Comparative Effect of Diaphragmatic Training in Patients With Chronic Non-specific Low Back Pain

NCT ID: NCT07167212

Last Updated: 2025-09-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2025-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Specific Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diaphragm Training

Diaphragm Training

Group Type EXPERIMENTAL

Diaphragm Training

Intervention Type OTHER

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 technique

Myofascial Release technique

Group Type ACTIVE_COMPARATOR

Myofascial Release Technique

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diaphragm Training

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.

Intervention Type OTHER

Myofascial Release Technique

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* lumbar surgery experience,
* inflammatory spinal disease,
* spinal deformities,
* neurologic radiating pain
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rashid Latif Medical College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aleena Waheed

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arif Memorial Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36775506 (View on PubMed)

Otadi 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.

Reference Type BACKGROUND
PMID: 33663607 (View on PubMed)

Masroor 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.

Reference Type BACKGROUND
PMID: 38205226 (View on PubMed)

Oh 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.

Reference Type BACKGROUND
PMID: 32182226 (View on PubMed)

Gonzalez-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.

Reference Type BACKGROUND
PMID: 27333481 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB/2024/213

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.