LumbarNCT07734909
Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
A study testing Diaphragm strengthening and Core stability exercises in people with Lumbar, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the effect of combining diaphragmatic strengthening with core stability exercises versus core stability exercises alone on recovery time, pain, and stability in lumbar instability individuals. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Lumbar
- What is being tested?
- Diaphragm strengthening and Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2026to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mona AbdelRaouf Moursy, PhD contact
Egypt1 site
Outpatient clinic of the faculty of physical therapy, Cairo University
Cairo
Ahmed Hesham Abd El-Mawgoud, B.Sc, +20 11 20484750, ahmed.hesham.hassona@gmail.com
About this study
The purpose of this study is to compare the effect of combining diaphragmatic strengthening with core stability exercises versus core stability exercises alone on recovery time, pain, and stability in lumbar instability individuals.
Read the 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.
- Conditions
- Lumbar
- Being tested
- Diaphragm strengthening, Core stability exercises
- Keywords
- Diaphragm, Core, lumbar instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm strengtheningOther
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).
Core stability exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined diaphragm strengthening + Core stability exercises | Experimental | 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. Receives: Other: Diaphragm strengthening; Other: Core stability exercises |
| Core stability exercises | Active comparator | 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. Receives: Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed using the Visual Analogue Scale (VAS)
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.
Measured: 8 weeks
Pressure pain threshold assessed by pressure algometry
Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer. Higher values indicate reduced pain sensitivity.
Measured: 8 weeks
Secondary outcomes (2)
Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
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.
Measured: 8 weeks
Functional disability assessed using the Oswestry Disability Index (ODI)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start5 Aug 2026 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LumbarStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hesham abd el-Mawgoud, Cairo University
- Investigators
- Ahmad Mahdi Ahmad, PhD, Study chair, Professor, Cairo UniversityMaged Mohamed Samy Abouelsoud, PhD, Study director, Professor, Ain Shams UniversityMona AbdelRaouf Moursy, Study director, Assist. Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734909
- Sponsor's protocol ID
- P.T.REC/012/006064
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Diaphragm Strengthening and Core Stability Exercises in Individuals With Lumbar Instability
- ClinicalTrials.gov ID
- NCT07734909
- Acronym / sponsor ID
- P.T.REC/012/006064
- Conditions
- Lumbar
- Keywords
- Diaphragm, Core, lumbar instability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 29 Jul 2026 (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.
The purpose of this study is to compare the effect of combining diaphragmatic strengthening with core stability exercises versus core stability exercises alone on recovery time, pain, and stability in lumbar instability individuals.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined diaphragm strengthening + Core stability exercises | Experimental | Other: Diaphragm strengthening, Other: Core stability exercisesIt 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. |
| Core stability exercises | Active comparator | Other: Core stability exercisesIt will include patients that will perform core stability exercises alone. The treatment program will be 45 minutes, 3 times a week, for 8 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
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 strengtheningParticipants 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). | Other | Combined diaphragm strengthening + Core stability exercises |
| Core stability exercisesParticipants 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. | Other | Combined diaphragm strengthening + Core stability exercises, Core stability exercises |
Primary outcome
Pain intensity assessed using the Visual Analogue Scale (VAS)
Time frame: 8 weeks
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.
Pressure pain threshold assessed by pressure algometry
Time frame: 8 weeks
Pressure pain threshold will be measured over the lumbar paraspinal muscles using a handheld pressure algometer. Higher values indicate reduced pain sensitivity.
2 secondary outcomes
Core muscle stability assessed using a Pressure Biofeedback Unit (PBU)
Time frame: 8 weeks
Functional disability assessed using the Oswestry Disability Index (ODI)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
Mona AbdelRaouf Moursy, PhD contact
Ahmad Mahdi Ahmad, PhD study chair
Professor, Cairo University
Maged Mohamed Samy Abouelsoud, PhD study director
Professor, Ain Shams University
Mona AbdelRaouf Moursy study director
Assist. Professor, Cairo University
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 strengthening and Core stability exercises in people with Lumbar, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hesham Abd El-Mawgoud, B.Sc (+20 11 20484750, ahmed.hesham.hassona@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed using the Visual Analogue Scale (VAS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.