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| Name | Class |
|---|---|
| Loisto Terveys, Oulu | UNKNOWN |
| Fysios Kastelli, Oulu | UNKNOWN |
| Faskia-Markus, Oulu | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Multidisciplinary rehabilitation, no interventions | |
| FM and MCE | Experimental | 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. |
|
| FM and sham-MCE | Other | FM 4-5 times in 3 months and 4 general exercise prescription. |
|
| MCE and sham-FM | Other | Sham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises. |
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| Sham-MCE and sham-FM | Sham Comparator | 4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FM and MCE | Other | Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jani Takatalo, PhD | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Oulu | Oulu | 90029 | Finland |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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
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Participant are not aware which treatment and exercises they will have, physical therapist who perform treatments and exercise prescription were blinded for measurements and each others work. Outcome assessor was blinded for baseline study results and treatment groups. Investigator was blinded for all the work done by others.
| FM and sham-MCE | Other | Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises. |
|
| MCE and sham-FM | Other | 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-MCE and sham-FM | Other | Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises. |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |