Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03270631
• Other study ID #: FM&KCStudy
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

Other:
• FM and MCE
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
• FM and sham-MCE
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
• 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-MCE and sham-FM
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.

Locations

Country	Name	City	State
Finland	University Hospital of Oulu	Oulu

Sponsors (4)

Lead Sponsor	Collaborator
Oulu University Hospital	Faskia-Markus, Oulu, Fysios Kastelli, Oulu, Loisto Terveys, Oulu

Country where clinical trial is conducted

Finland, 

Outcome

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