Gluteus Medius, Ultrasonography, NSCLBPNCT05521165
Gluteus Medius Strengthening n Non Specific Chronic Low Back Pain
A study testing therapeutic exercises in people with Gluteus Medius, Ultrasonography, NSCLBP, run by Cairo University.
Trial summary
To study the effect of adding selected G Med muscle strengthening exercises to the APTA-guided program on pain, disability level, and G Med macromorphology in patients with NSCLBP. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Gluteus Medius, Ultrasonography, NSCLBP
- What is being tested?
- therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jan 2024
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients aged between 20-45yrs 2. Patients with NSCLBP (pain > 3 months). 3. NSCLBP must have been present for at least the previous 12 weeks. 4. Patients with unilateral or bilateral symptoms that are worse on one side than the other, are referred by an orthopedist.
Who cannot join
- 1. 'Red Flag' symptoms include, a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower extremity neurological deficit.
- 2. History of previous back surgery. 3. History of the previous pelvis or hip surgeries. 4. Recent or old fractures in lower limbs. 5. Cognitive impairment and inability to understand the scale. 6. Systemic inflammatory diseases e.g., rheumatoid arthritis and ankylosing spondylitis.
Trial locations and contacts
No sites are listed yet.
Mona Mo Ibrahim contact
About this study
Official title: Effect of Gluteus Medius Strengthening on Pain, Function, and Muscle Macromorphology in Nonspecific Chronic Low Back Pain
To study the effect of adding selected G Med muscle strengthening exercises to the APTA-guided program on pain, disability level, and G Med macromorphology in patients with NSCLBP.
Read the detailed description
Low back pain (LBP) is a significant global health problem. It occurs in all age groups from children to the elderly. Costs associated with health care and work disability attributed to LBP vary between countries and are influenced by social and health care approaches.
In almost all people with LBP, it is not possible to identify a specific cause. Only a small proportion of people have a well-understood pathological reason e.g., a vertebral fracture, malignancy, or infection. On the other hand, non-specific chronic low back pain (NSCLBP) accounts for about 85% of LBP patients treated in primary care, and the vast majority of patients with LBP seen by physical therapists are classified under this designation.
A recently published systematic review examined the impairment of lower extremity muscle strength in LBP disorders. The researchers reported a significant reduction in hip abductor, extensor, and knee extensor strength in patients with LBP compared to their healthy controls.
Researchers examined the strength of gluteus medius (G Med) muscle function in patients with LBP compared to non-LBP controls. The study reported that G Med muscle strength was decreased and several trigger points were developed but there were unclear results on fatigability, activity level, and macromorphology compared to healthy individuals.
It was evident, however, that the slight increase in muscle thickness of certain local and global muscles during contraction in the NSCLBP group compared to a healthy group when examined by ultrasonography could be an indicator that the strengthening of the multifidus, the transversus abdominis, and the G Med prevents the occurrence of LBP.
Exercise therapy is one of the inexpensive tools addressing pain relief and disability management in patients with subacute, chronic low back pain (CLBP) compared to usual care, according to the recently published systematic review.
Various types of exercise interventions should be used by physical therapists in the management of CLBP, as recommended by the American Physical Therapy Association (APTA) guidelines for clinical practice.
In a study by Mendis \& Hides (2016), they demonstrated lumbar-pelvic muscle imbalance in LBP and improvement in sartorius and G Med muscle size when motor training interventions were applied in non-weight-bearing and weight-bearing positions during treatment of LBP.
A recent study evaluated the effectiveness of adding specific hip strengthening exercises to a conventional rehabilitation program in the management of LBP patients. The results of the systematic review revealed that hip strengthening exercises could reduce pain and disability in these patients.
At the same time, there is still a knowledge gap regarding the effect of G Med strengthening exercise specifically on pain and disability levels in patients with NSCLBP and muscle macromorphology (thickness), as recommended in several recent systematic reviews.
- Conditions
- Gluteus Medius, Ultrasonography, NSCLBP
- Being tested
- therapeutic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercisesOther
strengthening exercises for gluteus medius and APTA guided program for NSCLBP
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | The patients in group (A) (n=29) will receive an American physical therapy association (APTA) guided program consisting of stretching exercises for global trunk, back muscles, and hamstring muscles, strengthening exercises for abdominal and back muscles, and stabilizing exercises for trunk and pelvic muscles. Receives: Other: therapeutic exercises |
| group B | Experimental | The patients in group (B) (n=29) will receive treatment as in group (A) in addition to selected G Med strengthening exercises. Receives: Other: therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
back Pain intensity level
The Numerical Pain Rating Scale (NPRS) for pain is a one-dimensional measure of pain intensity.
Measured: 6 weeks
disability level of low back pain patients
Back pain related disability is estimated using the cross-culturally adapted Arabic version of Oswestry disability index (ODI-AR).
Measured: 6 weeks
G Med macromorphology
measuring gluteus medius thickness by ultrasonography
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gluteus Medius, Ultrasonography, NSCLBPStudies 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
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadil Mohamed Onsy Mohamed Salama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521165
- Sponsor's protocol ID
- Gluteus Medius in back pain
- Status last verified
- Aug 2022
- First submitted
- 27 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abe T, Loenneke JP, Thiebaud RS. Morphological and functional relationships with ultrasound measured muscle thickness of the lower extremity: a brief review. Ultrasound. 2015 Aug;23(3):166-73. doi: 10.1177/1742271X15587599. Epub 2015 May 29.
PubMed 27433253Aboufazeli M, Akbari M, Jamshidi AA, Jafarpisheh MS. Comparison of Selective Local and Global Muscle Thicknesses in Females with and without Chronic Low Back Pain. Ortop Traumatol Rehabil. 2018 Jun 27;20(3):197-204. doi: 10.5604/01.3001.0012.1473.
PubMed 30152768Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.
PubMed 25262247Amabile AH, Bolte JH, Richter SD. Atrophy of gluteus maximus among women with a history of chronic low back pain. PLoS One. 2017 Jul 17;12(7):e0177008. doi: 10.1371/journal.pone.0177008. eCollection 2017.
PubMed 28715424Ayotte NW, Stetts DM, Keenan G, Greenway EH. Electromyographical analysis of selected lower extremity muscles during 5 unilateral weight-bearing exercises. J Orthop Sports Phys Ther. 2007 Feb;37(2):48-55. doi: 10.2519/jospt.2007.2354.
PubMed 17366959Bernet BA, Peskura ET, Meyer ST, Bauch PC, Donaldson MB. The effects of hip-targeted physical therapy interventions on low back pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2019 Feb;39:91-100. doi: 10.1016/j.msksp.2018.11.016. Epub 2018 Dec 1.
PubMed 30553988Cooper NA, Scavo KM, Strickland KJ, Tipayamongkol N, Nicholson JD, Bewyer DC, Sluka KA. Prevalence of gluteus medius weakness in people with chronic low back pain compared to healthy controls. Eur Spine J. 2016 Apr;25(4):1258-65. doi: 10.1007/s00586-015-4027-6. Epub 2015 May 26.
PubMed 26006705de Jesus FLA, Fukuda TY, Souza C, Guimaraes J, Aquino L, Carvalho G, Powers C, Gomes-Neto M. Addition of specific hip strengthening exercises to conventional rehabilitation therapy for low back pain: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1368-1377. doi: 10.1177/0269215520941914. Epub 2020 Jul 21.
PubMed 32691625
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gluteus Medius Strengthening on Pain, Function, and Muscle Macromorphology in Nonspecific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05521165
- Acronym / sponsor ID
- Gluteus Medius in back pain
- Conditions
- Gluteus Medius, Ultrasonography, NSCLBP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 30 Aug 2022 (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.
To study the effect of adding selected G Med muscle strengthening exercises to the APTA-guided program on pain, disability level, and G Med macromorphology in patients with NSCLBP.
Detailed description
Low back pain (LBP) is a significant global health problem. It occurs in all age groups from children to the elderly. Costs associated with health care and work disability attributed to LBP vary between countries and are influenced by social and health care approaches.
In almost all people with LBP, it is not possible to identify a specific cause. Only a small proportion of people have a well-understood pathological reason e.g., a vertebral fracture, malignancy, or infection. On the other hand, non-specific chronic low back pain (NSCLBP) accounts for about 85% of LBP patients treated in primary care, and the vast majority of patients with LBP seen by physical therapists are classified under this designation.
A recently published systematic review examined the impairment of lower extremity muscle strength in LBP disorders. The researchers reported a significant reduction in hip abductor, extensor, and knee extensor strength in patients with LBP compared to their healthy controls.
Researchers examined the strength of gluteus medius (G Med) muscle function in patients with LBP compared to non-LBP controls. The study reported that G Med muscle strength was decreased and several trigger points were developed but there were unclear results on fatigability, activity level, and macromorphology compared to healthy individuals.
It was evident, however, that the slight increase in muscle thickness of certain local and global muscles during contraction in the NSCLBP group compared to a healthy group when examined by ultrasonography could be an indicator that the strengthening of the multifidus, the transversus abdominis, and the G Med prevents the occurrence of LBP.
Exercise therapy is one of the inexpensive tools addressing pain relief and disability management in patients with subacute, chronic low back pain (CLBP) compared to usual care, according to the recently published systematic review.
Various types of exercise interventions should be used by physical therapists in the management of CLBP, as recommended by the American Physical Therapy Association (APTA) guidelines for clinical practice.
In a study by Mendis \& Hides (2016), they demonstrated lumbar-pelvic muscle imbalance in LBP and improvement in sartorius and G Med muscle size when motor training interventions were applied in non-weight-bearing and weight-bearing positions during treatment of LBP.
A recent study evaluated the effectiveness of adding specific hip strengthening exercises to a conventional rehabilitation program in the management of LBP patients. The results of the systematic review revealed that hip strengthening exercises could reduce pain and disability in these patients.
At the same time, there is still a knowledge gap regarding the effect of G Med strengthening exercise specifically on pain and disability levels in patients with NSCLBP and muscle macromorphology (thickness), as recommended in several recent systematic reviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: therapeutic exercisesThe patients in group (A) (n=29) will receive an American physical therapy association (APTA) guided program consisting of stretching exercises for global trunk, back muscles, and hamstring muscles, strengthening exercises for abdominal and back muscles, and stabilizing exercises for trunk and pelvic muscles. |
| group B | Experimental | Other: therapeutic exercisesThe patients in group (B) (n=29) will receive treatment as in group (A) in addition to selected G Med strengthening exercises. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Patients aged between 20-45yrs 2. Patients with NSCLBP (pain > 3 months). 3. NSCLBP must have been present for at least the previous 12 weeks. 4. Patients with unilateral or bilateral symptoms that are worse on one side than the other, are referred by an orthopedist.
Key exclusion criteria (2 listed)
- 1. 'Red Flag' symptoms include, a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower extremity neurological deficit.
- 2. History of previous back surgery. 3. History of the previous pelvis or hip surgeries. 4. Recent or old fractures in lower limbs. 5. Cognitive impairment and inability to understand the scale. 6. Systemic inflammatory diseases e.g., rheumatoid arthritis and ankylosing spondylitis.
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 |
|---|---|---|
| therapeutic exercisesstrengthening exercises for gluteus medius and APTA guided program for NSCLBP | Other | group A, group B |
Primary outcome
back Pain intensity level
Time frame: 6 weeks
The Numerical Pain Rating Scale (NPRS) for pain is a one-dimensional measure of pain intensity.
disability level of low back pain patients
Time frame: 6 weeks
Back pain related disability is estimated using the cross-culturally adapted Arabic version of Oswestry disability index (ODI-AR).
G Med macromorphology
Time frame: 6 weeks
measuring gluteus medius thickness by ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 27433253Abe T, Loenneke JP, Thiebaud RS. Morphological and functional relationships with ultrasound measured muscle thickness of the lower extremity: a brief review. Ultrasound. 2015 Aug;23(3):166-73. doi: 10.1177/1742271X15587599. Epub 2015 May 29.
- Background: PubMed 30152768Aboufazeli M, Akbari M, Jamshidi AA, Jafarpisheh MS. Comparison of Selective Local and Global Muscle Thicknesses in Females with and without Chronic Low Back Pain. Ortop Traumatol Rehabil. 2018 Jun 27;20(3):197-204. doi: 10.5604/01.3001.0012.1473.
- Background: PubMed 25262247Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.
- Background: PubMed 28715424Amabile AH, Bolte JH, Richter SD. Atrophy of gluteus maximus among women with a history of chronic low back pain. PLoS One. 2017 Jul 17;12(7):e0177008. doi: 10.1371/journal.pone.0177008. eCollection 2017.
- Background: PubMed 17366959Ayotte NW, Stetts DM, Keenan G, Greenway EH. Electromyographical analysis of selected lower extremity muscles during 5 unilateral weight-bearing exercises. J Orthop Sports Phys Ther. 2007 Feb;37(2):48-55. doi: 10.2519/jospt.2007.2354.
- Background: PubMed 30553988Bernet BA, Peskura ET, Meyer ST, Bauch PC, Donaldson MB. The effects of hip-targeted physical therapy interventions on low back pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2019 Feb;39:91-100. doi: 10.1016/j.msksp.2018.11.016. Epub 2018 Dec 1.
- Background: PubMed 26006705Cooper NA, Scavo KM, Strickland KJ, Tipayamongkol N, Nicholson JD, Bewyer DC, Sluka KA. Prevalence of gluteus medius weakness in people with chronic low back pain compared to healthy controls. Eur Spine J. 2016 Apr;25(4):1258-65. doi: 10.1007/s00586-015-4027-6. Epub 2015 May 26.
- Background: PubMed 32691625de Jesus FLA, Fukuda TY, Souza C, Guimaraes J, Aquino L, Carvalho G, Powers C, Gomes-Neto M. Addition of specific hip strengthening exercises to conventional rehabilitation therapy for low back pain: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1368-1377. doi: 10.1177/0269215520941914. Epub 2020 Jul 21.
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.
Mona Mo Ibrahim contact
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercises in people with Gluteus Medius, Ultrasonography, NSCLBP, run by Cairo University.
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 1 inclusion and 2 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 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Hadil Mo Mohamed salama (01092755255, hadilmohamed71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
back Pain intensity level (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT05521165, which also lists 8 linked publications.
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 2 Sep 2022.