Postpartum Sacroiliac Joint PainNCT06124365
Shock Wave and Core Exercises for Postpartum Sacroiliac Pain
A study testing Shock wave therapy and core stability exercises and core stability exercises only in people with Postpartum Sacroiliac Joint Pain, run by Cairo University.
Trial summary
Despite the high popularity and novelty of shock wave therapy (SWT), it is surprising that just one study has examined the effect of SWT on patients with SIJD and their functional ability following treatment by using subjective assessment tools like numeric rating scale (NRS) and limited by its small sample size and… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Postpartum Sacroiliac Joint Pain
- What is being tested?
- Shock wave therapy and core stability exercises and core stability exercises only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2023to 25 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- post-partum women diagnosed with SIJP with limitation of its movement referred from the orthopedist.
- Age is between 25-35 years old.
- Their body mass index will be ranged from 25-35 kg/m2.
Who cannot join
- Patients who have one of the following criteria will be excluded from the study:
- Previous spinal surgery.
- Medical diagnosis other than SIJ dysfunction.
- Patients who had any other spine disorders.
- Patients who had leg length discrepancies.
- Patients with congenital postural deformities.
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- Patients with spinal cord injury or acute or unstable neurological signs.
- Patients with cauda equina symptoms related to the spine including changes in bowel or bladder control and perineal sensation.
- Patients with lumber intervertebral disc, spondylosis, lumbar canal stenosis and spondylolysthesis.
About this study
Official title: Effect of Adding Shock Wave Therapy to Core Stability Exercises in Treatment of Postpartum Sacroiliac Joint Pain: A Single-blinded, Randomized Controlled Trial.
Despite the high popularity and novelty of shock wave therapy (SWT), it is surprising that just one study has examined the effect of SWT on patients with SIJD and their functional ability following treatment by using subjective assessment tools like numeric rating scale (NRS) and limited by its small sample size and lack of long-term follow-up. Therefore, the present study is expected to contribute to the body of knowledge by exploring the effect of adding SWT to core stability exercises in the management of postpartum sacroiliac joint pain.
- Conditions
- Postpartum Sacroiliac Joint Pain
- Being tested
- Shock wave therapy and core stability exercises, core stability exercises only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave therapy and core stability exercisesOther
20 post-partum women with SIJP will be treated by ESWT once weekly combined with core stability exercises 3 times per week for 6 weeks.
core stability exercises onlyOther
20 post-partum women with SIJP will be treated by core stability exercises 3 times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: Shock wave therapy and core stability exercises |
| Control group | Active comparator | Not described Receives: Other: core stability exercises only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacroiliac joint pain intensity
Sacroiliac joint pain intensity will be measured by visual analogue scale
Measured: change from base line at 6 weeks.
pain pressure threshold
pain pressure threshold will be measured by pressure algometer
Measured: change from base line at 6 weeks.
functional disability
functional disability will be measured by Oswestry disability index
Measured: change from base line at 6 weeks
Secondary outcomes (1)
quality of life
quality of life will be measured by the standard quality of life assessment tool which is known as the short-form SF 36 tool
Measured: change from base line at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Nov 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Sacroiliac Joint 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124365
- Sponsor's protocol ID
- Postpartum sacroiliac pain
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Shock Wave Therapy to Core Stability Exercises in Treatment of Postpartum Sacroiliac Joint Pain: A Single-blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06124365
- Acronym / sponsor ID
- Postpartum sacroiliac pain
- Conditions
- Postpartum Sacroiliac Joint Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 9 Nov 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.
Despite the high popularity and novelty of shock wave therapy (SWT), it is surprising that just one study has examined the effect of SWT on patients with SIJD and their functional ability following treatment by using subjective assessment tools like numeric rating scale (NRS) and limited by its small sample size and lack of long-term follow-up. Therefore, the present study is expected to contribute to the body of knowledge by exploring the effect of adding SWT to core stability exercises in the management of postpartum sacroiliac joint pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Shock wave therapy and core stability exercises |
| Control group | Active comparator | Other: core stability exercises only |
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 women diagnosed with SIJP with limitation of its movement referred from the orthopedist.
- Age is between 25-35 years old.
- Their body mass index will be ranged from 25-35 kg/m2.
Key exclusion criteria (9 listed)
- Previous spinal surgery.
- Medical diagnosis other than SIJ dysfunction.
- Patients who had any other spine disorders.
- Patients who had leg length discrepancies.
- Patients with congenital postural deformities.
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 |
|---|---|---|
| Shock wave therapy and core stability exercises20 post-partum women with SIJP will be treated by ESWT once weekly combined with core stability exercises 3 times per week for 6 weeks. | Other | study group |
| core stability exercises only20 post-partum women with SIJP will be treated by core stability exercises 3 times per week for 6 weeks. | Other | Control group |
Primary outcome
Sacroiliac joint pain intensity
Time frame: change from base line at 6 weeks.
Sacroiliac joint pain intensity will be measured by visual analogue scale
pain pressure threshold
Time frame: change from base line at 6 weeks.
pain pressure threshold will be measured by pressure algometer
functional disability
Time frame: change from base line at 6 weeks
functional disability will be measured by Oswestry disability index
1 secondary outcome
quality of life
Time frame: change from base line at 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave therapy and core stability exercises and core stability exercises only in people with Postpartum Sacroiliac Joint Pain, 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 3 inclusion and 9 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 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sacroiliac joint pain intensity (time frame: change from base line at 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?
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 Nov 2023.