Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain; Low Back Pain, Recurrent
• Intervention / Treatment: Other: FM and MCE; Other: FM and sham-MCE; Other: MCE and sham-FM; Other: Sham-MCE and sham-FM

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029
    • University Hospital of Oulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Multidisciplinary rehabilitation, no interventions
Experimental: 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.	Other: FM and MCE; Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
Other: FM and sham-MCE; FM 4-5 times in 3 months and 4 general exercise prescription.	Other: FM and sham-MCE; Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
Other: 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.	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.
Sham Comparator: 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.	Other: Sham-MCE and sham-FM; Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oswestry	Disability index	Baseline, 3, 6 and 12 months
Change in PROMIS	Quality of life	Baseline, 3, 6 and 12 months
Change in Tampa Scale of Kinesiophobia	Fear of movement	Baseline, 3, 6 and 12 months
Change in Visual analogue Scale	Pain scale	Baseline, 3, 6 and 12 months
Change in Linton Örebro	Psychosocial risk factor	Baseline, 3, 6 and 12 months
Change in Start back	Screening tool of the psychosocial risk factors	Baseline, 3, 6 and 12 months
Change in Movement control tests	Clinical tests for LBP	Change from baseline at 3 month
Change in Spinal mouse	Mobility of the spine	Change from baseline at 3 month
Change in Balance measured with computer	Power plate	Change from baseline at 3 month
Change in Mobility of the hips	Hip ROM	Change from baseline at 3 month
Change in Two-point discrimination	How far apart subject is able to feel two distinctive point of touch	Change from baseline at 3 month
Change in Lef-right discrimination	How subject is able to understand right and left of the back	Change from baseline at 3 month
Change in Ultrasound of the fascia	Several fascial structures are measured	Change from baseline at 3 month

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Loisto Terveys, Oulu; Fysios Kastelli, Oulu; Faskia-Markus, Oulu
• Investigators: Principal Investigator: Jani Takatalo, PhD, Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FM&KCStudy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No