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.
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
The relative effectiveness of full kinetic chain manipulative therapy and rehabilitation in the treatment of osteoarthritis of the knee.
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
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.
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.
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.
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.
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).
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).
1 week F/U
1 month F/U
Once accepted into the study, patients will be randomly allocated into 3 (three) groups using a randomised allocation chart (reference).
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.
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.
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).
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:
Timeframes (target dates for the duration of the project)
7. Structure of Dissertation / Thesis Chapters
2. Review of the related literature
3. Subjects and methods
6. Recommendations and conclusions
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.
The McMaster Overall Therapy Effectiveness (OTE) Tool (for general improvement and patient satisfaction)
Patient No.€Œ€Œ€Œ€Œ 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
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
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.€Œ€Œ€Œ€Œ 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?
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).
The WOMAC – Western Ontario and McMaster Universities osteoarthritis index
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.
1. If make a straight vertical (up-and-down) mark on the line, at the left-hand end of the line, i.e.
Then you are indicating that you have no pain.
2. If make a straight vertical (up-and-down) mark on the line, at the Right-hand end of the line, i.e.
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, s
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