Low Back PainNCT05770986
Effect of Power's Program of Gluteus Maximus on LBP
A study testing Group A and Group B in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Low back pain (LBP) is highly prevalent that causes significant pain and disability. Core muscles are important for LBP. One of them is gluteus maximus, but effect of power's program for this muscle and its role in LBP is lacking in literature, so this study aims to study the effect of power's program of gluteus… Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sex.
- Age 21-45 years.
- Chronic mechanical liw back pain for more than 3 years.
- Body mass index 18.4-29.9 kg/m^2.
Who cannot join
- Back pain due to specific pathology.
- postoperative
- Trauma to lower quadrant with past 6 months.
- Radicular pain. Lumbar instability.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Central hospital of Alkhanka
Cairo
Enas Fawzy
About this study
Official title: Gluteus Maximus Training Using Power's Program in Chronic Mechanical Low Back Pain
Low back pain (LBP) is highly prevalent that causes significant pain and disability. Core muscles are important for LBP. One of them is gluteus maximus, but effect of power's program for this muscle and its role in LBP is lacking in literature, so this study aims to study the effect of power's program of gluteus maximus on LBP.
Read the detailed description
Chronic mechanical low back pain (CMLBP) is a common musculoskeletal dysfunction affecting 53% of Egyptian population and 1.4 to 20.0% worldwide.
which is a major social and economic burden. Patients with CMLBP experience time loss of work and recently became a workforce burden. Giving the fact that back pain is widely prevalent across Egyptian population and by addressing the functional deficits in those patients, Proper physical therapy intervention can help reducing such burden and improve over all work performance. The 'Powers Program' is a recent concept and it had been proven to be effective in improving lower extremity function and biomechanics. Up to the knowledge of the primary investigator, GMax strengthening using this program has not been conducted in patients with CMLBP. Studying this approach may benefit physical therapists by providing an evidence-based approach in treating patients with CMLBP through exercise therapy and improve functional performance of these patients therefore they can return to normal activities faster. Moreover, this study may benefit researchers interested in Gluteus maximus (GMax) muscle strength. We believe that this study may open up more rooms for future research to address such an important issue.
- Conditions
- Low Back Pain
- Being tested
- Group A, Group B
- Keywords
- Disability, Gluteus maximus, Low back pain, Power's program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called Power's Program
the patient must attain the goal repetitions (and holds when required) at one level before progressing to the next level. The principal investigator will provide extensive education to the patient while progressing through the program. Three resistance bands will be used through the exercise progression; yellow band (low resistance), green band (moderate resistance) to blue band (high resistance). The patient will progress to more advanced level if he/she can sustain the position with high resistance band (blue) for one minute with three isometric holds of each exercise on each limb. three sets for 10 repetitions will be performed) Phases 1-3 of the program are focused on GMax activation. Phases 4- 5 are focused on GMax strength, and the final three phases emphasize functional applications of the GMax during ballistic tasks.
Group BOther
Also called Control
Flexibility exercises of the back muscles: knee to chest stretch, bridging, stretching exercises for hip flexors, piriformis, adductors and hamstring will be performed, with a hold of position for 30 s and with repetitions (3-5 times). Static stretches will be held for 30 seconds to induce changes in flexibility and will be repeated for three sets. Three sessions of stretching per week will be performed b. Prone resisted hip extension 10 repetitions for two sets. c. Hot pack: for 10 minutes. d. TENS: The electrodes will be placed over the area of most severe pain for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( power's group) | Experimental | Patients will receive the eight phases of the power's program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). Receives: Other: Group A |
| Group B ( control) | Active comparator | Patients will receive a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of low back Pain
Using the Arabic version of visual analogue scale (VAS), the patient will mark on a 0-10 graphic rating scale in which the (0) value indicating no pain,
Measured: 1 year
Secondary outcomes (4)
Severity of low back disability
Arabic version of Oswestry Disability Index (ODI):
Participants will choose the best answer reflecting their condition in each domain of ODI.
Measured: 1 year
Gluteus maximus strength
GMax muscle strength assessment, the following procedure will be followed: Patient Position: prone with knee to be tested flexed to 90 degrees Clinician Position: mid-table on the side to be tested. Elbows in full extension and both hands fixed to stabilize the HHD. HHD Position: just proximal to the popliteal fossa of the limb to be tested Standard Command: "Go ahead, push-push push-push-push, and relax" Method of Testing: 2 trials of 5 second duration, isometric contraction.
Measured: 1year
Single limb triple hop test for distnace:
Description: The distance a patient will travel when 3 maximal forward hops will be performed in succession.
Measured: One year
Single-Limb Crossover Hop Test for Distance
Description: The distance a patient will travel in seconds when 3 maximal crossover forward hops are performed. Measurement method: The patient will stand on one limb, with the toes on the starting line. The patient will perform 3 consecutive maximal hops as far as possible forward and land on the same limb while alternately crossing over a 15-cm strip on the floor. The distance hopped will be measured (in centimeter) from the starting line to the point where the patient's heel landed after the third hop.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 May 2022
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Model description
- Eligible patients will be randomly allocated to an experimental and a control group as follow: Group A (n= 26) will receive the eight phases of the Powers program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). Group B (n= 26) will receive the same conventional treatment only.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaymaa Abdeldaiem Abdeldaiem Mohammed, Cairo University
- Investigators
- Enas Fawzy, Principal investigator, professor, department of physical Therapy for musculoskeletal disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770986
- Sponsor's protocol ID
- 012/003955
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdeldaiem AA, Youssef EF, Mahmoud NF, Abdelmegeed M. Impact of gluteus maximus-focused intervention using Powers' program on chronic mechanical low back pain: A randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Jan 20;18(1):84. doi: 10.1186/s13102-025-01475-x.
PubMed 41559808
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluteus Maximus Training Using Power's Program in Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05770986
- Acronym / sponsor ID
- 012/003955
- Conditions
- Low Back Pain
- Keywords
- Disability, Gluteus maximus, Low back pain, Power's program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 16 Mar 2023 (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.
Low back pain (LBP) is highly prevalent that causes significant pain and disability. Core muscles are important for LBP. One of them is gluteus maximus, but effect of power's program for this muscle and its role in LBP is lacking in literature, so this study aims to study the effect of power's program of gluteus maximus on LBP.
Detailed description
Chronic mechanical low back pain (CMLBP) is a common musculoskeletal dysfunction affecting 53% of Egyptian population and 1.4 to 20.0% worldwide.
which is a major social and economic burden. Patients with CMLBP experience time loss of work and recently became a workforce burden. Giving the fact that back pain is widely prevalent across Egyptian population and by addressing the functional deficits in those patients, Proper physical therapy intervention can help reducing such burden and improve over all work performance. The 'Powers Program' is a recent concept and it had been proven to be effective in improving lower extremity function and biomechanics. Up to the knowledge of the primary investigator, GMax strengthening using this program has not been conducted in patients with CMLBP. Studying this approach may benefit physical therapists by providing an evidence-based approach in treating patients with CMLBP through exercise therapy and improve functional performance of these patients therefore they can return to normal activities faster. Moreover, this study may benefit researchers interested in Gluteus maximus (GMax) muscle strength. We believe that this study may open up more rooms for future research to address such an important issue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomly allocated to an experimental and a control group as follow: Group A (n= 26) will receive the eight phases of the Powers program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). Group B (n= 26) will receive the same conventional treatment only.
| Arm | Type | Receives |
|---|---|---|
| Group A ( power's group) | Experimental | Other: Group APatients will receive the eight phases of the power's program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). |
| Group B ( control) | Active comparator | Other: Group BPatients will receive a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sex.
- Age 21-45 years.
- Chronic mechanical liw back pain for more than 3 years.
- Body mass index 18.4-29.9 kg/m^2.
Key exclusion criteria (4 listed)
- Back pain due to specific pathology.
- postoperative
- Trauma to lower quadrant with past 6 months.
- Radicular pain. Lumbar instability.
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 |
|---|---|---|
| Group AAlso: Power's Programthe patient must attain the goal repetitions (and holds when required) at one level before progressing to the next level. The principal investigator will provide extensive education to the patient while progressing through the program. Three resistance bands will be used through the exercise progression; yellow band (low resistance), green band (moderate resistance) to blue band (high resistance). The patient will progress to more advanced level if he/she can sustain the position with high resistance band (blue) for one minute with three isometric holds of each exercise on each limb. three sets for 10 repetitions will be performed) Phases 1-3 of the program are focused on GMax activation. Phases 4- 5 are focused on GMax strength, and the final three phases emphasize functional applications of the GMax during ballistic tasks. | Other | Group A ( power's group) |
| Group BAlso: ControlFlexibility exercises of the back muscles: knee to chest stretch, bridging, stretching exercises for hip flexors, piriformis, adductors and hamstring will be performed, with a hold of position for 30 s and with repetitions (3-5 times). Static stretches will be held for 30 seconds to induce changes in flexibility and will be repeated for three sets. Three sessions of stretching per week will be performed b. Prone resisted hip extension 10 repetitions for two sets. c. Hot pack: for 10 minutes. d. TENS: The electrodes will be placed over the area of most severe pain for 15 minutes. | Other | Group B ( control) |
Primary outcome
Severity of low back Pain
Time frame: 1 year
Using the Arabic version of visual analogue scale (VAS), the patient will mark on a 0-10 graphic rating scale in which the (0) value indicating no pain,
4 secondary outcomes
Severity of low back disability
Time frame: 1 year
Gluteus maximus strength
Time frame: 1year
Single limb triple hop test for distnace:
Time frame: One year
Single-Limb Crossover Hop Test for Distance
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 41559808Abdeldaiem AA, Youssef EF, Mahmoud NF, Abdelmegeed M. Impact of gluteus maximus-focused intervention using Powers' program on chronic mechanical low back pain: A randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Jan 20;18(1):84. doi: 10.1186/s13102-025-01475-x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Enas Fawzy principal investigator
professor, department of physical Therapy for musculoskeletal disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Low Back Pain, 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaymaa AA Mohammed (01096617838, alshaymaa.mohammed2012@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of low back Pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05770986, which also lists 1 linked publication.
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 16 Mar 2023.