Low Back PainNCT07022132
Comparison of Physiotherapy Methods Applied To The Diaphragm In Chronic Low Back Pain
A study testing Diaphragmatic myofascial release (DMR), Abdominal hypopressive exercise (AHE) and Conservative treatment in people with Low Back Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of conservative treatment with diaphragmatic myofascial release (DMR) and abdominal hypopressive exercise (AHE) technique added to conservative treatment in chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Diaphragmatic myofascial release (DMR), Abdominal hypopressive exercise (AHE) and Conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing low back pain for at least 12 weeks
- To be between the ages of 18-65
Who cannot join
- Pregnancy
- Severe osteoporosis
- Less than 1 year history of abdominal and/or thoracic surgery
- Having an additional disease such as severe coronary artery disease, uncontrolled hypertension, COPD that prevents exercise,
- Difficulty in co-operation
- History of malignancy
Show all 11Show fewer
- History of lumbar spinal surgery
- Spondylolisthesis, scoliosis, other spinal deformities and congenital malformations
- Radiculopathy
- Systemic inflammatory diseases
- Corticosteroid injection in the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Istanbul, 34810
About this study
Official title: Effects of Diaphragm Manual Therapy and Abdominal Hyporesive Exercises in Chronic Low Back Pain
The aim of this study was to compare the effects of conservative treatment with diaphragmatic myofascial release (DMR) and abdominal hypopressive exercise (AHE) technique added to conservative treatment in chronic low back pain.
Read the detailed description
Low back pain is one of the most common health problems in all societies and is a problem encountered by most individuals at some point in lifetime. Epidemiologic studies have shown that 70-80% of people complain of low back pain at some point in their lives. Low back pain, which ranks first in terms of chronic pain, causes pain, decreased normal joint movements, joint stiffness, loss of flexibility and activity limitations in individuals. These problems also cause difficulties in activities of daily living, decreased physical activity level, fear of movement and psychological stress, loss of work and performance, increased health expenditures and increased costs for employers.
Low back pain is often managed as a disease limited to isolated lumbar structures, but it often occurs in association with respiratory dysfunction, suggesting that low back pain is not an isolated musculoskeletal problem. Interestingly, the association between low back pain and respiratory disorders appears to be even stronger than the association with obesity and physical activity.
Due to its complex structure, the diaphragm has an important place in the postural chain. In addition to respiratory function, the diaphragm also plays an important role in stabilizing the spine during posture, balance and load-bearing activities, and therefore it is reasonable to assume that diaphragmatic dysfunction may also trigger low back problems.
Passive myofascial techniques are used to restore normal movement of the diaphragm and improve its function. It creates a greater pressure gradient between the thorax and abdomen and increases the expiratory phase. The biomechanical relationship between the diaphragm and other structures indicates that diaphragm techniques may have an effect on distal structures such as the Hamstring muscles, contributing to motor control and stabilization through activation of core stabilization muscles.
Training the muscles that form trunk stability can help improve low back pain. One of these training methods is the increasingly popular abdominal hypopressive exercises. The abdominal hypopressive exercise (AHE) technique was proposed by Marcel Caufriez in the 1980s for the treatment of pelvic floor disorders. The hypothesis of this method, which combines respiratory technique with abdominal contraction maneuvers, is that it relaxes the diaphragm, lowers intra-abdominal pressure and activates the abdominal muscles and pelvic floor simultaneously. Thus, it is suggested that urinary incontinence and pelvic organ prolapse can be reduced and that it can produce direct activation of the Transversus Abdominis muscle, which can strengthen the abdominal wall and stabilize the spine, increase the flexibility of the lumbar spine and Hamstring muscles, and reorganize body posture.
The aim of this study was to compare the effects of abdominal hypopressive exercise technique and myofascial diaphragm relaxation technique on pain, pressure pain threshold, functional status, range of motion, chest wall mobility, spinal mobility, flexibility and pelvic floor muscle activity in chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Diaphragmatic myofascial release (DMR), Abdominal hypopressive exercise (AHE), Conservative treatment
- 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.
Diaphragmatic myofascial release (DMR)Other
The physiotherapist, positioned on the head side of the supine patient, makes bilateral contact with the pisiform, hypothenar region and the underside of the 7th-10th costal cartilages with the last three fingers. During the inspiration phase, he/she pulls the contact points cephalically and slightly laterally with both hands, accompanying the elevation of the costae. During expiration, it deepens the contact towards the inner costal margin, maintaining resistance. In subsequent breathing cycles, it gradually increases the depth of contact inside the costal margin. The application is performed in 2 sets of 10 deep breaths with 1 minute between them.
Abdominal hypopressive exercise (AHE)Other
Each session consists of 6 hypopressive abdominal exercises with a 2-minute recovery period in between, and each exercise is repeated 3 times. This manoeuvre consists of expelling all air until the reserve volume is reached, then holding the breath (expiratory apnoea) and pulling the abdominal wall inwards and cranially by opening the costae without allowing air to enter. Exercises are performed in 6 different positions.
Conservative treatmentOther
It consists of lumbar flexion and extension, stretching and strengthening exercises for the waist, back and abdominal region.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic myofascial release (DMR) group | Active comparator | This group will receive DMR in addition to conservative treatment consisting of stretching and strengthening exercises. Receives: Other: Diaphragmatic myofascial release (DMR); Other: Conservative treatment |
| Abdominal hypopressive exercise (AHE) group | Active comparator | This group will receive AHE in addition to conservative treatment consisting of stretching and strengthening exercises. Receives: Other: Abdominal hypopressive exercise (AHE); Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual Analogue Scale)
The Visual Analogue Scale (VAS) will be used to assess the level of pain at rest and during movement. The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 100 millimetres long, with two verbal descriptors indicating pain status at the extremes. The patient is asked to indicate where on this line his/her condition fits by drawing a line, putting a dot or pointing.
Measured: 6 weeks
Secondary outcomes (3)
Hamstring flexibility (The Active Knee Extension Test)
The Active Knee Extension Test (AKET) starts in the supine position with the hip and knee in 90° flexion. In this position and with the axis of the goniometer placed on the lateral condyle of the femur, the subject is asked to perform knee extension without changing the flexion of the hip and avoiding pelvic movements. The angle remaining for full extension of the knee reflects the degree of hamstring shortening.
Measured: 6 weeks
Chest wall mobility (a tape measure)
Chest wall mobility will be measured with a tape measure during full inspiration and full expiration.
Measured: 6 weeks
Pelvic floor muscle activity
Pelvic floor muscle activity will be evaluated by surface EMG.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start10 Aug 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
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.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humeyra Akil, Medipol University
- Investigators
- Hatice Hümeyra Akıl, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022132
- Sponsor's protocol ID
- IMUFTR01
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm Manual Therapy and Abdominal Hyporesive Exercises in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07022132
- Acronym / sponsor ID
- IMUFTR01
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 15 Jun 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.
The aim of this study was to compare the effects of conservative treatment with diaphragmatic myofascial release (DMR) and abdominal hypopressive exercise (AHE) technique added to conservative treatment in chronic low back pain.
Detailed description
Low back pain is one of the most common health problems in all societies and is a problem encountered by most individuals at some point in lifetime. Epidemiologic studies have shown that 70-80% of people complain of low back pain at some point in their lives. Low back pain, which ranks first in terms of chronic pain, causes pain, decreased normal joint movements, joint stiffness, loss of flexibility and activity limitations in individuals. These problems also cause difficulties in activities of daily living, decreased physical activity level, fear of movement and psychological stress, loss of work and performance, increased health expenditures and increased costs for employers.
Low back pain is often managed as a disease limited to isolated lumbar structures, but it often occurs in association with respiratory dysfunction, suggesting that low back pain is not an isolated musculoskeletal problem. Interestingly, the association between low back pain and respiratory disorders appears to be even stronger than the association with obesity and physical activity.
Due to its complex structure, the diaphragm has an important place in the postural chain. In addition to respiratory function, the diaphragm also plays an important role in stabilizing the spine during posture, balance and load-bearing activities, and therefore it is reasonable to assume that diaphragmatic dysfunction may also trigger low back problems.
Passive myofascial techniques are used to restore normal movement of the diaphragm and improve its function. It creates a greater pressure gradient between the thorax and abdomen and increases the expiratory phase. The biomechanical relationship between the diaphragm and other structures indicates that diaphragm techniques may have an effect on distal structures such as the Hamstring muscles, contributing to motor control and stabilization through activation of core stabilization muscles.
Training the muscles that form trunk stability can help improve low back pain. One of these training methods is the increasingly popular abdominal hypopressive exercises. The abdominal hypopressive exercise (AHE) technique was proposed by Marcel Caufriez in the 1980s for the treatment of pelvic floor disorders. The hypothesis of this method, which combines respiratory technique with abdominal contraction maneuvers, is that it relaxes the diaphragm, lowers intra-abdominal pressure and activates the abdominal muscles and pelvic floor simultaneously. Thus, it is suggested that urinary incontinence and pelvic organ prolapse can be reduced and that it can produce direct activation of the Transversus Abdominis muscle, which can strengthen the abdominal wall and stabilize the spine, increase the flexibility of the lumbar spine and Hamstring muscles, and reorganize body posture.
The aim of this study was to compare the effects of abdominal hypopressive exercise technique and myofascial diaphragm relaxation technique on pain, pressure pain threshold, functional status, range of motion, chest wall mobility, spinal mobility, flexibility and pelvic floor muscle activity in chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic myofascial release (DMR) group | Active comparator | Other: Diaphragmatic myofascial release (DMR), Other: Conservative treatmentThis group will receive DMR in addition to conservative treatment consisting of stretching and strengthening exercises. |
| Abdominal hypopressive exercise (AHE) group | Active comparator | Other: Abdominal hypopressive exercise (AHE), Other: Conservative treatmentThis group will receive AHE in addition to conservative treatment consisting of stretching and strengthening exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experiencing low back pain for at least 12 weeks
- To be between the ages of 18-65
Key exclusion criteria (11 listed)
- Pregnancy
- Severe osteoporosis
- Less than 1 year history of abdominal and/or thoracic surgery
- Having an additional disease such as severe coronary artery disease, uncontrolled hypertension, COPD that prevents exercise,
- Difficulty in co-operation
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 |
|---|---|---|
| Diaphragmatic myofascial release (DMR)The physiotherapist, positioned on the head side of the supine patient, makes bilateral contact with the pisiform, hypothenar region and the underside of the 7th-10th costal cartilages with the last three fingers. During the inspiration phase, he/she pulls the contact points cephalically and slightly laterally with both hands, accompanying the elevation of the costae. During expiration, it deepens the contact towards the inner costal margin, maintaining resistance. In subsequent breathing cycles, it gradually increases the depth of contact inside the costal margin. The application is performed in 2 sets of 10 deep breaths with 1 minute between them. | Other | Diaphragmatic myofascial release (DMR) group |
| Abdominal hypopressive exercise (AHE)Each session consists of 6 hypopressive abdominal exercises with a 2-minute recovery period in between, and each exercise is repeated 3 times. This manoeuvre consists of expelling all air until the reserve volume is reached, then holding the breath (expiratory apnoea) and pulling the abdominal wall inwards and cranially by opening the costae without allowing air to enter. Exercises are performed in 6 different positions. | Other | Abdominal hypopressive exercise (AHE) group |
| Conservative treatmentIt consists of lumbar flexion and extension, stretching and strengthening exercises for the waist, back and abdominal region. | Other | Abdominal hypopressive exercise (AHE) group, Diaphragmatic myofascial release (DMR) group |
Primary outcome
Pain intensity (Visual Analogue Scale)
Time frame: 6 weeks
The Visual Analogue Scale (VAS) will be used to assess the level of pain at rest and during movement. The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 100 millimetres long, with two verbal descriptors indicating pain status at the extremes. The patient is asked to indicate where on this line his/her condition fits by drawing a line, putting a dot or pointing.
3 secondary outcomes
Hamstring flexibility (The Active Knee Extension Test)
Time frame: 6 weeks
Chest wall mobility (a tape measure)
Time frame: 6 weeks
Pelvic floor muscle activity
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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. This study is not recruiting at the moment.
Hatice Hümeyra Akıl principal investigator
Medipol 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 Diaphragmatic myofascial release (DMR), Abdominal hypopressive exercise (AHE) and Conservative treatment in people with Low Back Pain, run by Medipol 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 2 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Visual Analogue Scale) (time frame: 6 weeks). 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 2 Jan 2026.