Effects of Myofascial Techniques on Chronic Low Back Pain

October 31, 2026 updated by: Muhammed Samed DALAKÇI, Kirsehir Ahi Evran Universitesi

Myofascial Approaches in Chronic Low Back Pain: Effects of Local Application and Superficial Back Line Techniques on Clinical Outcomes

Participants with chronic low back pain will be randomly allocated to three groups: conservative treatment, conservative treatment plus local myofascial release, or conservative treatment plus superficial back line myofascial release. All groups will receive treatment three times weekly for six weeks. The conservative treatment program will include stretching, strengthening, and postural exercises. Myofascial release will be performed using a roller bar, with controlled rhythmic pressure applied for 30-60 seconds per region, totaling 10-15 minutes per session, according to individual tolerance. Age, height, weight, and body mass index will be recorded. Outcomes will include pain intensity (Visual Analog Scale), pressure pain threshold (digital algometer), range of motion (goniometer), static and dynamic balance (Biodex Balance System), and functional disability (Oswestry Disability Index). All outcomes will be assessed before and after the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Chronic low back pain is a common musculoskeletal condition that can negatively affect physical function, postural control, mobility, and quality of life. In addition to conventional exercise-based interventions, myofascial release techniques have been used to address soft tissue restrictions and improve musculoskeletal function. However, the effects of applying myofascial release locally to the lumbar region compared with applying it along the Superficial Back Line have not been sufficiently clarified in individuals with chronic low back pain.

The aim of this study is to investigate and compare the effects of local lumbar myofascial release and Superficial Back Line myofascial release, when combined with conservative treatment, on pain intensity, pressure pain threshold, lumbar range of motion, static and dynamic balance, and functional disability in individuals with chronic low back pain.

Participants diagnosed with chronic low back pain will be randomly allocated to one of three intervention groups: (1) conservative treatment alone, (2) conservative treatment combined with local lumbar myofascial release, and (3) conservative treatment combined with myofascial release applied along the Superficial Back Line. All interventions will be administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.

The conservative treatment program will be applied to all three groups and will consist of stretching, strengthening, and postural exercises designed to address the physical limitations associated with chronic low back pain. Participants in the second group will additionally receive local myofascial release targeting the lumbar region. Participants in the third group will receive myofascial release along the Superficial Back Line, targeting the posterior myofascial structures according to the intervention protocol.

Myofascial release will be performed using a roller bar. Controlled and rhythmic pressure will be applied for approximately 60 seconds per treatment region. The total duration of the myofascial release application will be approximately 10-15 minutes per session, depending on the treatment protocol and individual participant tolerance.

Demographic and anthropometric characteristics, including age, height, and body weight, will be recorded, and body mass index will be calculated.

Clinical outcomes will be evaluated before and after the six-week intervention period. Pain intensity will be assessed using the Visual Analog Scale (VAS), while pressure pain threshold will be measured using a digital algometer. Lumbar range of motion will be evaluated using a goniometer. Static and dynamic balance will be assessed using the Biodex Balance System. Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).

The changes in clinical outcomes within each group and the differences between the three intervention groups will be analyzed to determine whether adding local lumbar myofascial release or Superficial Back Line myofascial release to conservative treatment provides additional benefits. The study will also compare the effects of the two myofascial approaches to determine whether the location and extent of myofascial application influence clinical outcomes in individuals with chronic low back pain.

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.
60

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Aged 18-65 years.
  • Presence of mechanically induced low back pain.
  • Willingness to participate in the study.
  • No neurological, rheumatological, or advanced degenerative spinal pathology.
  • No lumbar surgery within the previous three months.
  • No history of serious systemic diseases, such as advanced cardiovascular, neurological, or metabolic disorders.
  • Sufficient cognitive ability to understand and follow the treatment procedures. Exclusion Criteria
  • Pregnancy.
  • Active infection or malignancy.
  • Severe osteoporosis.
  • Spinal instability.
  • History of lumbar surgery.
  • Severe neurological deficits, such as substantial motor loss or progressive neurological symptoms.
  • Ongoing intensive physical therapy or manual therapy.
  • Psychiatric or cognitive disorders that may prevent participation in the study.

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: Single

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.
Sham Comparator: Conservative treatment

Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated.
Other: Conservative treatment

Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated.
Experimental: Local Myofascial Release

Myofascial release targeting only the lumbar region will be performed in addition to conservative treatment.
Other: Conservative treatment

Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated.

Device: Local Myofascial Release

Myofascial release targeting only the lumbar region will be performed in addition to conservative treatment.
Experimental: Superficial Back Line Myofascial Release

Myofascial release will be applied along the entire superficial back line in addition to conservative treatment.
Other: Conservative treatment

Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated.

Device: Superficial Back Line Myofascial Release

Myofascial release will be applied along the entire superficial back line in addition to conservative treatment.

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 Pain Intensity from Baseline to Week 6
Time Frame: Baseline and Week 6

Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain intensity on a 10-cm line, with 0 indicating no pain and 10 indicating the worst imaginable pain. The change in pain intensity from baseline to the end of the intervention will be evaluated.
Baseline and Week 6

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 Balance Performance from Baseline to Week 6
Time Frame: Baseline and Week 6

Balance performance will be assessed using [Biodex Blance System]. Changes in balance performance from baseline to the end of the intervention will be evaluated.
Baseline and Week 6
Change in Functional Disability from Baseline to Week 6
Time Frame: Baseline and Week 6

Functional disability will be assessed using [Oswerty Disability Index]. Changes in functional disability scores from baseline to the end of the intervention will be evaluated.
Baseline and Week 6
Change in Lumbar Range of Motion from Baseline to Week 6
Time Frame: Baseline and Week 6

Lumbar range of motion will be assessed using [goniometer]. Changes in lumbar range of motion from baseline to the end of the intervention will be evaluated in degrees.
Baseline and Week 6

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.
Kirsehir Ahi Evran Universitesi

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 (Estimated)

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.
November 1, 2026

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.
January 1, 2027

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.
January 1, 2027

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).
October 27, 2026

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.
October 31, 2026

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.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

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.
November 4, 2026

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.
October 31, 2026

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.
October 1, 2026

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.
  • samed.dalakci

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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