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| A pragmatic, single blind randomised controlled pilot study for professional kinesiology practice and back pain with initial feasibility study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN76057921 |
| Date ISRCTN assigned | 10/04/2008 |
| Local reference number(s) | N/A |
| Public title | A pragmatic, single blind randomised controlled pilot study for professional kinesiology practice and back pain with initial feasibility study |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Chronic and recurrent low back pain |
| Study hypothesis | Null hypothesis: Kinesiology for back pain, as assessed by a reduction of 2.5 points on the Roland Morris Disability Scale after five weeks of treatment is not different from control. |
| Design/methodology | A single blind, single centre, randomised controlled pilot study with initial feasibility study |
| Research ethics review | Ethical approval was granted by South West Surrey Local Regional Ethics Committee on the 6th August 2004 (ref: 04/Q1909/22). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. 18 - 65 years, male and female 2. Chronic or recurrent non-specific low back pain (lower ribs to gluteal folds) 3. Previous episode of pain at least three months previously (constitutes a recurrent problem) 4. Current pain for the last three weeks (excludes short lived occurrence) 5. Roland Morris Disability scale score of greater than or equal to four (constitutes a clinical problem) |
| Participants - exclusion criteria | 1. Under 18 years or over 65 (serious spinal pathology more likely) 2. Currently undergoing other treatment for back pain other than analgesics (other treatment may have carry-over effect) - six weeks washout required 3. Previous kinesiology (naivety required as a sham treatment is involved) 4. Serious spinal pathology or systemic illness (outside scope of study) 5. Psychosis or alcohol abuse (completion of forms, safety of practitioner) 6. Disability of limbs, inability to lie on or get on and off an examination couch (for purpose of muscle testing) 7. Weigh more than 15 stone (safety limit of examination table) 8. Litigation pending due to back pain or receiving disability allowance due to back pain (potential treatment resistance until monies received or stopped) 9. Previous spinal operation or waiting for same (outcome likely to be different). Facet joint injections are accepted because the spinal anatomy remains the same. |
| Patient information material | |
| Anticipated start date | 01/09/2007 |
| Anticipated end date | 31/01/2009 |
| Status of trial | Ongoing |
| Target number of participants | 150 |
| Interventions | 1. Real kinesiolology: five treatments - once a week for five weeks 2. Sham kinesiology: five treatments - once a week for five weeks 3. Waiting control: six-week wait then re-randomised to either real or sham kinesiology - five treatments, once a week for five weeks |
| Primary outcome measure(s) | Back pain disability measured on the Roland Morris Disability Scale, a 24 item tick questionnaire where a score of at least four points indicates a clinical problem suficient to measure change and a reduction of 2.5 after treatment indicates clinical change. Data collected at baseline, end of treatment and follow up. |
| Secondary outcome measure(s) | 1. 36-item short form health survey (SF-36): a global quality of life scale - 11 questions measuring physical function, role limitation, mental health, vitality, pain and general health, measured at baseline, end of treatment and follow up 2. Visual Analogue Scale (VAS) for pain (0 - 10) (0 = no pain, 10 = worst imaginable pain), measured at baseline, end of treatment and follow up 3. Patient Enablement Instrument (a measure of patient enablement): six questions asking how the patient feels about coping with life after the consultation - scored on a four-point scale, measured at end of treatment 4. Consultation and Relational Empathy (CARE) (a measure of empathy): 11 questions scored on a six-point scale - how did the patient feel the practitioner was at making them feel at ease, etc., measured at end of treatment 5. Measure Yourself Medical Outcome Profile (MYMOP) (a patient rating of their chosen symptoms) comprises four items, scored by the patient on a seven point scale. The first two items are for symptoms that the patient decides are most important to them and the other items relate to daily activities and general well-being, measured at baseline, end of treatment and follow up 6. Holistic Complementary and Alternative Medicine Questionnaire (HCAMQ) (a measure of beliefs about complementary medicine): 17 questions asking about the patients beliefs about health and treatment, measured at baseline, end of treatment and follow up 7. Credibility/expectancy questionnaire: six questions asking how much the patient believes the treatment will help their condition, measured at end of treatment |
| Sources of funding | Investigator initiated and funded (UK) |
| Sponsor name | The University of Southampton (UK) |
| Sponsor details | Aldermoor Health Centre Aldermoor Close Southampton United Kingdom SO16 5ST |
| Sponsor email | S.S.Hall@soton.ac.uk |
| Sponsor website | http://www.soton.ac.uk/ |
| Contact name | Prof George Lewith |
| Contact details | University of Southampton Aldermoor Health Centre Aldermoor Close Southampton United Kingdom SO16 5ST |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN76057921 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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