Sacroiliac Joint DysfunctionNCT06442124
The Effect of BMI on Gluteus Maximum Activity in Adulthood With Sacroiliac Dysfunction
An observational study of Sacroiliac Joint Dysfunction and Obesity, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
PURPOSE: This study will be conducted to investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction BACKGROUND: Sacroiliac joint (SIJ) pain is pain arising from SIJ structures and SIJ dysfunction (SIJD) generally refers to aberrant position or movement of SIJ structures . Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Obesity, EMG
- What is being tested?
- Electromyography (EMG)
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2024to 30 Jun 2024
- Phase
- Observational
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects: A total of 60 male \& female subjects, diagnosed with sacroiliac dysfunction participated in this study. Their BMI will from 20- 30kg/m2.
Who may be able to join
- adulthood with sacroiliac dysfunction
- Their ages will range from 20-40 years old.
- Their BMI will be less than 20- 30kg/m2.
- All of them suffer from mild to moderate degree of sacroiliac pain.
- The subjects complain from sacroiliac pain for 1 month ago
Who cannot join
- Exclusion criteria were a history of any of the following condition:
- inflammatory diseases or any rheumatic disorders,
- a history of vertebral fractures
- surgical spinal fixation.
- •any neurological disorders like MS
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahram Canadian university
Giza, 12573
Mohamed Ahmed, lecturer, 01006794075, mohamed.ababa@acu.rdu.eg
About this study
PURPOSE:
This study will be conducted to investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction BACKGROUND: Sacroiliac joint (SIJ) pain is pain arising from SIJ structures and SIJ dysfunction (SIJD) generally refers to aberrant position or movement of SIJ structures . An estimated 15-30% of all low back pain cases are due to SIJ pain The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction
Read more
HYPOTHESES:
. •There will be no effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction
RESEARCH QUESTION:
- Do BMI has an effect on gluteus maximum activity in adulthood with sacroiliac dysfunction?
- Conditions
- Sacroiliac Joint Dysfunction, Obesity, EMG
- Being tested
- Electromyography (EMG)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography (EMG)Diagnostic test
The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity recorded by EMG in adulthood with sacroiliac dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Group (A): | o Group (A): will includes subjects with sacroiliac dysfunction and their body mass index < 25 Receives: Diagnostic Test: Electromyography (EMG) | |
| Group (B): | o Group (B): will includes subjects with sacroiliac dysfunction and their body mass index > 25. Receives: Diagnostic Test: Electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gluteus maximum muscle activity measured by Electromyography (EMG)
Measured: up to 8 weeks
weight and height will be combined to report BMI in kg/m^2)
Measured: up to 8 weeks
visual analogue scale for pain
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start12 May 2024
- Primary completion20 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ababa, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442124
- Sponsor's protocol ID
- P.T-REC-012/005149
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BMI on Gluteus Maximum Activity in Adulthood With Sacroiliac Dysfunction
- ClinicalTrials.gov ID
- NCT06442124
- Acronym / sponsor ID
- P.T-REC-012/005149
- Conditions
- Sacroiliac Joint Dysfunction, Obesity, EMG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Jun 2024 (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.
PURPOSE:
This study will be conducted to investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction BACKGROUND: Sacroiliac joint (SIJ) pain is pain arising from SIJ structures and SIJ dysfunction (SIJD) generally refers to aberrant position or movement of SIJ structures . An estimated 15-30% of all low back pain cases are due to SIJ pain The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction
HYPOTHESES:
. •There will be no effect of BMI on gluteus maximum activity in adulthood with sacroiliac dysfunction
RESEARCH QUESTION:
- Do BMI has an effect on gluteus maximum activity in adulthood with sacroiliac dysfunction?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A): | – | Diagnostic Test: Electromyography (EMG)o Group (A): will includes subjects with sacroiliac dysfunction and their body mass index < 25 |
| Group (B): | – | Diagnostic Test: Electromyography (EMG)o Group (B): will includes subjects with sacroiliac dysfunction and their body mass index > 25. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects: A total of 60 male \& female subjects, diagnosed with sacroiliac dysfunction participated in this study. Their BMI will from 20- 30kg/m2.
Key inclusion criteria (5 listed)
- adulthood with sacroiliac dysfunction
- Their ages will range from 20-40 years old.
- Their BMI will be less than 20- 30kg/m2.
- All of them suffer from mild to moderate degree of sacroiliac pain.
- The subjects complain from sacroiliac pain for 1 month ago
Key exclusion criteria (5 listed)
- Exclusion criteria were a history of any of the following condition:
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 |
|---|---|---|
| Electromyography (EMG)The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will investigate the effect of BMI on gluteus maximum activity recorded by EMG in adulthood with sacroiliac dysfunction | Diagnostic test | Group (A):, Group (B): |
Primary outcome
gluteus maximum muscle activity measured by Electromyography (EMG)
Time frame: up to 8 weeks
weight and height will be combined to report BMI in kg/m^2)
Time frame: up to 8 weeks
visual analogue scale for pain
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction and Obesity, run by Ahram Canadian 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 5 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 4 Jun 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gluteus maximum muscle activity measured by Electromyography (EMG) (time frame: up to 8 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?
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 4 Jun 2024.