University Hospital of Oulu
Oulu, 90029, Finland
NCT Number: NCT03270631
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.
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Interventional
Not applicable
Oulu, 90029, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 3, 6 and 12 months
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
Disability index
Time frame: Baseline, 3, 6 and 12 months
Quality of life
Time frame: Baseline, 3, 6 and 12 months
Fear of movement
Time frame: Baseline, 3, 6 and 12 months
Pain scale
Time frame: Baseline, 3, 6 and 12 months
Psychosocial risk factor
Time frame: Baseline, 3, 6 and 12 months
Screening tool of the psychosocial risk factors
Time frame: Change from baseline at 3 month
Clinical tests for LBP
Time frame: Change from baseline at 3 month
Mobility of the spine
Time frame: Change from baseline at 3 month
Power plate
Time frame: Change from baseline at 3 month
Hip ROM
Time frame: Change from baseline at 3 month
How far apart subject is able to feel two distinctive point of touch
Time frame: Change from baseline at 3 month
How subject is able to understand right and left of the back
Time frame: Change from baseline at 3 month
Several fascial structures are measured
Oulu University Hospital
Other
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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