- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07734909
Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lumbar instability is a common medical problem. There is a 50-70% chance of a person suffering from LBP during his or her lifetime having lumbar instability. It is often referred to as clinical spinal instability. Clinical spinal instability is controversial and poorly understood. Properly conducted clinical studies of patients with spinal pain and documented clinical instability would be good to explore this concept. However, pursuing such a course is difficult.
The diaphragm has a dual role in respiration and postural control. Evidence suggests that current core stability exercises for low back pain are superior to minimal or no treatment, however, no more beneficial than general exercises and/or manual therapy. There appears to be a higher focus on the transverses abdominis and multifidi muscles and minimal attention to the diaphragm.
We propose that any form of core stabilization exercises for low back pain rehabilitation should consider the diaphragm. Core stabilization program could commence with facilitation of normal breathing patterns and progressive systematic restoration of the postural control role of the diaphragm muscle.
So, the aim of this trial is to determine whether combining diaphragmatic strengthening exercises with core stability training leads to faster improvements in pain and instability in individuals with lumbar instability, compared to traditional core exercises alone.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Hesham Abd El-Mawgoud, B.Sc
- Phone Number: +20 11 20484750
- Email: ahmed.hesham.hassona@gmail.com
Study Contact Backup
- Name: Mona AbdelRaouf Moursy, PhD
Study Locations
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Cairo, Egypt
- Outpatient clinic of the faculty of physical therapy, Cairo University
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Contact:
- Ahmed Hesham Abd El-Mawgoud, B.Sc
- Phone Number: +20 11 20484750
- Email: ahmed.hesham.hassona@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 25 and 35 years.
- Positive prone instability test.
- Straight leg raising >90 degrees.
- Pain assessment on VAS >5/10.
- All patients will suffer from clinical lumber instability (characterized by excessive movement in specific segments during active movement and posterior-anterior spring test causing large movements and pain)
Exclusion Criteria:
- Patients with cardiovascular diseases.
- Patients with cerebrovascular diseases.
- Patients with neurological diseases.
- Patients with any attention disorders or physical disability.
- Patients with any diseases/conditions preventing physical activity participation.
- Patients with history of back surgery, inflammatory spinal disorder, deformed vertebrae, fracture, or neurological radiating pain.
- Patients with central obesity (A waist to hip ratio >0.90 in males or > 0.85 in females).
Study Plan
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 |
|---|---|
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Experimental: Combined diaphragm strengthening + Core stability exercises
It will include patients that will perform combined diaphragm strengthening and core stability exercises.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
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Participants will receive supervised diaphragm strengthening exercises combined with core stability training, three sessions per week for 8 weeks (45 minutes/session).
Diaphragm strengthening will be performed using an elastic TheraBand wrapped around the thoracolumbar junction to provide progressive inspiratory resistance, with intensity progressed according to the Borg Rating of Perceived Exertion (RPE: 11 during weeks 1-2, 13 during weeks 3-5, and 15 during weeks 6-8).
Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
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Active Comparator: Core stability exercises
It will include patients that will perform core stability exercises alone.
The treatment program will be 45 minutes, 3 times a week, for 8 weeks.
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Participants will receive supervised core stability exercises only, three sessions per week for 8 weeks (45 minutes/session).
The exercise program includes the abdominal drawing-in maneuver (ADIM), side-bridge, and quadruped exercises, with progressive increases in exercise difficulty every two weeks.
Participants will perform the same exercise progression as the intervention group but without diaphragm strengthening or TheraBand resistance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity assessed using the Visual Analogue Scale (VAS)
Time Frame: 8 weeks
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Pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
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8 weeks
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Pressure pain threshold assessed by pressure algometry
Time Frame: 8 weeks
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Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer.
Higher values indicate reduced pain sensitivity.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
Time Frame: 8 weeks
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Core muscle stability will be assessed using a Pressure Biofeedback Unit during abdominal drawing-in tasks.
Improved pressure control indicates better activation of the local stabilizing muscles.
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8 weeks
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Functional disability assessed using the Oswestry Disability Index (ODI)
Time Frame: 8 weeks
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Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
Scores range from 0 to 100%, with higher scores indicating greater disability.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmad Mahdi Ahmad, PhD, Professor, Cairo University
- Study Director: Maged Mohamed Samy Abouelsoud, PhD, Professor, Ain Shams University
- Study Director: Mona AbdelRaouf Moursy, Assist. Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/006064
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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