Sacroiliac Joint DysfunctionNCT05809206
Gluteus Maximus Versus Gluteus Medius Strength On Back Muscles Performance In Patients With Sacroiliac Dysfunction
A study testing Glutes maximus strength protocol, Gluteus medius strength program and Corrective Exercises in people with Sacroiliac Joint Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare between the effect of glutes maximus and glutes medius muscles strength on back muscle performance in patients with Sacroiliac joint dysfunction. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Glutes maximus strength protocol, Gluteus medius strength program and Corrective Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 15 Aug 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 25-40 years.
- Patients with chronic lumbopelvic pain (more than 12 weeks) and clinical test positive for SIJD.
- The pain distribution and tenderness on palpation under the posterior superior iliac spine (PSIS) are reliable signs that the SIJ is the source of pain.
- Complaint of unilateral pain rather than bilateral pain is also considered more likely to be coming from an SIJ.
- Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.
Who cannot join
- Neurological disorder, psychosomatic disorder
- Tumor.
- Infection condition.
- Recent surgeries.
- Pregnancy.
- Back pain referred from organic cause.
- Osteoporosis and bone disease (induced or idiopathic).
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to compare between the effect of glutes maximus and glutes medius muscles strength on back muscle performance in patients with Sacroiliac joint dysfunction.
Read the detailed description
The purposes of this study are:
- To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back pain in patient with Sacroiliac joint dysfunction
- To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back muscle performance in patients with Sacroiliac joint dysfunction
- To investigate the effects of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on function in patient with Sacroiliac joint Dysfunction
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Glutes maximus strength protocol, Gluteus medius strength program, Corrective Exercises, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutes maximus strength protocolOther
The subjects attended physical therapy two times. Per week for a total of 10 visits. Each session lasted approximately 30 minutes. In the first five sessions, subjects performed the following exercises to strengthen the gluteus maximus: bilateral bridge, unilateral bridge, and non-weight-bearing hip extension in prone with the knee flexed at 90 degrees. In the next five sessions, abduction and external rotation in a quadruped ("fire hydrant" exercise) and weight-bearing hip extension (known as "deadlift" exercise) were added. Each exercise was performed for 10 repetitions. Elastic resistance was added to the fire hydrant, hip extension in prone and dead lift exercises to allow each subject to perform at a 10-repetition maximum. The resistance for each subject was adjusted weekly as needed. The exercise program was performed under direct supervision only during the physical therapy sessions.
Gluteus medius strength programOther
Strengthening exercises for Gluteus Medius subdivisions:
The anterior GMED exercise: side lying abduction exercise The middle GMED exercise: wall press Exercise The posterior GMED exercise: was the pelvic drop exercise
Corrective ExercisesOther
The following low back corrective exercises were given:
To stretch the tight lower back muscles: Seated Forward Bend and Full Squat held for 5 sec and Repeated for 3 times, once a day.
To strengthen the weak lower abdomen: Draw in and Reverse Crunch 3 seconds, repeated 5 times, once a day.
To stretch the tight hip flexors: held for 10-15 seconds repeated 5 times on both legs, once a day.
To stretch the tight quadriceps: held for 3 seconds, repeated 5 times on each side, once a day.
To strengthen weak hamstrings: Kick Butts 2 sec, repeated 8 times, once a day.
UltrasoundDevice
US was administered in continuous mode at PSIS with patient in prone lying position, with a frequency of 1 MHz and intensity of 0.8 W/cm2 for 5 minutes every alternating day
| Study group | Role | What they receive |
|---|---|---|
| Glutes maximus Strengthening group | Experimental | Twenty patients received Strengthening exercises for Glutes maximus muscle and conventional physical therapy (corrective exercises and ultrasound). Receives: Other: Glutes maximus strength protocol; Other: Corrective Exercises; Device: Ultrasound |
| Glutes Medius Strengthening group | Experimental | Twenty patients received Strengthening exercises for Glutes medius muscle and conventional physical therapy (corrective Exercises and therapeutic ultrasound (US). Receives: Other: Gluteus medius strength program; Other: Corrective Exercises; Device: Ultrasound |
| Conventional treatment group | Active comparator | Twenty Patients received conventional therapy (corrective exercises and ultrasound). Receives: Other: Corrective Exercises; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in the peak torque of back muscles
By using isokinetic dynamometer, and the unit of of measurement will be (Kg).
Measured: at baseline and after 5 weeks of intervention
Assessing the change in pain threshold
by using Traditional pressure algometers are ideal for measuring pressure pain threshold (PPTs) of superficial muscles and bony landmarks. Pressure pain threshold has been defined as the lowest stimulus intensity at which a subject perceives mechanical pain
Measured: at baseline and after 5 weeks of intervention
Assessing the change in Functional ability level
By using Modified Oswestry Disability Questionnaire (MODQ). The Oswestry Low Back Pain Disability Questionnaire Arabic version will be used to measure disability caused by low back pain in the general population. It consists of 10 questions each consisting of six alternatives. Every question is scored from 0-5 and a percentage are formulated as a result of the sum of the scores.
Measured: at baseline and after 5 weeks of intervention
Assessing the change in pain intensity
By using visual analogue scale (VAS). This scale will be used to measure the intensity of pain. It has been graded as a 10-cm line, which was used for measuring the intensity of perceived pain. In this scale, zero represents the absence of pain, 1-3 shows mild pain, 4-6 denotes moderate pain, and 7-10 indicates severe pain
Measured: at baseline and after 5 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start10 Apr 2023 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Abd El moneim Mahmoud Gomma, Cairo University
- Investigators
- Reham Abd El-Moneim, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809206
- Sponsor's protocol ID
- Reham_Gomma_PhD
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluteus Maximus Versus Gluteus Medius Strength On Back Muscles Performance In Patients With Sacroiliac Dysfunction
- ClinicalTrials.gov ID
- NCT05809206
- Acronym / sponsor ID
- Reham_Gomma_PhD
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 12 Apr 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.
This study will be conducted to compare between the effect of glutes maximus and glutes medius muscles strength on back muscle performance in patients with Sacroiliac joint dysfunction.
Detailed description
The purposes of this study are:
- To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back pain in patient with Sacroiliac joint dysfunction
- To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back muscle performance in patients with Sacroiliac joint dysfunction
- To investigate the effects of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on function in patient with Sacroiliac joint Dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glutes maximus Strengthening group | Experimental | Other: Glutes maximus strength protocol, Other: Corrective Exercises, Device: UltrasoundTwenty patients received Strengthening exercises for Glutes maximus muscle and conventional physical therapy (corrective exercises and ultrasound). |
| Glutes Medius Strengthening group | Experimental | Other: Gluteus medius strength program, Other: Corrective Exercises, Device: UltrasoundTwenty patients received Strengthening exercises for Glutes medius muscle and conventional physical therapy (corrective Exercises and therapeutic ultrasound (US). |
| Conventional treatment group | Active comparator | Other: Corrective Exercises, Device: UltrasoundTwenty Patients received conventional therapy (corrective exercises and ultrasound). |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 25-40 years.
- Patients with chronic lumbopelvic pain (more than 12 weeks) and clinical test positive for SIJD.
- The pain distribution and tenderness on palpation under the posterior superior iliac spine (PSIS) are reliable signs that the SIJ is the source of pain.
- Complaint of unilateral pain rather than bilateral pain is also considered more likely to be coming from an SIJ.
- Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.
Key exclusion criteria (7 listed)
- Neurological disorder, psychosomatic disorder
- Tumor.
- Infection condition.
- Recent surgeries.
- Pregnancy.
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 |
|---|---|---|
| Glutes maximus strength protocolThe subjects attended physical therapy two times. Per week for a total of 10 visits. Each session lasted approximately 30 minutes. In the first five sessions, subjects performed the following exercises to strengthen the gluteus maximus: bilateral bridge, unilateral bridge, and non-weight-bearing hip extension in prone with the knee flexed at 90 degrees. In the next five sessions, abduction and external rotation in a quadruped ("fire hydrant" exercise) and weight-bearing hip extension (known as "deadlift" exercise) were added. Each exercise was performed for 10 repetitions. Elastic resistance was added to the fire hydrant, hip extension in prone and dead lift exercises to allow each subject to perform at a 10-repetition maximum. The resistance for each subject was adjusted weekly as needed. The exercise program was performed under direct supervision only during the physical therapy sessions. | Other | Glutes maximus Strengthening group |
| Gluteus medius strength programStrengthening exercises for Gluteus Medius subdivisions: The anterior GMED exercise: side lying abduction exercise The middle GMED exercise: wall press Exercise The posterior GMED exercise: was the pelvic drop exercise | Other | Glutes Medius Strengthening group |
| Corrective ExercisesThe following low back corrective exercises were given: To stretch the tight lower back muscles: Seated Forward Bend and Full Squat held for 5 sec and Repeated for 3 times, once a day. To strengthen the weak lower abdomen: Draw in and Reverse Crunch 3 seconds, repeated 5 times, once a day. To stretch the tight hip flexors: held for 10-15 seconds repeated 5 times on both legs, once a day. To stretch the tight quadriceps: held for 3 seconds, repeated 5 times on each side, once a day. To strengthen weak hamstrings: Kick Butts 2 sec, repeated 8 times, once a day. | Other | Conventional treatment group, Glutes Medius Strengthening group, Glutes maximus Strengthening group |
| UltrasoundUS was administered in continuous mode at PSIS with patient in prone lying position, with a frequency of 1 MHz and intensity of 0.8 W/cm2 for 5 minutes every alternating day | Device | Conventional treatment group, Glutes Medius Strengthening group, Glutes maximus Strengthening group |
Primary outcome
Assessing the change in the peak torque of back muscles
Time frame: at baseline and after 5 weeks of intervention
By using isokinetic dynamometer, and the unit of of measurement will be (Kg).
Assessing the change in pain threshold
Time frame: at baseline and after 5 weeks of intervention
by using Traditional pressure algometers are ideal for measuring pressure pain threshold (PPTs) of superficial muscles and bony landmarks. Pressure pain threshold has been defined as the lowest stimulus intensity at which a subject perceives mechanical pain
Assessing the change in Functional ability level
Time frame: at baseline and after 5 weeks of intervention
By using Modified Oswestry Disability Questionnaire (MODQ). The Oswestry Low Back Pain Disability Questionnaire Arabic version will be used to measure disability caused by low back pain in the general population. It consists of 10 questions each consisting of six alternatives. Every question is scored from 0-5 and a percentage are formulated as a result of the sum of the scores.
Assessing the change in pain intensity
Time frame: at baseline and after 5 weeks of intervention
By using visual analogue scale (VAS). This scale will be used to measure the intensity of pain. It has been graded as a 10-cm line, which was used for measuring the intensity of perceived pain. In this scale, zero represents the absence of pain, 1-3 shows mild pain, 4-6 denotes moderate pain, and 7-10 indicates severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Reham Abd El-Moneim principal investigator
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 Glutes maximus strength protocol, Gluteus medius strength program and Corrective Exercises in people with Sacroiliac Joint Dysfunction, 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: status not confirmed, as of the sponsor's last update on 12 Apr 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 Reham Abd El-Moneim (+201006722789, Rehamgomma.88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in the peak torque of back muscles (time frame: at baseline and after 5 weeks of intervention). The study lists 4 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 12 Apr 2023.