Low Back PainNCT07298109
Diaphragmatic Release for Low Back Pain
A study testing Manual diaphragm release in people with Low Back Pain and Diaphragm; Relaxation, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Diaphragm; Relaxation
- What is being tested?
- Manual diaphragm release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Karabük
Musa Güneş, PhD, 03704189081, musagunes@karabuk.edu.tr
About this study
Official title: Investigating the Effectiveness of Diaphragmatic Release in Patients With 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.
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.
- Conditions
- Low Back Pain, Diaphragm; Relaxation
- Being tested
- Manual diaphragm release, Control
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual diaphragm releaseOther
In addition to spinal stabilization exercises, patients will perform diaphragmatic relaxation exercises three days a week for eight weeks.
ControlOther
Patients will undergo spinal stabilization exercises three times a week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | In addition to spinal stabilization exercises, patients will undergo manual diaphragmatic release three times a week for eight weeks. Receives: Other: Manual diaphragm release |
| Control Group | Other | Patients in the control group will receive spinal stabilization exercises three times a week for eight weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, After intervention (eight week later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start11 Dec 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Güneş, PhD, Principal investigator, Karabuk UniversityMustafa Kavak, PhD, Principal investigator, Karabuk UniversityAydın Sinan Apaydın, MD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298109
- Sponsor's protocol ID
- Low back pain-01
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Diaphragmatic Release in Patients With Low Back Pain.
- ClinicalTrials.gov ID
- NCT07298109
- Acronym / sponsor ID
- Low back pain-01
- Conditions
- Low Back Pain, Diaphragm; Relaxation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Manual diaphragm releaseIn addition to spinal stabilization exercises, patients will undergo manual diaphragmatic release three times a week for eight weeks. |
| Control Group | Other | Other: ControlPatients in the control group will receive spinal stabilization exercises three times a week for eight weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual diaphragm releaseIn addition to spinal stabilization exercises, patients will perform diaphragmatic relaxation exercises three days a week for eight weeks. | Other | Treatment Group |
| ControlPatients will undergo spinal stabilization exercises three times a week for eight weeks. | Other | Control Group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Musa Güneş, PhD principal investigator
Karabuk University
Mustafa Kavak, PhD principal investigator
Karabuk University
Aydın Sinan Apaydın, MD principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual diaphragm release in people with Low Back Pain and Diaphragm; Relaxation, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Musa Güneş, PhD (03704789081, musagunes@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: Baseline, After intervention (eight week later)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.