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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 10.1186/ISRCTN48684087
ClinicalTrials.gov identifier
EudraCT number
Public 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
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
Acronym N/A
Serial number at source N/A
Study hypothesis Do patients within a sub-group of movement control dysfunction profit more through a specific individually tailored exercise program than through general exercise?
Lay summary 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?
The study ran from 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
Ethics approval Ethics Committee of Carea (Kymenlaakso Hospital District) Finland, 17/05/2010
Study design Randomised single-blind placebo-controlled cross-over study
Countries of recruitment Finland
Disease/condition/study domain Movement Control Dysfunction within recurrent sub-acute LBP
Participants - 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.
Participants - 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
Anticipated start date 01/10/2010
Anticipated end date 31/12/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 70
Interventions 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.
Primary outcome measure(s) Roland-Morris Disability Questionnaire measured at baseline, after the 3 months intervention and finally 12 months after the start.
Secondary outcome measure(s) 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.
Sources of funding 1. Kela The Social Insurance Institution of Finland (Finland)
2. Finnish Cultural Foundation (Finland)
Trial website
Publications 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22494776
Contact name Mr  Vesa  Lehtola
  Address Allintie 8
  City/town Kotka
  Zip/Postcode 48220
  Country Finland
  Tel +35 844 556 0865
  Email vesa.lehtola@omt.org
Sponsor Kela The Social Insurance Institution of Finland (Finland)
  Address Kela, PL 20
  City/town Helsinki
  Zip/Postcode 00232
  Country Finland
  Email tutkimus@kela.fi
  Sponsor website: http://www.kela.fi
Date applied 04/12/2011
Last edited 01/08/2014
Date ISRCTN assigned 18/01/2012
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