Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

NCT03270631 | Enrolling By Invitation

• 1 other identifier: FM&KCStudy
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Low Back Pain, Recurrent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Change in Oswestry

  Baseline, 3, 6 and 12 months

• Change in PROMIS

  Baseline, 3, 6 and 12 months

• Change in Tampa Scale of Kinesiophobia

  Baseline, 3, 6 and 12 months

• Change in Visual analogue Scale

  Baseline, 3, 6 and 12 months

• Change in Linton Örebro

  Baseline, 3, 6 and 12 months

Study Arms (5)

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.

Other: FM and MCE

FM and sham-MCE

OTHER

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

Other: FM and sham-MCE

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.

Other: MCE and sham-FM

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.

Other: Sham-MCE and sham-FM

Interventions

FM and MCE OTHER

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

FM and MCE

FM and sham-MCE OTHER

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

FM and sham-MCE

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.

MCE and sham-FM

Sham-MCE and sham-FM OTHER

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

Sham-MCE and sham-FM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.

You may not qualify if:

• Specific low back pain cause and earlier fascial manipulation treatment given.

Sponsors & Collaborators

• Oulu University Hospital: lead
• Loisto Terveys, Oulu: collaborator
• Fysios Kastelli, Oulu: collaborator
• Faskia-Markus, Oulu: collaborator

Study Sites (1)

University Hospital of Oulu

Oulu, 90029, Finland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jani Takatalo, PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of PRM, PhD, MD

Model Details: 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

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: August 28, 2017
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FI (1)