Movement control exercise for low back pain
| ISRCTN | ISRCTN80064281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80064281 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/07/2010
- Registration date
- 26/08/2010
- Last edited
- 17/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Jeannette Saner
Scientific
Scientific
School of Health Professions
Zurich University of Applied Sciences
Technikumstrasse 71
P.O. Box
Winterthur
CH-8401
Switzerland
| jeannette.saner@zhaw.ch |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Movement control exercise for low back pain: a randomised controlled trial |
| Study objectives | The aim of this study is to investigate the effect of two different exercise treatments on a selected subgroup of subacute/chronic nonspecific low back pain (LBP) patients. It has the following research questions: Question 1: Are movement control exercises more effective than general exercises in patients with chronic non-specific LBP and movement control impairment? Question 2: Is the improvement of movement control of the lumbar spine, assessed with standardised clinical tests, associated with the functional improvement and pain reduction? Question 3: Is outcome associated with physical or psychosocial factors assessed before treatment? |
| Ethics approval(s) | Swiss Ethics of Cantons Zurich, Aargau and Basel approved on the 25th May 2010 (ref: KEK-ZH-Nr. 2010-0034/5) |
| Health condition(s) or problem(s) studied | Non-specific low back pain |
| Intervention | Current interventions as of 20/12/2011 4 private practices more are involved in the recruitment and treatment phase, in total 7 private practices. In addition patients are also recruited by email announcement and subsequently treated by physiotherapy staff of the university. Intervention group: Specific individual exercise and treatment based on subjective and physical findings. The patients in the movement control group will participate in a training/treatment program aiming at improving movement control of the lumbar spine. Control group: All patients will carry out strengthening exercises of abdominal, back, gluteal and thigh muscles under surveillance of a physiotherapist:. Weights and resistance will be individually adapted according to the needs of the patient. The program will last 12 weeks in maximum. The patients will have one to two individual treatment sessions of half an hour weekly, between 9 - 18 treatment sessions in total. In both groups no more than 10 minutes of other therapies like massage or mobilisation are allowed. Each therapy is applied by a specially trained physiotherapist. Each therapist will treat at least 4 patients in the trial. Time-points of assessment are at baseline, after treatment phase, 6 and 12 months follow-up after inclusion. Data will be collected through video assessment (movement control tests), physical measures (range of motion, endurance and two point discrimination) pre and post treatment and questionnaires given or in a later phase sent out to the patients. All patients receive 3 individualised home-exercises and are encouraged to use them for the next year. Previous interventions Patients will be recruited in five physiotherapy departments of clinics and three private practices after referral to physiotherapy by their physicians. Intervention group: Specific individual exercise and treatment based on subjective and physical findings. The patients in the movement control group will participate in a training/treatment program aiming at improving movement control of the lumbar spine. Control group: All patients will carry out strengthening exercises of abdominal, back, gluteal and thigh muscles under surveillance of a physiotherapist:. Weights and resistance will be individually adapted according to the needs of the patient. The program will last 12 weeks in maximum. The patients will have one to two individual treatment sessions of half an hour weekly, between 9 - 18 treatment sessions in total. In both groups no more than 10 minutes of other therapies like massage or mobilisation are allowed. Each therapy is applied by a specially trained physiotherapist. Each therapist will treat at least 4 patients in the trial. Time-points of assessment are at baseline, after treatment phase, 6 and 12 months follow-up after inclusion. Data will be collected through video assessment (movement control tests), physical measures (range of motion, endurance and two point discrimination) pre and post treatment and questionnaires given or in a later phase sent out to the patients. All patients receive 3 individualised home-exercises and are encouraged to use them for the next year. |
| Intervention type | Other |
| Primary outcome measure | Change in patients' major complaints, is assessed with the Patient Specific Functional Scale, PSFS, at baseline, after treatment phase, with 6 and 12 months follow-up after inclusion. |
| Secondary outcome measures | 1. Low back pain specific disability will be assessed with the Roland and Morris disability questionnaire at baseline, after treatment phase, and 6 and 12 months following inclusion 2. Graded chronic pain scale assesses the grade of chronicity at baseline, after treatment phase, with 6 and 12 months follow-up after inclusion 3. Endurance of lumbar and abdominal muscles is assessed with static isometric tests pre- and post-treatment 4. Two-point-discrimination assesses local perception in the lumbar spine pre- and post-treatment 5. Usage of medication, health care as well as sick leave because of LBP at baseline, after treatment phase, and 6 and 12 months following inclusion Co-variates: We will record the following potential predictors for positive or negative outcomes: 6. Age (years), Height (m), Weight (kg), body mass index (BMI) 7. Disease characteristics: duration of the complaints, pain intensity, pain location 8. Movement control of the lumbar spine is assessed with the movement control test battery consisting of 6 tests 9. Medication: type, dose and duration in the last month 10. Fear avoidance beliefs questionnaire 11. The belief of patient of what would help him/her the most Cointerventions: 13. Activity level in general hours per week 14. Impression of home exercises done: yes, no, sometimes Adherence to the exercise program is assessed using a diary that is kept by the physical therapists. Adherence to a home exercise program is assessed post treatment by a questionnaire. |
| Overall study start date | 21/06/2010 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 106 |
| Key inclusion criteria | Current inclusion criteria as of 20/12/2011 1. Age 18 to 75 years, male and female 2. Non-acute non-specific LBP (greater than 6 weeks duration of symptoms) but not longer than 6 months of sick leave due to LBP 3. Two or more positive tests for impaired movement control 4. At least 5 points on Roland Morris Disability questionnaire 5. Back pain that is provoked or worsened by distinct movements, activities or postures as described as the typical clinical behaviour 6. Written informed consent Previous inclusion criteria 1. Age 18 to 65 years, male and female 2. Non-acute non-specific LBP (greater than 6 weeks duration of symptoms) but not longer than 6 months of sick leave due to LBP 3. Two or more positive tests for impaired movement control 4. At least 5 points on Roland Morris Disability questionnaire 5. Back pain that is provoked or worsened by distinct movements, activities or postures as described as the typical clinical behaviour 6. Written informed consent |
| Key exclusion criteria | 1. Specific LBP (Fractures, carcinoma, anomalies, nerve root affection with neurological signs e.g. sensibility or reflex loss, muscle weakness) 2. Less than 6 weeks post-surgery; all post spinal fusion surgery 3. Psychosocial risk factors controlled with Örebrö Musculoskeletal Pain Questionnaire (ÖMOQ) 4. Peripheral or central neurological disease 5. Contraindications for exercise, e.g. major cardiovascular problems or postural hypotension 6. Inability to understand the purpose of the study 7. Psychological or psychiatric problems 8. Chronic abuse of toxic substances such as drugs or alcohol 9. Use of neuroleptics, sedatives, anti-epileptics and anti-depressives |
| Date of first enrolment | 21/06/2010 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
School of Health Professions
Winterthur
CH-8401
Switzerland
CH-8401
Switzerland
Sponsor information
Institut of Physiotherapy (Switzerland)
Research organisation
Research organisation
Zurich University of Applied Sciences
School of Health Professions
Technikumstrasse 71
P.O. Box
Winterthur
CH-8401
Switzerland
| info.gesundheit@zhaw.ch | |
| Website | http://www.gesundheit.zhaw.ch |
"ROR" |
https://ror.org/05pmsvm27 |
Funders
Funder type
Research organisation
Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland) (ref: SNF 13DPD6_127240/1 of 2. Sept)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/09/2011 | Yes | No |
