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

September 14, 2025 updated by: Aleena Waheed, Rashid Latif Medical College

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54900
        • Arif Memorial Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaphragm Training
Other: 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.
Active Comparator: Myofascial Release technique
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-intervention and 4 weeks Post-intervention
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.
Pre and 4 week post-intervention
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
Pre and 4 weeks Post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rashid Latif Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Actual)

March 24, 2025

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

September 1, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2024/213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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