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IRCT20240613062111N2 IRCT 2026-07-12 Babol University of Medical Sciences The Effect of Breathing Exercises and Diaphragm Release in Patients with Chronic Low Back Pain ندارد Comparison of the Effects of Diaphragm Release Technique and Breathing Exercises on Pain Intensity and Functional Disability in Patients with Chronic Non-Specific Low Back Pain 2026-07-11 anticipated 66 Recruiting https://irct.ir/trial/90226 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sample size of this study is 66 participants, who will be randomly allocated to two groups of 33 participants each (intervention and control). Block randomization will be used for participant allocation. The randomization sequence was generated by a methodologist using the Sealed Envelope website. A block size of 4 will be used. N/A Chronic Non_Specific Low Back Pain. Intervention 1: Intervention Group 1: All participants, irrespective of group allocation, will receive electrotherapy and lumbar stabilization exercises. For electrotherapy, participants will be positioned in side lying, and four electrodes will be placed bilaterally in a parallel arrangement over the lumbar paraspinal muscles. Acupuncture-like Transcutaneous Electrical Nerve Stimulation (AL-TENS) will be delivered at a frequency of 5 Hz to alleviate chronic low back pain. Electrotherapy will be administered for 20 minutes per treatment session. Lumbar stabilization exercise program: The program consists of exercises designed to retrain the activation and motor control of the deep trunk muscles and to improve coordination between the deep and superficial trunk muscles during static, dynamic, and functional activities. In addition to supervised sessions, participants will be instructed to perform the exercises at home twice daily. Each participant will receive an exercise logbook to record adherence to the home exercise program. Participants who fail to perform the exercises during two consecutive home sessions will be withdrawn from the study.Week 1: Activation of the Transversus Abdominis Muscle: Participants will be instructed to lie in the supine position with both knees flexed to 90°. To activate the transversus abdominis muscle, they will be asked to gently draw the lower abdominal wall (below the umbilicus) inward and upward without moving the rib cage, pelvis, or lumbar spine. The duration of the contraction will be gradually increased according to the participant's ability. Exercise progression will be permitted only when the participant is able to correctly activate the transversus abdominis muscle using a low-intensity contraction for 10 consecutive repetitions while maintaining proper technique. Week 2: Activation of the Multifidus Muscle: Participants will be instructed to sit upright on a chair. The therapist will palpate the lumbar paraspinal region and instruct the participant to simultaneously activate the transversus abdominis and multifidus muscles. Once appropriate muscle activation is confirmed by palpation, participants will be encouraged to palpate the same region themselves to enhance proprioceptive awareness. They will then be instructed to maintain the contraction for 10 seconds and perform 10 repetitions while breathing normally throughout the exercise. Week 3: Participants will be instructed to lie in the supine position with both knees flexed at 90°. While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to abduct one hip to approximately 45° and hold the position for 10 seconds. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement.Week 4: Participants will remain in the same position as in Week 3 (supine with both knees flexed at 90°). While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to slowly slide one heel along the treatment table until the knee is fully extended. The contraction will be maintained for 10 seconds, after which the leg will be returned to the starting position. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement. Specific Intervention for Group 1: Diaphragm Release Technique: The diaphragm release technique will be performed bilaterally at the costal, sternal, and lumbar attachments in two sets, each consisting of 10 deep breathing cycles (inspiration and expiration), with a 1-minute rest interval between sets. Participants will be positioned in the supine position while the therapist will place the hypothenar eminence and the last three fingers of both hands beneath the inferior costal margin. During inspiration, the therapist will gently follow the movement of the ribs in a superior and lateral direction. During expiration, contact will be maintained while the hands will be gradually directed toward the inner aspect of the costal margin to facilitate diaphragm release. The intervention will be administered three sessions per week for four weeks (12 sessions in total). Intervention 2: Intervention Group 2: All participants, irrespective of group allocation, will receive electrotherapy and lumbar stabilization exercises. For electrotherapy, participants will be positioned in side lying, and four electrodes will be placed bilaterally in a parallel arrangement over the lumbar paraspinal muscles. Acupuncture-like Transcutaneous Electrical Nerve Stimulation (AL-TENS) will be delivered at a frequency of 5 Hz to alleviate chronic low back pain. Electrotherapy will be administered for 20 minutes per treatment session. Lumbar stabilization exercise program: The program consists of exercises designed to retrain the activation and motor control of the deep trunk muscles and to improve coordination between the deep and superficial trunk muscles during static, dynamic, and functional activities. In addition to supervised sessions, participants will be instructed to perform the exercises at home twice daily. Each participant will receive an exercise logbook to record adherence to the home exercise program. Participants who fail to perform the exercises during two consecutive home sessions will be withdrawn from the study.Week 1: Activation of the Transversus Abdominis Muscle: Participants will be instructed to lie in the supine position with both knees flexed to 90°. To activate the transversus abdominis muscle, they will be asked to gently draw the lower abdominal wall (below the umbilicus) inward and upward without moving the rib cage, pelvis, or lumbar spine. The duration of the contraction will be gradually increased according to the participant's ability. Exercise progression will be permitted only when the participant is able to correctly activate the transversus abdominis muscle using a low-intensity contraction for 10 consecutive repetitions while maintaining proper technique. Week 2: Activation of the Multifidus Muscle: Participants will be instructed to sit upright on a chair. The therapist will palpate the lumbar paraspinal region and instruct the participant to simultaneously activate the transversus abdominis and multifidus muscles. Once appropriate muscle activation is confirmed by palpation, participants will be encouraged to palpate the same region themselves to enhance proprioceptive awareness. They will then be instructed to maintain the contraction for 10 seconds and perform 10 repetitions while breathing normally throughout the exercise. Week 3: Participants will be instructed to lie in the supine position with both knees flexed at 90°. While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to abduct one hip to approximately 45° and hold the position for 10 seconds. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement. Week 4: Participants will remain in the same position as in Week 3 (supine with both knees flexed at 90°). While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to slowly slide one heel along the treatment table until the knee is fully extended. The contraction will be maintained for 10 seconds, after which the leg will be returned to the starting position. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement. Specific Intervention for Group 2: Breathing Exercises: Breathing exercises will be performed only during the treatment sessions under the supervision of a physiotherapist. The intervention will be administered three sessions per week for four weeks (12 sessions in total). Week 1: Participants will be instructed to lie in the supine position on a firm surface or treatment table with both knees flexed. One hand will be placed on the chest and the other on the abdomen, just below the costal margin. Participants will be instructed to inhale slowly through the nose, directing the air toward the lower abdomen. The hand placed on the chest will be kept as still as possible, while the neck and shoulder muscles will remain relaxed. Simultaneously, the hand placed on the abdomen will rise as the abdomen expands. Participants will then be instructed to gently contract the abdominal muscles and exhale through pursed lips. During exhalation, the hand on the abdomen will gradually return to its initial position. The exercise will be performed for 10 repetitions during each treatment session. Week 2: Participants will remain in the same position as in Week 1. An elastic resistance band will be applied around the thoracolumbar region to provide resistance during diaphragmatic breathing. Participants will then perform diaphragmatic breathing as described in Week 1 for 10 repetitions during each treatment session. Week 3: Participants will be instructed to sit upright on a chair with the hips, knees, and ankles maintained at 90° of flexion. They will be instructed to sit as tall as possible, as if "a string attached to the top of the head were gently pulling them upward," while performing diaphragmatic breathing in the same manner as described in Week 1. The exercise will be performed for 10 repetitions during each treatment session. Week 4: Participants will remain in the same sitting position as in Week 3. An elastic resistance band will be applied around the thoracolumbar region to provide resistance during diaphragmatic breathing. Participants will then perform diaphragmatic breathing as described in Week 3 for 10 repetitions during each treatment session. Yes - There is a plan to make this available What will be shared: Data on primary outcomes, confounding variables, and demographic characteristics will be shared in a de-identified format to ensure participant anonymity. When: Access to the data will begin after the study results are published. To whom: Researchers working in the relevant field. Conditions: Data from this study will be available for inclusion in systematic reviews. Where to obtain: Requests for access to the data should be sent by email to the Principal Investigator, Dr. Maryam Abbaszadeh, at m.abbaszadeh@mubabol.ac.ir. How to obtain: Upon receipt of a data request, the Principal Investigator will review the request, and if the applicant is deemed eligible, the requested data will be shared with the applicant. Comments:
public Maryam Abbaszadeh-Amirdehi
Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran
Babol Iran (Islamic Republic of) 4774547176 +98 11 3219 4941 m.abbaszadeh@mubabol.ac.ir Babol University of Medical Sciences scientific Maryam Abbaszadeh-Amirdehi
Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran
Babol Iran (Islamic Republic of) 4774547176 +98 11 3219 4941 m.abbaszadeh@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Individuals with pain located between the costal margin and the gluteal fold Individuals aged between 18 and 45 years Female participants Individuals with low back pain, with or without leg pain, for at least 3 months Individuals who have not received physiotherapy for the lumbar region during the past year Individuals with moderate pain intensity (pain score between 3 and 7) 18 years 45 years Female Individuals Exhibiting Signs of Spondylolisthesis Individuals with Systemic Infections Individuals with Respiratory Problems Individuals with Bowel and Bladder Issues Individuals who Are Pregnant Individuals Taking Psychotropic Medications Individuals Using Illicit Drugs Individuals with Alcohol Consumption Individuals with structural spinal pathologies, such as cauda equina syndrome M54.5 Low Back Pain Rehabilitation Rehabilitation Intervention Group 1: All participants, irrespective of group allocation, will receive electrotherapy and lumbar stabilization exercises. For electrotherapy, participants will be positioned in side lying, and four electrodes will be placed bilaterally in a parallel arrangement over the lumbar paraspinal muscles. Acupuncture-like Transcutaneous Electrical Nerve Stimulation (AL-TENS) will be delivered at a frequency of 5 Hz to alleviate chronic low back pain. Electrotherapy will be administered for 20 minutes per treatment session. Lumbar stabilization exercise program: The program consists of exercises designed to retrain the activation and motor control of the deep trunk muscles and to improve coordination between the deep and superficial trunk muscles during static, dynamic, and functional activities. In addition to supervised sessions, participants will be instructed to perform the exercises at home twice daily. Each participant will receive an exercise logbook to record adherence to the home exercise program. Participants who fail to perform the exercises during two consecutive home sessions will be withdrawn from the study.Week 1: Activation of the Transversus Abdominis Muscle: Participants will be instructed to lie in the supine position with both knees flexed to 90°. To activate the transversus abdominis muscle, they will be asked to gently draw the lower abdominal wall (below the umbilicus) inward and upward without moving the rib cage, pelvis, or lumbar spine. The duration of the contraction will be gradually increased according to the participant's ability. Exercise progression will be permitted only when the participant is able to correctly activate the transversus abdominis muscle using a low-intensity contraction for 10 consecutive repetitions while maintaining proper technique. Week 2: Activation of the Multifidus Muscle: Participants will be instructed to sit upright on a chair. The therapist will palpate the lumbar paraspinal region and instruct the participant to simultaneously activate the transversus abdominis and multifidus muscles. Once appropriate muscle activation is confirmed by palpation, participants will be encouraged to palpate the same region themselves to enhance proprioceptive awareness. They will then be instructed to maintain the contraction for 10 seconds and perform 10 repetitions while breathing normally throughout the exercise. Week 3: Participants will be instructed to lie in the supine position with both knees flexed at 90°. While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to abduct one hip to approximately 45° and hold the position for 10 seconds. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement.Week 4: Participants will remain in the same position as in Week 3 (supine with both knees flexed at 90°). While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to slowly slide one heel along the treatment table until the knee is fully extended. The contraction will be maintained for 10 seconds, after which the leg will be returned to the starting position. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement. Specific Intervention for Group 1: Diaphragm Release Technique: The diaphragm release technique will be performed bilaterally at the costal, sternal, and lumbar attachments in two sets, each consisting of 10 deep breathing cycles (inspiration and expiration), with a 1-minute rest interval between sets. Participants will be positioned in the supine position while the therapist will place the hypothenar eminence and the last three fingers of both hands beneath the inferior costal margin. During inspiration, the therapist will gently follow the movement of the ribs in a superior and lateral direction. During expiration, contact will be maintained while the hands will be gradually directed toward the inner aspect of the costal margin to facilitate diaphragm release. The intervention will be administered three sessions per week for four weeks (12 sessions in total). Intervention Group 2: All participants, irrespective of group allocation, will receive electrotherapy and lumbar stabilization exercises. For electrotherapy, participants will be positioned in side lying, and four electrodes will be placed bilaterally in a parallel arrangement over the lumbar paraspinal muscles. Acupuncture-like Transcutaneous Electrical Nerve Stimulation (AL-TENS) will be delivered at a frequency of 5 Hz to alleviate chronic low back pain. Electrotherapy will be administered for 20 minutes per treatment session. Lumbar stabilization exercise program: The program consists of exercises designed to retrain the activation and motor control of the deep trunk muscles and to improve coordination between the deep and superficial trunk muscles during static, dynamic, and functional activities. In addition to supervised sessions, participants will be instructed to perform the exercises at home twice daily. Each participant will receive an exercise logbook to record adherence to the home exercise program. Participants who fail to perform the exercises during two consecutive home sessions will be withdrawn from the study.Week 1: Activation of the Transversus Abdominis Muscle: Participants will be instructed to lie in the supine position with both knees flexed to 90°. To activate the transversus abdominis muscle, they will be asked to gently draw the lower abdominal wall (below the umbilicus) inward and upward without moving the rib cage, pelvis, or lumbar spine. The duration of the contraction will be gradually increased according to the participant's ability. Exercise progression will be permitted only when the participant is able to correctly activate the transversus abdominis muscle using a low-intensity contraction for 10 consecutive repetitions while maintaining proper technique. Week 2: Activation of the Multifidus Muscle: Participants will be instructed to sit upright on a chair. The therapist will palpate the lumbar paraspinal region and instruct the participant to simultaneously activate the transversus abdominis and multifidus muscles. Once appropriate muscle activation is confirmed by palpation, participants will be encouraged to palpate the same region themselves to enhance proprioceptive awareness. They will then be instructed to maintain the contraction for 10 seconds and perform 10 repetitions while breathing normally throughout the exercise. Week 3: Participants will be instructed to lie in the supine position with both knees flexed at 90°. While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to abduct one hip to approximately 45° and hold the position for 10 seconds. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement. Week 4: Participants will remain in the same position as in Week 3 (supine with both knees flexed at 90°). While maintaining simultaneous activation of the transversus abdominis and multifidus muscles, they will be instructed to slowly slide one heel along the treatment table until the knee is fully extended. The contraction will be maintained for 10 seconds, after which the leg will be returned to the starting position. The exercise will be performed for 10 repetitions on each side while maintaining proper muscle activation throughout the movement. Specific Intervention for Group 2: Breathing Exercises: Breathing exercises will be performed only during the treatment sessions under the supervision of a physiotherapist. The intervention will be administered three sessions per week for four weeks (12 sessions in total). Week 1: Participants will be instructed to lie in the supine position on a firm surface or treatment table with both knees flexed. One hand will be placed on the chest and the other on the abdomen, just below the costal margin. Participants will be instructed to inhale slowly through the nose, directing the air toward the lower abdomen. The hand placed on the chest will be kept as still as possible, while the neck and shoulder muscles will remain relaxed. Simultaneously, the hand placed on the abdomen will rise as the abdomen expands. Participants will then be instructed to gently contract the abdominal muscles and exhale through pursed lips. During exhalation, the hand on the abdomen will gradually return to its initial position. The exercise will be performed for 10 repetitions during each treatment session. Week 2: Participants will remain in the same position as in Week 1. An elastic resistance band will be applied around the thoracolumbar region to provide resistance during diaphragmatic breathing. Participants will then perform diaphragmatic breathing as described in Week 1 for 10 repetitions during each treatment session. Week 3: Participants will be instructed to sit upright on a chair with the hips, knees, and ankles maintained at 90° of flexion. They will be instructed to sit as tall as possible, as if "a string attached to the top of the head were gently pulling them upward," while performing diaphragmatic breathing in the same manner as described in Week 1. The exercise will be performed for 10 repetitions during each treatment session. Week 4: Participants will remain in the same sitting position as in Week 3. An elastic resistance band will be applied around the thoracolumbar region to provide resistance during diaphragmatic breathing. Participants will then perform diaphragmatic breathing as described in Week 3 for 10 repetitions during each treatment session. Pain Intensity. Timepoint: At baseline, at the end of week 2 (session 6), and at the end of week 4 (session 12). Method of measurement: Visual Analogue Scale. Functional Disability. Timepoint: At baseline, at the end of week 2 (session 6), and at the end of week 4 (session 12). Method of measurement: Roland Morris Disability Questionnaire. Chest Expansion. Timepoint: At baseline, at the end of week 2 (session 6), and at the end of week 4 (session 12). Method of measurement: Meter. Fear-avoidance. Timepoint: At baseline, at the end of week 2 (session 6), and at the end of week 4 (session 12). Method of measurement: Fear-avoidance Belief Questionnaire. Central Sensitization. Timepoint: At baseline, at the end of week 2 (session 6), and at the end of week 4 (session 12). Method of measurement: Central Sensitization Inventory Questionnaire. Babol University of Medical Sciences Approved 2026-04-21 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz Ave. Babol Mazandaran Iran (Islamic Republic of)