Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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: 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.

Conditions

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Low Back Pain Low Back Pain, Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Control

Multidisciplinary rehabilitation, no interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

FM and MCE

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.

Group Type EXPERIMENTAL

FM and MCE

Intervention Type OTHER

Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.

FM and sham-MCE

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

Group Type OTHER

FM and sham-MCE

Intervention Type OTHER

Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.

MCE and sham-FM

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

Group Type OTHER

MCE and sham-FM

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Sham-MCE and sham-FM

Intervention Type OTHER

Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.

Interventions

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FM and MCE

Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.

Intervention Type OTHER

FM and sham-MCE

Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.

Intervention Type OTHER

MCE 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.

Intervention Type OTHER

Sham-MCE and sham-FM

Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.

Intervention Type OTHER

Eligibility Criteria

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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.