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RecruitingNCT07298109Updated Dec 23, 2025

Diaphragmatic Release for Low Back Pain

An interventional study of Manual diaphragm release and Control in Low Back Pain and Diaphragm; Relaxation, sponsored by Karabuk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Karabuk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Back Pain
  • Diaphragm; Relaxation

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03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's planned enrollment of 42 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Karabuk University is the lead sponsor of 126 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
42 participants (estimated)

Study arms

  • 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

  • Other
    Control Group

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

    Other: Control

Interventions

  • OtherManual diaphragm release

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

  • OtherControl

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, After intervention (eight week later)

  2. 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.

    Time frame: Baseline, After intervention (eight week later)

  3. 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.

    Time frame: Baseline, After intervention (eight week later)

  4. 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.

    Time frame: Baseline, After intervention (eight week later)

  5. 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.

    Time frame: Baseline, After intervention (eight week later)

07

Study locations

1 of 1 sites recruiting
  • Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
    Karabük, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07298109
Lead sponsor
Karabuk University
Responsible party
Musa Güneş (Principal Investigator, PhD, Karabuk University) — Principal investigator
First posted
Dec 23, 2025
Start date
Dec 11, 2025
Primary completion
Oct 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Dec 23, 2025

Study contacts

Musa Güneş, PhD
Contact
musagunes@karabuk.edu.tr
03704789081
Musa Güneş, PhD
principal investigator · Karabuk University
Mustafa Kavak, PhD
principal investigator · Karabuk University
Aydın Sinan Apaydın, MD
principal investigator · Karabuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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