Condition category
Musculoskeletal Diseases
Date applied
13/07/2010
Date assigned
26/08/2010
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jeannette Saner

ORCID ID

Contact details

School of Health Professions
Zurich University of Applied Sciences
Technikumstrasse 71
P.O. Box
Winterthur
CH-8401
Switzerland
jeannette.saner@zhaw.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Movement control exercise for low back pain: a randomised controlled trial

Acronym

Study hypothesis

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

Swiss Ethics of Cantons Zurich, Aargau and Basel approved on the 25th May 2010 (ref: KEK-ZH-Nr. 2010-0034/5)

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

21/06/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

106

Participant 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

Recruitment start date

21/06/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

School of Health Professions
Winterthur
CH-8401
Switzerland

Sponsor information

Organisation

Institut of Physiotherapy (Switzerland)

Sponsor details

Zurich University of Applied Sciences
School of Health Professions
Technikumstrasse 71
P.O. Box
Winterthur
CH-8401
Switzerland
info.gesundheit@zhaw.ch

Sponsor type

Research organisation

Website

http://www.gesundheit.zhaw.ch

Funders

Funder type

Research organisation

Funder name

Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland) (ref: SNF 13DPD6_127240/1 of 2. Sept)

Alternative name(s)

Schweizerische Nationalfonds, SNSF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21943318

Publication citations

  1. Results

    Saner J, Kool J, de Bie RA, Sieben JM, Luomajoki H, Movement control exercise versus general exercise to reduce disability in patients with low back pain and movement control impairment. A randomised controlled trial., BMC Musculoskelet Disord, 2011, 12, 207, doi: 10.1186/1471-2474-12-207.

Additional files

Editorial Notes