Diaphragmatic Release for Low Back Pain

NCT07298109 | Recruiting

• 1 other identifier: Low back pain-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Diaphragm; Relaxation

Outcome Measures

Primary Outcomes (5)

• Pain severity

  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

  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

  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

  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

  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)

Study Arms (2)

Treatment Group

EXPERIMENTAL

In addition to spinal stabilization exercises, patients will undergo manual diaphragmatic release three times a week for eight weeks.

Other: Manual diaphragm release

Control Group

OTHER

Patients in the control group will receive spinal stabilization exercises three times a week for eight weeks.

Other: Control

Interventions

Manual diaphragm release OTHER

In addition to spinal stabilization exercises, patients will perform diaphragmatic relaxation exercises three days a week for eight weeks.

Treatment Group

Control OTHER

Patients will undergo spinal stabilization exercises three times a week for eight weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa Güneş, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Mustafa Kavak, PhD

  Karabuk University

  PRINCIPAL INVESTIGATOR

• Aydın Sinan Apaydın, MD

  Karabuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Musa Güneş, PhD

CONTACT

03704789081; musagunes@karabuk.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 23, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)