Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Oulu University Hospital

Status: Invitation-only

Conditions: Low Back Pain, Recurrent; Low Back Pain

Treatments: Other: FM and sham-MCE; Other: FM and MCE; Other: MCE and sham-FM; Other: Sham-MCE and sham-FM

Study type: Interventional

Funder types: Other

Identifiers

NCT03270631

FM&KCStudy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 5 patient groups

Control

No Intervention group

Description:

Multidisciplinary rehabilitation, no interventions

FM and MCE

Experimental group

Description:

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.

Treatment:

Other: FM and MCE

FM and sham-MCE

Other group

Description:

FM 4-5 times in 3 months and 4 general exercise prescription.

Treatment:

Other: FM and sham-MCE

MCE and sham-FM

Other group

Description:

Sham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises.

Treatment:

Other: MCE and sham-FM

Sham-MCE and sham-FM

Sham Comparator group

Description:

4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points.

Treatment:

Other: Sham-MCE and sham-FM