Condition category
Musculoskeletal Diseases
Date applied
04/12/2011
Date assigned
18/01/2012
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.kela.fi

Funders

Funder type

Government

Funder name

Kela

Alternative name(s)

Kansaneläkelaitos

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

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22494776
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27005470

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

24/03/2016: Publication reference added.