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 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 trial start date
21/06/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
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
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)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNSF, FNS, SNF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21943318
Publication citations
-
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.