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Diaphragmatic Release for Low Back Pain

NCT ID: NCT07298109

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2026-12-15

Brief Summary

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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

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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.

Conditions

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Low Back Pain Diaphragm; Relaxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double blind (Participant, Investigator)

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

Manual diaphragm release

Intervention Type OTHER

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

Control Group

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

Group Type OTHER

Control

Intervention Type OTHER

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

Interventions

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Manual diaphragm release

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

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Musa Güneş

Principal Investigator, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Musa Güneş, PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Mustafa Kavak, PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Aydın Sinan Apaydın, MD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Locations

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Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Musa Güneş, PhD

Role: CONTACT

Phone: 03704789081

Email: [email protected]

Facility Contacts

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Musa Güneş, PhD

Role: primary

Other Identifiers

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Low back pain-01

Identifier Type: -

Identifier Source: org_study_id