Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

August 27, 2025 updated by: Jani Takatalo, Oulu University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Patient Specific Functional Scale (PSFS)
Time Frame: Baseline, 3, 6 and 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Oswestry
Time Frame: Baseline, 3, 6 and 12 months
Disability index
Baseline, 3, 6 and 12 months
Change in PROMIS
Time Frame: Baseline, 3, 6 and 12 months
Quality of life
Baseline, 3, 6 and 12 months
Change in Tampa Scale of Kinesiophobia
Time Frame: Baseline, 3, 6 and 12 months
Fear of movement
Baseline, 3, 6 and 12 months
Change in Visual analogue Scale
Time Frame: Baseline, 3, 6 and 12 months
Pain scale
Baseline, 3, 6 and 12 months
Change in Linton Örebro
Time Frame: Baseline, 3, 6 and 12 months
Psychosocial risk factor
Baseline, 3, 6 and 12 months
Change in Start back
Time Frame: Baseline, 3, 6 and 12 months
Screening tool of the psychosocial risk factors
Baseline, 3, 6 and 12 months
Change in Movement control tests
Time Frame: Change from baseline at 3 month
Clinical tests for LBP
Change from baseline at 3 month
Change in Spinal mouse
Time Frame: Change from baseline at 3 month
Mobility of the spine
Change from baseline at 3 month
Change in Balance measured with computer
Time Frame: Change from baseline at 3 month
Power plate
Change from baseline at 3 month
Change in Mobility of the hips
Time Frame: Change from baseline at 3 month
Hip ROM
Change from baseline at 3 month
Change in Two-point discrimination
Time Frame: Change from baseline at 3 month
How far apart subject is able to feel two distinctive point of touch
Change from baseline at 3 month
Change in Lef-right discrimination
Time Frame: Change from baseline at 3 month
How subject is able to understand right and left of the back
Change from baseline at 3 month
Change in Ultrasound of the fascia
Time Frame: Change from baseline at 3 month
Several fascial structures are measured
Change from baseline at 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oulu University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loisto Terveys, Oulu
Fysios Kastelli, Oulu
Faskia-Markus, Oulu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jani Takatalo, PhD, Oulu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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