An interventional study of FM and MCE and FM and sham-MCE in Low Back Pain and Low Back Pain, Recurrent, sponsored by Oulu University Hospital. Enrolling by invitation at 1 site in Finland. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Multidisciplinary rehabilitation, no interventions
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
FM 4-5 times in 3 months and 4 general exercise prescription.
Other: FM and sham-MCE
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
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
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
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.
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
Change in Patient Specific Functional Scale (PSFS)
Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
Time frame: Baseline, 3, 6 and 12 months
Change in Oswestry
Disability index
Time frame: Baseline, 3, 6 and 12 months
Change in PROMIS
Quality of life
Time frame: Baseline, 3, 6 and 12 months
Change in Tampa Scale of Kinesiophobia
Fear of movement
Time frame: Baseline, 3, 6 and 12 months
Change in Visual analogue Scale
Pain scale
Time frame: Baseline, 3, 6 and 12 months
Change in Linton Örebro
Psychosocial risk factor
Time frame: Baseline, 3, 6 and 12 months
Change in Start back
Screening tool of the psychosocial risk factors
Time frame: Baseline, 3, 6 and 12 months
Change in Movement control tests
Clinical tests for LBP
Time frame: Change from baseline at 3 month
Change in Spinal mouse
Mobility of the spine
Time frame: Change from baseline at 3 month
Change in Balance measured with computer
Power plate
Time frame: Change from baseline at 3 month
Change in Mobility of the hips
Hip ROM
Time frame: Change from baseline at 3 month
Change in Two-point discrimination
How far apart subject is able to feel two distinctive point of touch
Time frame: Change from baseline at 3 month
Change in Lef-right discrimination
How subject is able to understand right and left of the back
Time frame: Change from baseline at 3 month
Change in Ultrasound of the fascia
Several fascial structures are measured
Time frame: Change from baseline at 3 month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Oulu University Hospital