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Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Primary Purpose

Low Back Pain, Low Back Pain, Recurrent

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
FM and MCE
FM and sham-MCE
MCE and sham-FM
Sham-MCE and sham-FM
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital of Oulu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Other

Other

Sham Comparator

Arm Label

Control

FM and MCE

FM and sham-MCE

MCE and sham-FM

Sham-MCE and sham-FM

Arm Description

Multidisciplinary rehabilitation, no interventions

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.

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

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

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

Outcomes

Primary Outcome Measures

Change in Patient Specific Functional Scale (PSFS)
Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2017
Last Updated
April 23, 2022
Sponsor
Oulu University Hospital
Collaborators
Loisto Terveys, Oulu, Fysios Kastelli, Oulu, Faskia-Markus, Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT03270631
Brief Title
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
Official Title
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital
Collaborators
Loisto Terveys, Oulu, Fysios Kastelli, Oulu, Faskia-Markus, Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Low Back Pain, Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Multidisciplinary rehabilitation, no interventions
Arm Title
FM and MCE
Arm Type
Experimental
Arm 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.
Arm Title
FM and sham-MCE
Arm Type
Other
Arm Description
FM 4-5 times in 3 months and 4 general exercise prescription.
Arm Title
MCE and sham-FM
Arm Type
Other
Arm 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.
Arm Title
Sham-MCE and sham-FM
Arm Type
Sham Comparator
Arm Description
4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points.
Intervention Type
Other
Intervention Name(s)
FM and MCE
Intervention Description
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
Intervention Type
Other
Intervention Name(s)
FM and sham-MCE
Intervention Description
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
Intervention Type
Other
Intervention Name(s)
MCE and sham-FM
Intervention Description
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
Intervention Name(s)
Sham-MCE and sham-FM
Intervention Description
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
Primary Outcome Measure Information:
Title
Change in Patient Specific Functional Scale (PSFS)
Description
Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Change in Oswestry
Description
Disability index
Time Frame
Baseline, 3, 6 and 12 months
Title
Change in PROMIS
Description
Quality of life
Time Frame
Baseline, 3, 6 and 12 months
Title
Change in Tampa Scale of Kinesiophobia
Description
Fear of movement
Time Frame
Baseline, 3, 6 and 12 months
Title
Change in Visual analogue Scale
Description
Pain scale
Time Frame
Baseline, 3, 6 and 12 months
Title
Change in Linton Örebro
Description
Psychosocial risk factor
Time Frame
Baseline, 3, 6 and 12 months
Title
Change in Start back
Description
Screening tool of the psychosocial risk factors
Time Frame
Baseline, 3, 6 and 12 months
Title
Change in Movement control tests
Description
Clinical tests for LBP
Time Frame
Change from baseline at 3 month
Title
Change in Spinal mouse
Description
Mobility of the spine
Time Frame
Change from baseline at 3 month
Title
Change in Balance measured with computer
Description
Power plate
Time Frame
Change from baseline at 3 month
Title
Change in Mobility of the hips
Description
Hip ROM
Time Frame
Change from baseline at 3 month
Title
Change in Two-point discrimination
Description
How far apart subject is able to feel two distinctive point of touch
Time Frame
Change from baseline at 3 month
Title
Change in Lef-right discrimination
Description
How subject is able to understand right and left of the back
Time Frame
Change from baseline at 3 month
Title
Change in Ultrasound of the fascia
Description
Several fascial structures are measured
Time Frame
Change from baseline at 3 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jani Takatalo, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Oulu
City
Oulu
ZIP/Postal Code
90029
Country
Finland

12. IPD Sharing Statement

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Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

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