Lumbosacral InstabilityNCT05848479
Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women
A study testing Abdominal bracing and clamshell exercise in people with Lumbosacral Instability and Low Back Pain Post Partum, run by Eman Mahmoud Mahmoud El-sayed Ellily.
Trial summary
This study will be conducted on 44 females with postpartum LBP \& pelvic instability, selected from Dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Lumbosacral Instability, Low Back Pain Post Partum
- What is being tested?
- Abdominal bracing and clamshell exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2023to 26 Jul 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-partum females complaining of LBP and lumber instability
- Their age will be ranged from 25-35 years.
- Their BMI will be ranged from 25-30 kg/m2
Who cannot join
- Spinal deformity.
- Lower limb deformity.
- Osteosarcoma
- Mental disorders. 5-25>BMI>30
- 6-Performing any physical exercise at the time of the study. 7-Bad general Health
Trial locations and contacts
No sites are listed yet.
About this study
This study will be conducted on 44 females with postpartum LBP \& pelvic instability, selected from Dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women.
- Conditions
- Lumbosacral Instability, Low Back Pain Post Partum
- Being tested
- Abdominal bracing, clamshell exercise
- Keywords
- clamshell exercise, lumbopelvic instability, low back pain, post partum
- 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.
Abdominal bracingOther
they will perform 3 times/week of static abdominal contraction for six weeks.
clamshell exerciseOther
Each women will be positioned in side lying on the floor, with the pelvis and the spine in neutral position, the hips will bent at 45° and the knees flexed to 90°. She will abduct the top knee as far as possible, while keeping the heels together, then return to the starting position , the position will be maintained for 5 seconds in an abduction state, and repeated 10 times, with rest for 1 minute to minimize muscle fatigue,they will perform 3 times/week fo 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Abdominal bracing Receives: Other: Abdominal bracing |
| study group | Active comparator | Abdominal bracing and clamshell exercise Receives: Other: Abdominal bracing; Other: clamshell exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the degree of lumbopelvic instability
Change in the degree of lumbopelvic instability will be measured by specific tests(The dip test, the runner pose test and the single leg squat test) and the pateint performance will be graded as poor or good
Measured: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
lumbopelvic range of motion
Degree of lumbopelvic range of motion will be measured by goniometer
Measured: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
Secondary outcomes (2)
severity of pain intensity
change in low back pain intensity will be measured using visual analogue scale(VAS)
low back pain intensity
Measured: change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
the degree of function disability
the change in the degree of function disability will be measured by Oswestry disability index (ODI)
Measured: change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start26 May 2023 (estimated)
- Primary completion26 Jul 2023 (estimated)
- Study completion26 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral InstabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Mahmoud Mahmoud El-sayed Ellily
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Mahmoud Mahmoud El-sayed Ellily, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848479
- Sponsor's protocol ID
- P.T.REC/012/004341
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women
- ClinicalTrials.gov ID
- NCT05848479
- Acronym / sponsor ID
- P.T.REC/012/004341
- Conditions
- Lumbosacral Instability, Low Back Pain Post Partum
- Keywords
- clamshell exercise, lumbopelvic instability, low back pain, post partum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Eman Mahmoud Mahmoud El-sayed EllilyUniversity, hospital or other
- Study start
- 26 May 2023 (estimated)
- Primary completion
- 26 Jul 2023 (estimated)
- Study completion
- 26 Jul 2023 (estimated)
- First posted
- 8 May 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 on 44 females with postpartum LBP \& pelvic instability, selected from Dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Abdominal bracingAbdominal bracing |
| study group | Active comparator | Other: Abdominal bracing, Other: clamshell exerciseAbdominal bracing and clamshell exercise |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post-partum females complaining of LBP and lumber instability
- Their age will be ranged from 25-35 years.
- Their BMI will be ranged from 25-30 kg/m2
Key exclusion criteria (5 listed)
- Spinal deformity.
- Lower limb deformity.
- Osteosarcoma
- Mental disorders. 5-25>BMI>30
- 6-Performing any physical exercise at the time of the study. 7-Bad general Health
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 |
|---|---|---|
| Abdominal bracingthey will perform 3 times/week of static abdominal contraction for six weeks. | Other | control group, study group |
| clamshell exerciseEach women will be positioned in side lying on the floor, with the pelvis and the spine in neutral position, the hips will bent at 45° and the knees flexed to 90°. She will abduct the top knee as far as possible, while keeping the heels together, then return to the starting position , the position will be maintained for 5 seconds in an abduction state, and repeated 10 times, with rest for 1 minute to minimize muscle fatigue,they will perform 3 times/week fo 6 weeks | Other | study group |
Primary outcome
Change in the degree of lumbopelvic instability
Time frame: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
Change in the degree of lumbopelvic instability will be measured by specific tests(The dip test, the runner pose test and the single leg squat test) and the pateint performance will be graded as poor or good
lumbopelvic range of motion
Time frame: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
Degree of lumbopelvic range of motion will be measured by goniometer
2 secondary outcomes
severity of pain intensity
Time frame: change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
the degree of function disability
Time frame: change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal bracing and clamshell exercise in people with Lumbosacral Instability and Low Back Pain Post Partum, run by Eman Mahmoud Mahmoud El-sayed Ellily.
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 3 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 9 May 2023. 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 Eman M Mahmoud (+ 2 1091403074, amira.mahmoud2021@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the degree of lumbopelvic instability (time frame: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions). 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 9 May 2023.