Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Study Overview
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Brief Summary
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Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

Detailed Description
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Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

Official Title
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Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT

Conditions
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Low Back Pain, Low Back Pain, Recurrent

Intervention / Treatment
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* Other: FM and MCE
* Other: FM and sham-MCE
* Other: MCE and sham-FM
* Other: Sham-MCE and sham-FM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu. Exclusion Criteria: Specific low back pain cause and earlier fascial manipulation treatment given.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Five groups: 1) control, 2) fascial manipulation (FM) + movement control exercise (MCE), 3) FM + sham-MCE, 4) MCE + sham-FM and 5) sham-FM and sham-MCE
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Multidisciplinary rehabilitation, no interventions | |
| Experimental: FM and MCE<br>Subjects will have 4-5 times of fascial manipulation (FM) treatment and 4-6 times movement control exercises (MCE) at home to be done based on movement control testing (MCT). Both are given in 3 month period. | Other: FM and MCE<br>* Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.<br>|
| Other: FM and sham-MCE<br>FM 4-5 times in 3 months and 4 general exercise prescription. | Other: FM and sham-MCE<br>* Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.<br>|
| Other: MCE and sham-FM<br>Sham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises. | Other: MCE and sham-FM<br>* Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized.<br>|
| Sham Comparator: Sham-MCE and sham-FM<br>4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points. | Other: Sham-MCE and sham-FM<br>* Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Specific Functional Scale (PSFS) | Three different meaningful tasks will be rated from 0 to 10 as how hard is the task. | Baseline, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry | Disability index | Baseline, 3, 6 and 12 months | 
| Change in PROMIS | Quality of life | Baseline, 3, 6 and 12 months | 
| Change in Tampa Scale of Kinesiophobia | Fear of movement | Baseline, 3, 6 and 12 months | 
| Change in Visual analogue Scale | Pain scale | Baseline, 3, 6 and 12 months | 
| Change in Linton Örebro | Psychosocial risk factor | Baseline, 3, 6 and 12 months | 
| Change in Start back | Screening tool of the psychosocial risk factors | Baseline, 3, 6 and 12 months | 
| Change in Movement control tests | Clinical tests for LBP | Change from baseline at 3 month | 
| Change in Spinal mouse | Mobility of the spine | Change from baseline at 3 month | 
| Change in Balance measured with computer | Power plate | Change from baseline at 3 month | 
| Change in Mobility of the hips | Hip ROM | Change from baseline at 3 month | 
| Change in Two-point discrimination | How far apart subject is able to feel two distinctive point of touch | Change from baseline at 3 month | 
| Change in Lef-right discrimination | How subject is able to understand right and left of the back | Change from baseline at 3 month | 
| Change in Ultrasound of the fascia | Several fascial structures are measured | Change from baseline at 3 month |