Non Specific Low Back PainNCT07167212
Comparative Effect of Diaphragmatic Training in Patients With Chronic Non-specific Low Back Pain
A study testing Diaphragm Training and Myofascial Release Technique in people with Non Specific Low Back Pain, run by Rashid Latif Medical College at 1 site in Pakistan.
Trial summary
Background: The diaphragm muscle is a respiratory muscle with postural function. Patients with chronic LBP (CLBP) are more susceptible to diaphragm fatigue than healthy people and, therefore, can likely benefit from exercises designed to improve strength/endurance in this muscle. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- Diaphragm Training and Myofascial Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2024to 10 Apr 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with intermittent nonspecific CLBP for ≥12 weeks, with VAS between 3 to 7. All participants will be active at a recreational level, history of at least 12 weeks of NLBP, absence of radiculopathy or spinal damage due to tumors, stenosis, or fractures, and a minimum level of physical activity to be able to perform the exercises.
Who cannot join
- lumbar surgery experience,
- inflammatory spinal disease,
- spinal deformities,
- neurologic radiating pain
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Arif Memorial Teaching Hospital
Lahore, Punjab Province, 54900
About this study
Official title: Comparative Effect of Diaphragmatic Training and Myofascial Release on Pain Flexibility and Disability in Patients With Chronic Non-specific Low Back Pain
Background: The diaphragm muscle is a respiratory muscle with postural function. Patients with chronic LBP (CLBP) are more susceptible to diaphragm fatigue than healthy people and, therefore, can likely benefit from exercises designed to improve strength/endurance in this muscle. Studying the results of diaphragmatic training versus myofascial release was a strategy for determining which of them was the most effective in improving pain, flexibility and disability in the patients with chronic non- specific low back pain.
Objective: The objective of the study will be to compare the effect of Diaphragm training and myofascial release back pain patients.
Methods: A randomized clinical trial will be conducted on 44 patients aged 20-45 years. The patients will be randomized using lottery method. Group A will underwent diaphragmatic training with four positions with hot-pack and therapeutic ultrasound as baseline treatment NPRS will be used to measure the intensity of pain, ODI for the measurement of disability and Schober's test for lumbar flexibility before and after the completion of treatment sessions. Group B will receive myofascial release of diaphragm for 15 minutes with two sets of repetition of 10 breaths with a one-minute interval between them. Total duration will be 4 weeks.
- Conditions
- Non Specific Low Back Pain
- Being tested
- Diaphragm Training, Myofascial Release Technique
- Keywords
- Pain, Flexibility, Disability, Strength, Lumbar
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm TrainingOther
The diaphragm serves dual roles in respiration and postural control, yet its contribution is often overlooked in core stability exercise (CSE) programs for low back pain (LBP) rehabilitation. Abdominal hollowing, or the 'tummy tuck,' targets TrA and lumbar multifidus. Diaphragmatic breathing (DB) increases intra-abdominal pressure, contributing to lumbar stability. The intervention included four progressive weeks: Week 1-Supine and Crocodile breathing; Week 2-Supine and Crocodile with TheraBand; Week 3-Seated and 90/90/90 breathing; Week 4-Seated and 90/90/90 with TheraBand. Supine emphasized diaphragmatic expansion with resistance at the thoracolumbar junction; Crocodile focused on lateral rib expansion; Seated required upright posture with rib control; 90/90/90 integrated deep breathing with resisted stabilization. This study evaluates DB combined with CSE on pain, disability, muscle activity, and sleep quality in chronic LBP.
Myofascial Release TechniqueOther
The myofascial release technique for the diaphragm was performed with the participant lying supine and limbs relaxed. The therapist, positioned at the head, placed the pisiform, hypothenar, and last three fingers bilaterally under the seventh to tenth rib costal cartilages, forearms aligned toward the shoulders. During inspiration, gentle traction was applied cephalad and slightly laterally, accompanying rib elevation. On exhalation, pressure was directed inward along the costal margin to maintain resistance. With each breath, traction was gradually deepened to improve release. The maneuver consisted of two sets of 10 deep breaths with a 1-minute rest between sets. Figure 1 illustrates the manual diaphragm release technique (source: author's photo). This method, adapted from Rocha et al. (2015), emphasizes progressive traction and controlled resistance to facilitate diaphragmatic mobility and rib cage expansion.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm Training | Experimental | Diaphragm Training Receives: Other: Diaphragm Training |
| Myofascial Release technique | Active comparator | Myofascial Release technique Receives: Other: Myofascial Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Pain level will be assessed by the Numerical Rating Scale (NRS). The participants rated their pain on a defined 0-10 scale, where 0 is no pain, and 10 is the worst pain imaginable. NRS has different advantages, such as simplicity, reproducibility, and sensitivity to small changes in pain. NRS takes less than 1 min to complete and is a valid and reliable scale to measure pain intensity
Measured: Pre-intervention and 4 weeks Post-intervention
Disability
The disability due to NSLBP will be assessed using the Oswestry Disability Index (ODI), which is a self-administered questionnaire to evaluate the limitations of various daily living activities. The ODI is one of the most common scoring systems used for patients with LBP. The total score ranges from 0 to 100, where a higher score indicates a higher level of disability.
Measured: Pre and 4 week post-intervention
Flexibility
The lumbar flexibility will be measured by Modified Schober test. The examiner puts his thumbs on the inferior margin of the subject's PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the examiner holds the tape firmly against the subject's skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion. Each therapist recorded measurements to the nearest mm
Measured: Pre and 4 weeks Post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start16 Dec 2024
- Primary completion24 Mar 2025
- Study completion10 Apr 2025
Why it stopped: This record is a duplicate of IRCT20220604055072N3, where the trial was prospectively registered. Entered here in error.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non Specific 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rashid Latif Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleena Waheed, Rashid Latif Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167212
- Sponsor's protocol ID
- IRB/2024/213
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
PubMed 36775506Otadi K, Nakhostin Ansari N, Sharify S, Fakhari Z, Sarafraz H, Aria A, Rasouli O. Effects of combining diaphragm training with electrical stimulation on pain, function, and balance in athletes with chronic low back pain: a randomized clinical trial. BMC Sports Sci Med Rehabil. 2021 Mar 4;13(1):20. doi: 10.1186/s13102-021-00250-y.
PubMed 33663607Masroor S, Tanwar T, Aldabbas M, Iram I, Veqar Z. Effect of Adding Diaphragmatic Breathing Exercises to Core Stabilization Exercises on Pain, Muscle Activity, Disability, and Sleep Quality in Patients With Chronic Low Back Pain: A Randomized Control Trial. J Chiropr Med. 2023 Dec;22(4):275-283. doi: 10.1016/j.jcm.2023.07.001. Epub 2023 Sep 2.
PubMed 38205226Oh YJ, Park SH, Lee MM. Comparison of Effects of Abdominal Draw-In Lumbar Stabilization Exercises with and without Respiratory Resistance on Women with Low Back Pain: A Randomized Controlled Trial. Med Sci Monit. 2020 Mar 17;26:e921295. doi: 10.12659/MSM.921295.
PubMed 32182226Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
PubMed 27333481
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Diaphragmatic Training and Myofascial Release on Pain Flexibility and Disability in Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07167212
- Acronym / sponsor ID
- IRB/2024/213
- Conditions
- Non Specific Low Back Pain
- Keywords
- Pain, Flexibility, Disability, Strength, Lumbar
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This record is a duplicate of IRCT20220604055072N3, where the trial was prospectively registered. Entered here in error.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rashid Latif Medical CollegeUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 11 Sep 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.
Background: The diaphragm muscle is a respiratory muscle with postural function. Patients with chronic LBP (CLBP) are more susceptible to diaphragm fatigue than healthy people and, therefore, can likely benefit from exercises designed to improve strength/endurance in this muscle. Studying the results of diaphragmatic training versus myofascial release was a strategy for determining which of them was the most effective in improving pain, flexibility and disability in the patients with chronic non- specific low back pain.
Objective: The objective of the study will be to compare the effect of Diaphragm training and myofascial release back pain patients.
Methods: A randomized clinical trial will be conducted on 44 patients aged 20-45 years. The patients will be randomized using lottery method. Group A will underwent diaphragmatic training with four positions with hot-pack and therapeutic ultrasound as baseline treatment NPRS will be used to measure the intensity of pain, ODI for the measurement of disability and Schober's test for lumbar flexibility before and after the completion of treatment sessions. Group B will receive myofascial release of diaphragm for 15 minutes with two sets of repetition of 10 breaths with a one-minute interval between them. Total duration will be 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm Training | Experimental | Other: Diaphragm TrainingDiaphragm Training |
| Myofascial Release technique | Active comparator | Other: Myofascial Release TechniqueMyofascial Release technique |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- with intermittent nonspecific CLBP for ≥12 weeks, with VAS between 3 to 7. All participants will be active at a recreational level, history of at least 12 weeks of NLBP, absence of radiculopathy or spinal damage due to tumors, stenosis, or fractures, and a minimum level of physical activity to be able to perform the exercises.
Key exclusion criteria (4 listed)
- lumbar surgery experience,
- inflammatory spinal disease,
- spinal deformities,
- neurologic radiating pain
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 |
|---|---|---|
| Diaphragm TrainingThe diaphragm serves dual roles in respiration and postural control, yet its contribution is often overlooked in core stability exercise (CSE) programs for low back pain (LBP) rehabilitation. Abdominal hollowing, or the 'tummy tuck,' targets TrA and lumbar multifidus. Diaphragmatic breathing (DB) increases intra-abdominal pressure, contributing to lumbar stability. The intervention included four progressive weeks: Week 1-Supine and Crocodile breathing; Week 2-Supine and Crocodile with TheraBand; Week 3-Seated and 90/90/90 breathing; Week 4-Seated and 90/90/90 with TheraBand. Supine emphasized diaphragmatic expansion with resistance at the thoracolumbar junction; Crocodile focused on lateral rib expansion; Seated required upright posture with rib control; 90/90/90 integrated deep breathing with resisted stabilization. This study evaluates DB combined with CSE on pain, disability, muscle activity, and sleep quality in chronic LBP. | Other | Diaphragm Training |
| Myofascial Release TechniqueThe myofascial release technique for the diaphragm was performed with the participant lying supine and limbs relaxed. The therapist, positioned at the head, placed the pisiform, hypothenar, and last three fingers bilaterally under the seventh to tenth rib costal cartilages, forearms aligned toward the shoulders. During inspiration, gentle traction was applied cephalad and slightly laterally, accompanying rib elevation. On exhalation, pressure was directed inward along the costal margin to maintain resistance. With each breath, traction was gradually deepened to improve release. The maneuver consisted of two sets of 10 deep breaths with a 1-minute rest between sets. Figure 1 illustrates the manual diaphragm release technique (source: author's photo). This method, adapted from Rocha et al. (2015), emphasizes progressive traction and controlled resistance to facilitate diaphragmatic mobility and rib cage expansion. | Other | Myofascial Release technique |
Primary outcome
Pain Level
Time frame: Pre-intervention and 4 weeks Post-intervention
Pain level will be assessed by the Numerical Rating Scale (NRS). The participants rated their pain on a defined 0-10 scale, where 0 is no pain, and 10 is the worst pain imaginable. NRS has different advantages, such as simplicity, reproducibility, and sensitivity to small changes in pain. NRS takes less than 1 min to complete and is a valid and reliable scale to measure pain intensity
Disability
Time frame: Pre and 4 week post-intervention
The disability due to NSLBP will be assessed using the Oswestry Disability Index (ODI), which is a self-administered questionnaire to evaluate the limitations of various daily living activities. The ODI is one of the most common scoring systems used for patients with LBP. The total score ranges from 0 to 100, where a higher score indicates a higher level of disability.
Flexibility
Time frame: Pre and 4 weeks Post intervention
The lumbar flexibility will be measured by Modified Schober test. The examiner puts his thumbs on the inferior margin of the subject's PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the examiner holds the tape firmly against the subject's skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion. Each therapist recorded measurements to the nearest mm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 36775506Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
- Results publication: PubMed 33663607Otadi K, Nakhostin Ansari N, Sharify S, Fakhari Z, Sarafraz H, Aria A, Rasouli O. Effects of combining diaphragm training with electrical stimulation on pain, function, and balance in athletes with chronic low back pain: a randomized clinical trial. BMC Sports Sci Med Rehabil. 2021 Mar 4;13(1):20. doi: 10.1186/s13102-021-00250-y.
- Results publication: PubMed 38205226Masroor S, Tanwar T, Aldabbas M, Iram I, Veqar Z. Effect of Adding Diaphragmatic Breathing Exercises to Core Stabilization Exercises on Pain, Muscle Activity, Disability, and Sleep Quality in Patients With Chronic Low Back Pain: A Randomized Control Trial. J Chiropr Med. 2023 Dec;22(4):275-283. doi: 10.1016/j.jcm.2023.07.001. Epub 2023 Sep 2.
- Results publication: PubMed 32182226Oh YJ, Park SH, Lee MM. Comparison of Effects of Abdominal Draw-In Lumbar Stabilization Exercises with and without Respiratory Resistance on Women with Low Back Pain: A Randomized Controlled Trial. Med Sci Monit. 2020 Mar 17;26:e921295. doi: 10.12659/MSM.921295.
- Results publication: PubMed 27333481Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm Training and Myofascial Release Technique in people with Non Specific Low Back Pain, run by Rashid Latif Medical College at 1 site in Pakistan.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Sep 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 Pakistan. 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 was withdrawn before enrolling participants, so there are no results.
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 Level (time frame: Pre-intervention and 4 weeks Post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07167212, which also lists 5 linked publications.
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 18 Sep 2025.