Efficacy of movement control exercises versus general exercises on recurrent sub-acute non-specific low back pain in a sub-group of patients with movement control dysfunction
| ISRCTN | ISRCTN48684087 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48684087 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/12/2011
- Registration date
- 18/01/2012
- Last edited
- 24/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Practice guidelines recommend various types of exercise for chronic back pain but there have been only a few head-to-head comparisons of these treatments. General exercise seem to be an effective treatment for chronic low back pain (LBP) but very little is known about the treatment of a sub-acute LBP within sub-groups. Clinical tests have been developed to identify a subgroup of patients with chronic non-specific LBP who have movement control dysfunction (MD). The aim of this study is to compare the effects of general exercise and specific movement control exercise (SMCE) on disability and function in patients with MD within recurrent sub-acute LBP.
Who can participate?
Patients aged between 16 and 65 years seeking treatment for sub-acute non-specific LBP from one physical therapy clinic in Kotka, Finland.
What does the study involve?
Participants will be randomly allocated to take part in either a movement control exercise program or a general exercise program. A physical therapist carries out an initial assessment of each participant allocated to the each exercise group to determine how physically active the participant is, how troublesome the back problem is, and the ability of the participant to perform the exercises. These are measured by the treating physiotherapist by asking the participant. Participants are then taught the exercises and advised regarding the intensity at which they should exercise. The exercises are performed under supervision of a physical therapist. The intensity of the exercises is progressed over the five treatments with participants being encouraged to improve their own performance. Each session lasts 45 minutes and includes a short session (10-15 minutes) of manual therapy.
What are the possible benefits and risks of participating?
The possible benefit to the participants is to learn a healthy way to cope with their low back problem. The possible risk to the participants is musculoskeletal pain after the exercises.
Where is the study run from?
University of Eastern Finland (Finland)
When is the study starting and how long is it expected to run for?
October 2010 to November 2012
Who is funding the study?
Kela The Social Insurance Institution of Finland and Finnish Cultural Foundation (Finland)
Who is the main contact?
Vesa Lehtola
vesa.lehtola@omt.org
Contact information
Scientific
Allintie 8
Kotka
48220
Finland
| Phone | +35 (0)844 556 0865 |
|---|---|
| vesa.lehtola@omt.org |
Study information
| Study design | Randomised single-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | GP practice |
| 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 | Efficacy of movement control exercises versus general exercises on recurrent sub-acute non-specific low back pain in a sub-group of patients with movement control dysfunction: protocol of a randomized controlled trial |
| Study objectives | Do patients within a sub-group of movement control dysfunction profit more through a specific individually tailored exercise program than through general exercise? |
| Ethics approval(s) | Ethics Committee of Carea (Kymenlaakso Hospital District) Finland, 17/05/2010 |
| Health condition(s) or problem(s) studied | Movement Control Dysfunction within recurrent sub-acute LBP |
| Intervention | There will be approximately 35 participants in each group (movement control exercises versus general exercises). A physical therapist carries out an initial assessment of each participant allocated to each exercise group to determine how physically active the participant is, how troublesome the back problem is, and the ability of the participant to perform the exercises. These are measured by the treating physiotherapist by asking the participant. Participants are then taught the exercises and advised regarding the intensity at which they should exercise. The exercises are performed under supervision of a physical therapist. The intensity of the exercises is progressed over the five treatments with participants being encouraged to improve their own performance. Each session lasts 45 minutes and includes a short session (10-15 minutes) of manual therapy. |
| Intervention type | Behavioural |
| Primary outcome measure | Roland-Morris Disability Questionnaire measured at baseline, after the 3 months intervention and finally 12 months after the start. |
| Secondary outcome measures | 1. Patient-Specific Functional and Pain Scale (PSFS) 2. Oswestry Disability Index 3. Movement control tests described by Luomajoki et al. 4. The amount of absence from work with a questionnaire 5. The need for other treatment modalities with a questionnaire 6. The need for pain medication with a questionnaire 7. Patient satisfaction with global assessment with a questionnaire Measured at baseline, after the 3 months intervention and finally 12 months after the start. |
| Overall study start date | 01/10/2010 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Key inclusion criteria | 1. The aim of the 'rest' inclusion regimen is to sub-classify those patients who have movement dysfunction (MD). The inclusion criteria involves three questionnaires and physical examination. Within the results of the questionnaires the participant should score: 1.1. Roland-Morris Disability Questionnaire to be > 5 points 1.2. DEPS < 12 points, Tampa Scale for Kinesiophobia < 38 points 1.3. Motor Control Abilities Questionnaire < 80 points The Motor Control Abilities Questionnaire (MCAQ) is a self-report tool that was developed to screen people for their ability to learn specific motor control stability exercise and specific movement control exercise. Reliability and validity have been established. A cut-off point of 80 has a specificity of 0.98 and a sensitivity of 0.88. The MCAQ should be used to exclude those subjects who are unable to learn the exercises and thus not benefit from the treatment. 2. Within the physical examination the participant should have > 2/6 positive movement control dysfunction test described by Luomajoki et al and not to have Straight Leg Raise (SLR) under 50 degrees positive or any positive sacroiliac-joint pain provocation tests to be eligible to participate in the study. Clinical assessment should indicate that the subject is suitable for active exercise, which is asked within a questionnaire. |
| Key exclusion criteria | 1. Neurological signs (leg weakness) 2. Specific spinal pathology (e.g. malignancy, or inflammatory joint or bone disease) 3. Have undergone back surgery 4. The aim of the measurement of DEPS, TSK and MCAQ is to rule out those patients with LBP of non-mechanical origin, e.g. depression, fear-avoidance and a poor ability to learn exercises 5. The aim of physical examination of SLR and sacroiliac-joint provocation tests is to rule out those patients with mechanical movement impairment |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Finland
Study participating centre
48220
Finland
Sponsor information
Government
Kela, PL 20
Helsinki
00232
Finland
| tutkimus@kela.fi | |
| Website | http://www.kela.fi |
"ROR" |
https://ror.org/057yw0190 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Social Insurance Institution of Finland, Kansaneläkelaitos
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Cultural Foundation, SKR
- Location
- Finland
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/04/2012 | Yes | No | |
| Results article | results | 22/03/2016 | Yes | No |
Editorial Notes
24/03/2016: Publication reference added.
