Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
- Conditions
- Low Back PainLow Back Pain, Recurrent
- Registration Number
- NCT03270631
- Lead Sponsor
- Oulu University Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 250
- Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.
- Specific low back pain cause and earlier fascial manipulation treatment given.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Patient Specific Functional Scale (PSFS) Baseline, 3, 6 and 12 months Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
- Secondary Outcome Measures
Name Time Method Change in PROMIS Baseline, 3, 6 and 12 months Quality of life
Change in Mobility of the hips Change from baseline at 3 month Hip ROM
Change in Lef-right discrimination Change from baseline at 3 month How subject is able to understand right and left of the back
Change in Ultrasound of the fascia Change from baseline at 3 month Several fascial structures are measured
Change in Tampa Scale of Kinesiophobia Baseline, 3, 6 and 12 months Fear of movement
Change in Visual analogue Scale Baseline, 3, 6 and 12 months Pain scale
Change in Linton Örebro Baseline, 3, 6 and 12 months Psychosocial risk factor
Change in Oswestry Baseline, 3, 6 and 12 months Disability index
Change in Movement control tests Change from baseline at 3 month Clinical tests for LBP
Change in Balance measured with computer Change from baseline at 3 month Power plate
Change in Two-point discrimination Change from baseline at 3 month How far apart subject is able to feel two distinctive point of touch
Change in Start back Baseline, 3, 6 and 12 months Screening tool of the psychosocial risk factors
Change in Spinal mouse Change from baseline at 3 month Mobility of the spine
Trial Locations
- Locations (1)
University Hospital of Oulu
🇫🇮Oulu, Finland
University Hospital of Oulu🇫🇮Oulu, Finland