Movement control exercise for low back pain

ISRCTN	ISRCTN80064281
DOI	https://doi.org/10.1186/ISRCTN80064281
Protocol serial number	N/A
Sponsor	Institut of Physiotherapy (Switzerland)
Funder	Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland) (ref: SNF 13DPD6_127240/1 of 2. Sept)

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

School of Health Professions
Zurich University of Applied Sciences
Technikumstrasse 71
P.O. Box
Winterthur
CH-8401
Switzerland

Email	jeannette.saner@zhaw.ch

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes