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NCT Number: NCT07298109

Diaphragmatic Release for 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.

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Key information

Conditions

Low Back Pain Back Pain Diaphragm; Relaxation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

Location status: Recruiting

Location contact

Musa Güneş, PhD

CONTACT

[email protected]

03704189081

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Diaphragm Release

Other

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

Control

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Musa Güneş, PhD

CONTACT

[email protected]

03704789081

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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