Low Back Pain, Low Back Pain, Recurrent
Conditions
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.
Interventions
OTHERFM and sham-MCE
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
OTHERFM and MCE
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
OTHERMCE 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.
OTHERSham-MCE and sham-FM
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
Sponsors
Loisto Terveys, Oulu
Fysios Kastelli, Oulu
Faskia-Markus, Oulu
Oulu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS | Baseline, 3, 6 and 12 months | Quality of life |
| 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 Start back | Baseline, 3, 6 and 12 months | Screening tool of the psychosocial risk factors |
| Change in Movement control tests | Change from baseline at 3 month | Clinical tests for LBP |
| Change in Oswestry | Baseline, 3, 6 and 12 months | Disability index |
| Change in Balance measured with computer | Change from baseline at 3 month | Power plate |
| Change in Mobility of the hips | Change from baseline at 3 month | Hip ROM |
| 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 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 Spinal mouse | Change from baseline at 3 month | Mobility of the spine |
Countries
Finland
Outcome results
None listed