Clinical trial NCT03270631: Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
Official title: Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Back Pain
Low Back Pain, Recurrent
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Loisto Terveys, Oulu
name: Fysios Kastelli, Oulu
name: Faskia-Markus, Oulu
First posted: 2017-09-01
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient Specific Functional Scale (PSFS)
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Change in Oswestry
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in PROMIS
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in Tampa Scale of Kinesiophobia
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in Visual analogue Scale
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in Linton Örebro
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in Start back
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in Movement control tests
timeFrame: Change from baseline at 3 month
measure: Change in Spinal mouse
timeFrame: Change from baseline at 3 month
measure: Change in Balance measured with computer
timeFrame: Change from baseline at 3 month
measure: Change in Mobility of the hips
timeFrame: Change from baseline at 3 month
measure: Change in Two-point discrimination
timeFrame: Change from baseline at 3 month
measure: Change in Lef-right discrimination
timeFrame: Change from baseline at 3 month
measure: Change in Ultrasound of the fascia
timeFrame: Change from baseline at 3 month
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University Hospital of Oulu
Study officials:
affiliation: Oulu University Hospital
name: Jani Takatalo, PhD
role: PRINCIPAL_INVESTIGATOR
References: