you are currently experiencing in your knee. Stiffness is a sensation of restriction or slowness in the case with which you move your joints. (Please mark your answers with a straight vertical {up-and-down} mark on the line).

1. How severe is your stiffness after first wakening in the morning?

NO STIFFNESS

EXTREME

STIFFNESS

2. How severe is your stiffness after sitting, lying or resting later in the day?

NO STIFFNESS

EXTREME

STIFFNESS

Question: What degree of difficulty do you have with:

1. Descending stairs.

NO DIFFICULTY

EXTREME

DIFFICULTY

2. Ascending stairs

NO DIFFICULTY

EXTREME

DIFFICULTY

3. Rising from sitting

NO DIFFICULTY

EXTREME

DIFFICULTY

4. Standing

NO DIFFICULTY

EXTREME

DIFFICULTY

5. Bending to floor

NO DIFFICULTY

EXTREME

DIFFICULTY

6. Walking on a flat surface

NO DIFFICULTY

EXTREME

DIFFICULTY

7. Getting in/out of car

NO DIFFICULTY

EXTREME

DIFFICULTY

8. Going shopping

NO DIFFICULTY

EXTREME

DIFFICULTY

9. Putting on socks/stockings

NO DIFFICULTY

EXTREME

DIFFICULTY

10. Rising from bed

NO DIFFICULTY

EXTREME

DIFFICULTY

11. Taking off socks/stockings

NO DIFFICULTY

EXTREME

DIFFICULTY

12. Lying in bed

NO DIFFICULTY

EXTREME

DIFFICULTY

13. Getting in/out of bath

NO DIFFICULTY

EXTREME

DIFFICULTY

14. Sitting

NO DIFFICULTY

EXTREME

DIFFICULTY

15. Getting on/off toilet

NO DIFFICULTY

EXTREME

DIFFICULTY

16. Heavy domestic duties

NO DIFFICULTY

EXTREME

DIFFICULTY

17. Light domestic duties

NO DIFFICULTY

EXTREME

DIFFICULTY

Below is a ten-centimeter line that begins with 0 and ends with 10. On this scale 0 stands for “no pain”. 10 stands for pain “as bad as it can be.”

The first scale is for your usual (daily or typical) level of knee pain.

The second scale is for your knee pain level when it is at its worst.

Please think about your usual knee pain. On the line below, make a straight vertical (up-and-down) mark on the line to show how you usually feel.

NO PAIN

WORST PAIN IMAGINABLE

Please think about your knee pain when it is at its worst. On the line below, make a straight vertical (up-and-down) mark on the line to show how you feel when you knee pain is at its worst.

NO PAIN

WORST PAIN IMAGINABLE

Appendix N

Berg Balance Scale

The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. The BBS has been evaluated in several reliability studies. A recent study of the BBS, which was completed in Finland, indicates that a change of eight (8) BBS points is required to reveal a genuine change in function between two assessments among older people who are dependent in ADL and living in residential care facilities.

Description:

14-item scale designed to measure balance of the older adult in a clinical setting.

Equipment needed: Ruler, two standard chairs (one with arm rests, one without),

footstool or step, stopwatch or wristwatch, 15 ft walkway

Completion:

Time: 15-20 minutes

Scoring: A five-point scale, ranging from 0-4. “0” indicates the lowest level of function and “4” the highest level of function. Total Score = 56

Interpretation: 41-56 = low fall risk

21-40 = medium fall risk

0 -20 = high fall risk

A change of 8 points is required to reveal a genuine change in function between 2 assessments.

BERG BALANCE SCALE

Name: __________________________________ Date: ___________________

Location: ________________________________ Rater: ___________________

ITEM DESCRIPTION SCORE (0-4)

1. Sitting to standing ________

2. Standing unsupported ________

3. Sitting unsupported ________

4. Standing to sitting ________

5. Transfers ________

6. Standing with eyes closed ________

7. Standing with feet together ________

8. Reaching forward with outstretched arm ________

9. Retrieving object from floor ________

10. Turning to look behind ________

11. Turning 360 degrees ________

12. Placing alternate foot on stool ________

13. Standing with one foot in front ________

14. Standing on one foot ________

Total ________

GENERAL INSTRUCTIONS

Please document each task and/or give instructions as written. When scoring, please record the lowest response category that applies for each item.

In most items, the subject is asked to maintain a given position for a specific time. Progressively more points are deducted if:

• The time or distance requirements are not met

• The subject's performance warrants supervision

• The subject touches an external support or receives assistance from the examiner

Subject should understand that they must maintain their balance while attempting the tasks. The choices of which leg to stand on or how far to reach are left to the subject. Poor judgment will adversely influence the performance and the scoring.

Equipment required for testing is a stopwatch or watch with a second hand, and a ruler or other indicator of 2, 5, and 10 inches. Chairs used during testing should be a reasonable height. Either a step or a stool of average step height may be used for item # 12.

1. SITTING TO STANDING

INSTRUCTIONS: Please stand up. Try not to use your hand for support.

( ) 4 able to stand without using hands and stabilize independently

( ) 3 able to stand independently using hands

( ) 2 able to stand using hands after several tries

( ) 1 needs minimal aid to stand or stabilize

( ) 0 needs moderate or maximal assist to stand

2. STANDING UNSUPPORTED

INSTRUCTIONS: Please stand for two minutes without holding on.

( ) 4 able to stand safely for 2 minutes

( ) 3 able to stand 2 minutes with supervision

( ) 2 able to stand 30 seconds unsupported

( ) 1 needs several tries to stand 30 seconds unsupported

( ) 0 unable to stand 30 seconds unsupported

If a subject is able to stand 2 minutes unsupported, score full points for sitting unsupported. Proceed to item #4.

3. SITTING WITH BACK UNSUPPORTED BUT FEET SUPPORTED ON FLOOR OR ON A STOOL

INSTRUCTIONS: Please sit with arms folded for 2 minutes.

( ) 4 able to sit safely and securely for 2 minutes

( ) 3 able to sit 2 minutes under supervision

( ) 2 able to able to sit 30 seconds

( ) 1 able to sit 10 seconds

( ) 0 unable to sit without support 10 seconds

4. STANDING TO SITTING

INSTRUCTIONS: Please sit down.

( ) 4 sits safely with minimal use of hands

( ) 3 controls descent by using hands

( ) 2 uses back of legs against chair to control descent

( ) 1 sits independently but has uncontrolled descent

( ) 0 needs assist to sit

5. TRANSFERS

INSTRUCTIONS: Arrange chair(s) for pivot transfer. Ask subject to transfer one way toward a seat with armrests and one way toward a seat without armrests. You may use two chairs (one with and one without armrests) or a bed and a chair.

( ) 4 able to transfer safely with minor use of hands

( ) 3 able to transfer safely definite need of hands

( ) 2 able to transfer with verbal cuing and/or supervision

( ) 1 needs one person to assist

( ) 0 needs two people to assist or supervise to be safe

6. STANDING UNSUPPORTED WITH EYES CLOSED

INSTRUCTIONS: Please close your eyes and stand still for 10 seconds.

( ) 4 able to stand 10 seconds safely

( ) 3 able to stand 10 seconds with supervision

( ) 2 able to stand 3 seconds

( ) 1 unable to keep eyes closed 3 seconds but stays safely

( ) 0 needs help to keep from falling

7. STANDING UNSUPPORTED WITH FEET TOGETHER

INSTRUCTIONS: Place your feet together and stand without holding on.

( ) 4 able to place feet together independently and stand 1 minute safely

( ) 3 able to place feet together independently and stand 1 minute with supervision

( ) 2 able to place feet together independently but unable to hold for 30 seconds

( ) 1 needs help to attain position but able to stand 15 seconds feet together

( ) 0 needs help to attain position and unable to hold for 15 seconds

8. REACHING FORWARD WITH OUTSTRETCHED ARM WHILE STANDING

INSTRUCTIONS: Lift arm to 90 degrees. Stretch out your fingers and reach forward as far as you can. (Examiner places a ruler at the end of fingertips when arm is at 90 degrees. Fingers should not touch the ruler while reaching forward. The recorded measure is the distance forward that the fingers reach while the subject is in the most forward lean position. When possible, ask subject to use both arms when reaching to avoid rotation of the trunk.)

( ) 4 can reach forward confidently 25 cm (10 inches)

( ) 3 can reach forward 12 cm (5 inches)

( ) 2 can reach forward 5 cm (2 inches)

( ) 1 reaches forward but needs supervision

( ) 0 loses balance while trying/requires external support

9. PICK UP OBJECT FROM THE FLOOR FROM A STANDING POSITION

INSTRUCTIONS: Pick up the shoe/slipper, which is in front of your feet.

( ) 4 able to pick up slipper safely and easily

( ) 3 able to pick up slipper but needs supervision

( ) 2 unable to pick up but reaches 2-5 cm (1-2 inches) from slipper and keeps balance independently

( ) 1 unable to pick up and needs supervision while trying

( ) 0 unable to try/needs assist to keep from losing balance or falling

10. TURNING TO LOOK BEHIND OVER LEFT AND RIGHT SHOULDERS WHILE STANDING

INSTRUCTIONS: Turn to look directly behind you over toward the left shoulder. Repeat to the right. (Examiner may pick an object to look at directly behind the subject to encourage a better twist turn.)

( ) 4 looks behind from both sides and weight shifts well

( ) 3 looks behind one side only other side shows less weight shift

( ) 2 turns sideways only but maintains balance

( ) 1 needs supervision when turning

( ) 0 needs assist to keep from losing balance or falling

11. TURN 360 DEGREES

INSTRUCTIONS: Turn completely around in a full circle. Pause. Then turn a full circle in the other direction.

( ) 4 able to turn 360 degrees safely in 4 seconds or less

( ) 3 able to turn 360 degrees safely one side only 4 seconds or less

( ) 2 able to turn 360 degrees safely but slowly

( ) 1 needs close supervision or verbal cuing

( ) 0 needs assistance while turning

12. PLACE ALTERNATE FOOT ON STEP OR STOOL WHILE STANDING UNSUPPORTED

INSTRUCTIONS: Place each foot alternately on the step/stool. Continue until each foot has touched the step/stool four times.

( ) 4 able to stand independently and safely and complete 8 steps in 20 seconds

( ) 3 able to stand independently and complete 8 steps in > 20 seconds

( ) 2 able to complete 4 steps without aid with supervision

( ) 1 able to complete > 2 steps needs minimal assist

( ) 0 needs assistance to keep from falling/unable to try

13. STANDING UNSUPPORTED ONE FOOT IN FRONT

INSTRUCTIONS: (DEMONSTRATE TO SUBJECT) Place one foot directly in front of the other. If you feel that you cannot place your foot directly in front, try to step far enough ahead that the heel of your forward foot is ahead of the toes of the other foot. (To score 3 points, the length of the step should exceed the length of the other foot and the width of the stance should approximate the subject's normal stride width.)

( ) 4 able to place foot tandem independently and hold 30 seconds

( ) 3 able to place foot ahead independently and hold 30 seconds

( ) 2 able to take small step independently and hold 30 seconds

( ) 1 needs help to step but can hold 15 seconds

( ) 0 loses balance while stepping or standing

14. STANDING ON ONE LEG

INSTRUCTIONS: Stand on one leg as long as you can without holding on.

( ) 4 able to lift leg independently and hold > 10 seconds

( ) 3 able to lift leg independently and hold 5-10 seconds

( ) 2 able to lift leg independently and hold L 3 seconds

( ) 1 tries to lift leg unable to hold 3 seconds but remains standing independently.

( ) 0 unable to try of needs assist to prevent fall

( ) TOTAL SCORE (Maximum = 56)

Section C: Ethics

Note: Ethics requirements are faculty specific. Kindly ensure that you are aware of and have complied with the relevant ethics requirements.

Tick as appropriate:

Humans

Organisations

Animals

Environment

Yes ü

No

Yes

No

Yes

No

Yes

No

Indicate Category (X)

1.

Exempt from Ethics and Biosafety Research Committee Review (straightforward research without ethical problems)

2.

Expedited review (minimal risk to humans, animals or environment)

3.

Full Ethics and Biosafety Research Committee review recommended (possible risk to humans, animals, environment, or a sensitive research area)

4.

Full Ethics and Biosafety Research Committee review required (risk to humans, animals, environment, or a sensitive research area)

Attach Addendums (if any)

ETHICAL ISSUES CHECKLIST FOR RESEARCH APPROVAL

To be completed by all people wishing to conduct research under the auspices of Durban University of Technology.

1. Use the Durban University of Technology's Research Ethics Policy and Guidelines to ensure that ethical issues have been identified and addressed in the most appropriate manner, before finalising and submitting your research proposal.

2. Please indicate [by an X as appropriate] which of the following ethical issues could impact on your research.

3. Please type the motivations/further explanations where required in the cell headed COMMENTS.

4. The highlighted response cells indicate those responses which are of particular interest to the Ethics Committee

NO.

QUESTION

YES

NO

N/A

DECEPTION

1.

Is deception of any kind to be used? and if so provide a motivation for acceptability.

O

COMMENTS:

NO.

QUESTION

YES

NO

N/A

2.

Will the research involve the use of no-treatment or placebo control conditions? If yes, explain how subject's interests will be protected.

O

COMMENTS

CONFIDENTIALITY

3.

Does the data collection process involve access to confidential personal data (including access to data for purposes other than this particular research project) without prior consent of subjects? If yes, motivate the necessity

O

COMMENTS

4.

Will the data be collected and disseminated in a manner that will ensure confidentiality of the data and the identity of the participants? Explain your answer

O

COMMENTS

5.

Will the materials obtained be stored and ultimately disposed of in a manner that will ensure confidentiality of the participants? If no, explain. If yes specify how long the confidential data will be retained after the study and how it will be disposed of.

O

COMMENTS

6.

Will the research involve access to data banks that are subject to privacy legislation? If yes, specify and explain the necessity.

COMMENTS

RECRUITMENT

7

Does recruitment involve direct personal approach from the researchers to the potential subjects? Explain the recruitment process

O

COMMENTS

8

Are participants linked to the researcher in a particular relationship, for example employees, students, family? If yes, specify how.

O

COMMENTS

9

If yes to 8, is there any pressure from researchers or others that might influence the potential subjects to enrol? Elaborate.

O

COMMENTS

10

Does recruitment involve the circulation/publication of an advertisement, circular, letter etc? Specify

O

COMMENTS:

advertisement

11

Will subjects receive any financial or other benefits as a result of participation? If yes, explain the nature of the reward, and safeguards

O

COMMENTS

12

Is the research targeting any particular ethnic or community group? If yes, motivate why it is necessary/acceptable. If you have not consulted a representative of this group, give a reason. In addition explain any consultative processes, identifying participants. Should consultation not take place, give a motivation.

COMMENTS

INFORMED CONSENT

13

Does the research fulfil the criteria for informed consent? [See guidelines]. If yes, no further answer is needed. If no, please specify how and why.

O

COMMENTS

14

Does consent need to be obtained from special and vulnerable groups (see guidelines). If yes, describe the nature of the group and the procedures used to obtain permission.

COMMENTS

15

Will a Subject Information Letter be provided and a written consent be obtained? If no, explain. If yes, attach copies to proposal. In the case of subjects who are not familiar with English (e.g it is a second language), explain what arrangements will be made to ensure comprehension of the Subject Information Letter, Informed Consent Form and other questionnaires/documents.

O

COMMENTS

16

Will results of the study be made available to those interested? If no, explain why. If yes, explain how

COMMENTS

RISKS TO SUBJECTS

17

Will participants be asked to perform any acts or make statements which might be expected to cause discomfort, compromise them, diminish self esteem or cause them to experience embarrassment or regret? If yes, explain.

O

COMMENTS

18

Might any aspect of your study reasonably be expected to place the participant at risk of criminal or civil liability? If yes, explain.

O

COMMENTS

19

Might any aspect of your study reasonably be expected to place the participant at risk of damage to their financial standing or social standing or employability? If yes, explain.

O

COMMENTS

20

Does the protocol require any physically invasive, or potentially harmful procedures [e.g. drug administration, needle insertion, rectal probe, pharyngeal foreign body, electrical or electromagnetic stimulation, etc?] If yes, please outline below the procedures and what safety precautions will be used.

O

COMMENTS

21

Will any treatment be used with potentially unpleasant or harmful side effects? If yes, explain the nature of the side-effects and how they will be minimised.

COMMENTS

22

Does the research involve any questions, stimuli, tasks, investigations or procedures which may be experienced by participants as stressful, anxiety producing, noxious, aversive or unpleasant during or after the research procedures? If yes, explain.

COMMENTS

23

Will any samples of body fluid or body tissues be required specifically for the research which would not be required in the case of ordinary treatment? If yes, explain and list such procedures and techniques.

COMMENTS

24

Are any drugs/devices to be administered? If yes, list any drugs/devices to be used and their approved status.

O

COMMENTS

GENETIC CONSIDERATIONS

25

Will participants be fingerprinted or DNA "fingerprinted"? If yes, motivate why necessary and state how such is to be managed and controlled.

O

COMMENTS

26

Does the project involve genetic research e.g. somatic cell gene therapy, DNA techniques etc? If yes, list the procedures involved

O

COMMENTS

BENEFITS

27

Is this research expected to benefit the subjects directly or indirectly? Explain any such benefits.

COMMENTS

28

Does the researcher expect to obtain any direct or indirect financial or other benefits from conducting the research? If yes, explain.

O

COMMENTS

SPONSORS: INTERESTS AND INDEMNITY

29

Will this research be undertaken on the behalf of or at the request of a pharmaceutical company, or other commercial entity or any other sponsor? If yes, identify the entity.

O

COMMENTS

30

If yes to 29, will that entity undertake in writing to abide by Durban University of Technology's Research Committees Research Ethics Policy and Guidelines? If yes, do not explain further. If no, explain.

O

COMMENTS

31

If yes to 30, will that entity undertake in writing to indemnify the institution and the researchers? If yes, do not explain further. If no, explain.

O

COMMENTS

32

Does permission need to be obtained in terms of the location of the study? If yes indicate how permission is to be obtained.

O

COMMENTS

33

Does the researcher have indemnity cover relating to research activities? If yes, specify. If no, explain why not.

COMMENTS

34

Does the researcher have any affiliation with, or financial involvement in, any organisation or entity with direct or indirect interests in the subject matter or materials of this research? If yes, specify.

O

COMMENTS

The undersigned declare that the above questions have been answered truthfully and accurately

STUDENT NAME------------------------------------------------

SIGNATURE---------------------------------------------- DATE------------------------------

SUPERVISOR NAME------------------------------------------

SIGNATURE--------------------------------------------- DATE------------------------------

Please initial alongside if the project is to be registered as secret

Guidelines for the Preparation of a Research Proposal

(To be read in conjunction with the Postgraduate Student Guidelines)

Please ensure that you have completed, in every respect, all of the following prior to submission of your Research Proposal. Students are advised to use the electronic version of the PG 4 form which is available from the DUT website or from the Faculty Officer.

Please complete ALL SECTIONS, using Arial 12-point font, one and half line spacing in MS Word. Where sections are not applicable please adapt the form accordingly.

1. Proof-read your hard copy, ensure correct referencing, edit rigorously and then submit to your Supervisor(s).

2. Number all pages and show correct author source references both in the text proper and in the References at the end using the Harvard referencing method (IEEE for Engineering students).

3. Complete the Ethics Section, the Work Plan and the Budget correctly in every respect and again engage in a thorough spell check prior to submission to your Supervisor/Co- Supervisor(s)/ Promoter/Co-Promoter(s).

4. Please note carefully the closing dates, as outlined in the Academic Calendar, contained in the Rule Book for Students, the registration dates as well the expected duration for the completion of the project.

5. It is imperative that you adhere to your specified guidelines for completion of your research and institutional/faculty deadlines as published on the DUT website.

Reviewer / Review Panel Chair


Title

Tel (W)

Tel (H)

Cell

Fax

e-Mail

Yes

No

Un-
clear

Recommendations

Signed: __________________________Date: _______________________

(Reviewer)

Signed: __________________________Date: _______________________

(HoD)

ETHICS CLEARANCE CERTIFICATE

Student Name

Student No

Ethics
Reference Number

Date of

FRC Approval

Qualification

Research Title:

In terms of the ethical considerations for the conduct of research in the Faculty of Health Sciences, Durban University of Technology, this proposal meets with Institutional requirements and confirms the following ethical obligations:

1. The researcher has read and understood the research ethics policy and procedures as endorsed by the Durban University of Technology, has sufficiently answered all questions pertaining to ethics in the DUT 186 and agrees to comply with them.

2. The researcher will report any serious adverse events pertaining to the research to the Faculty of Health Sciences Research Ethics Committee.

3. The researcher will submit any major additions or changes to the research proposal after approval has been granted to the Faculty of Health Sciences Research Committee for consideration.

4. The researcher, with the supervisor and co-researchers will take full responsibility in ensuring that the protocol is adhered to.

5. The following section must be completed if the research involves human participants:

YES

NO

N/A

v Provision has been made to obtain informed consent of the participants

v Potential psychological and physical risks have been considered and minimised

v Provision has been made to avoid undue intrusion with regard to participants and community

v Rights of participants will be safe-guarded in relation to:

- Measures for the protection of anonymity and the maintenance of Confidentiality.

- Access to research information and findings.

- Termination of involvement without compromise

- Misleading promises regarding benefits of the research