Diaphragmatic Release for Low Back Pain

December 11, 2025 updated by: Musa Güneş, Karabuk University

Investigating the Effectiveness of Diaphragmatic Release in Patients With Low Back Pain.

Low back pain is one of the most common musculoskeletal disorders, significantly affecting the quality of life of individuals. In non-specific low back pain, a lack of stabilization in the core region negatively impacts the performance of activities. The diaphragm forms the framework of the core region, and its dysfunction can contribute to both respiratory problems and low back pain. This study will investigate the effects of diaphragm relaxation, added to spinal stabilization exercises, on pain, disability, quality of life, central sensitization, and trunk muscle endurance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low back pain is one of the most common musculoskeletal problems, limiting daily life activities, leading to loss of productivity, and significantly reducing quality of life. In non-specific low back pain, insufficient stabilization in the trunk region and inadequate activation of deep muscles reduce the effectiveness of functional movements and contribute to chronic pain. The diaphragm, a crucial component of trunk stability, plays a critical role not only in respiratory function but also in maintaining spinal stability through the regulation of intra-abdominal pressure. Dysfunction or insufficient relaxation of the diaphragm can lead to changes in breathing patterns, impaired postural control, and persistent low back pain.

Therefore, a better understanding of the diaphragm's role in low back pain mechanisms and its targeting in therapeutic interventions is becoming increasingly important. This study aims to investigate the effects of diaphragm relaxation techniques, applied in addition to spinal stabilization exercises, on pain intensity, disability level, quality of life, central sensitivity, and trunk muscle endurance.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • 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 Contact

Study Locations

  • Turkey (Türkiye)
      • Karabük, Turkey (Türkiye)
        • Recruiting
        • Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between 18-65 years of age
  • Having been diagnosed with chronic non-specific lower back pain (pain between the gluteal folds and the 12th ribs lasting at least 12 weeks and without a known pathoanatomical cause)
  • Being willing to participate in the study

Exclusion Criteria:

  • Psychological disorders, mental disorders, cancer, and severe depression
  • History of primary or metastatic spinal malignancy or spinal fracture
  • Neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
  • Having been diagnosed with advanced osteoporosis
  • Having undergone previous surgery or had an acute infection in the lumbar region

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
In addition to spinal stabilization exercises, patients will undergo manual diaphragmatic release three times a week for eight weeks.
Other: Manual diaphragm release
In addition to spinal stabilization exercises, patients will perform diaphragmatic relaxation exercises three days a week for eight weeks.
Other: Control Group
Patients in the control group will receive spinal stabilization exercises three times a week for eight weeks.
Other: Control
Patients will undergo spinal stabilization exercises three times a week for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: Baseline, After intervention (eight week later)
The severity of back pain will be assessed using the Visual Analog Scale (VAS). Patients choose the appropriate score between 0 and 10. Higher scores indicate higher pain levels.
Baseline, After intervention (eight week later)
Central sensitization
Time Frame: Baseline, After intervention (eight week later)
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Baseline, After intervention (eight week later)
Disability levels
Time Frame: Baseline, After intervention (eight week later)
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Baseline, After intervention (eight week later)
Quality of life level
Time Frame: Baseline, After intervention (eight week later)
In the SF-36 quality of life assessment, each sub-parameter is scored on a scale of 0. 0 is the lowest score and 100 is the highest.
Baseline, After intervention (eight week later)
Trunk muscle endurance
Time Frame: Baseline, After intervention (eight week later)
The endurance of the trunk flexor and extensor muscles will be evaluated. Increasing the duration of the test indicates an increase in endurance.
Baseline, After intervention (eight week later)

Collaborators and Investigators

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

Sponsor

Karabuk University

Investigators

  • Principal Investigator: Musa Güneş, PhD, Karabuk University
  • Principal Investigator: Mustafa Kavak, PhD, Karabuk University
  • Principal Investigator: Aydın Sinan Apaydın, MD, Karabuk University

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)

December 11, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low back pain-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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