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Recruiting NCT07298109

Diaphragmatic Release for Low Back Pain

No phase Interventional Low Back Pain Diaphragm; Relaxation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual diaphragm release, Control.
Who it may be relevant to
Registry conditions: Low Back Pain, Diaphragm; Relaxation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Pain severity [Time frame: Baseline, After intervention (eight week later)]
  • Central sensitization [Time frame: Baseline, After intervention (eight week later)]
  • Disability levels [Time frame: Baseline, After intervention (eight week later)]
  • Quality of life level [Time frame: Baseline, After intervention (eight week later)]
  • Trunk muscle endurance [Time frame: Baseline, After intervention (eight week later)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Karabuk University, Physiotherapy and Rehabilitation Application and Research Center — Karabük

Identifiers

NCT: NCT07298109 · Low back pain-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗