Plain English 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?
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Vesa Lehtola
ORCID ID
Contact details
Allintie 8
Kotka
48220
Finland
+35 (0)844 556 0865
vesa.lehtola@omt.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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?
Ethics approval
Ethics Committee of Carea (Kymenlaakso Hospital District) Finland, 17/05/2010
Study design
Randomised single-blind placebo-controlled cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/10/2010
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant 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
Recruitment start date
01/10/2010
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Finland
Trial participating centre
Allintie 8
Kotka
48220
Finland
Sponsor information
Organisation
Kela The Social Insurance Institution of Finland (Finland)
Sponsor details
Kela
PL 20
Helsinki
00232
Finland
-
tutkimus@kela.fi
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Kela
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
Finland
Funder name
Finnish Cultural Foundation (Finland)
Alternative name(s)
Finnish Cultural Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Finland
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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22494776
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27005470
Publication citations
-
Protocol
Lehtola V, Luomajoki H, Leinonen V, Gibbons S, Airaksinen O, Efficacy of movement control exercises versus general exercises on recurrent sub-acute nonspecific low back pain in a sub-group of patients with movement control dysfunction. Protocol of a randomized controlled trial., BMC Musculoskelet Disord, 2012, 13, 55, doi: 10.1186/1471-2474-13-55.
-
Results
Lehtola V, Luomajoki H, Leinonen V, Gibbons S, Airaksinen O, Sub-classification based specific movement control exercises are superior to general exercise in sub-acute low back pain when both are combined with manual therapy: A randomized controlled trial, BMC Musculoskelet Disord, 2016, 17, 1, 135, doi: 10.1186/s12891-016-0986-y.