Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FM and MCE, FM and sham-MCE, MCE and sham-FM, Sham-MCE and sham-FM.
- Who it may be relevant to
- Registry conditions: Low Back Pain, Low Back Pain, Recurrent. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
Overview
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
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.
Interventions
- Other FM and MCE
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. - Other FM and sham-MCE
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises. - Other MCE and sham-FM
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. - Other Sham-MCE and sham-FM
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
Primary outcome measures
- Change in Patient Specific Functional Scale (PSFS) [Time frame: Baseline, 3, 6 and 12 months]
Secondary outcome measures (12)
- Change in Oswestry [Time frame: Baseline, 3, 6 and 12 months]
- Change in PROMIS [Time frame: Baseline, 3, 6 and 12 months]
- Change in Tampa Scale of Kinesiophobia [Time frame: Baseline, 3, 6 and 12 months]
- Change in Visual analogue Scale [Time frame: Baseline, 3, 6 and 12 months]
- Change in Linton Örebro [Time frame: Baseline, 3, 6 and 12 months]
- Change in Start back [Time frame: Baseline, 3, 6 and 12 months]
- Change in Movement control tests [Time frame: Change from baseline at 3 month]
- Change in Spinal mouse [Time frame: Change from baseline at 3 month]
- Change in Balance measured with computer [Time frame: Change from baseline at 3 month]
- Change in Mobility of the hips [Time frame: Change from baseline at 3 month]
- Change in Two-point discrimination [Time frame: Change from baseline at 3 month]
- Change in Lef-right discrimination [Time frame: Change from baseline at 3 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- University Hospital of Oulu — Oulu
Identifiers
NCT: NCT03270631 · FM&KCStudy