Sacroiliac Joint DysfunctionNCT06820827
Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain
A study testing Myofascial release and High-power pain threshold ultrasound in people with Sacroiliac Joint Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Myofascial release and High-power pain threshold ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum women diagnosed with sacroiliac joint pain and referred by an orthopedist.
- Their ages will range from 20 to 30 years old.
- Their body mass index (BMI) will range from 25 to 29.9 kg/m2.
- All of them should have symptoms for at least two weeks postnatal
Who cannot join
- Kidney diseases like stones or renal failure
- History of ischemic heart diseases or Myocardial infarction
- Severe vitamin D3 deficiency
- Severe liver diseases or hepatitis
- Psychological distress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain.
Read the detailed description
Sacroiliac joint pain (SIJ) in the pregnant and postpartum females is susceptible to dysfunction due to multiple biomechanical changes that happen over the course of gestation. This includes an increased angle of lordosis, weight gain, and structural trauma due to the physiologic process of childbirth, biomechanical changes, along with hormonal fluctuations through each trimester, particularly with increased levels of estrogen and relaxin, have been found to decrease the stability of the joint leading to sustained postpartum back pain that may necessitate surgical intervention if conservative treatment fails.
PGP can result in significant physical disability and has important psychosocial implications, including extended leave from work during pregnancy and postnatal, poorer quality of life (as a result of being unable to carry out normal roles, affecting their ability to care for their children and the new baby) and predisposition to chronic pain.
There are side effects to using medical treatment for PGP, such as bruising, bleeding, stomach upset (including bleeding in the stomach), peptic (stomach) ulcers, blurred vision, constipation, dry mouth, fatigue, headaches, insomnia, mood changes, nausea, urination problems, and weight gain. So, using other treatment methods, such as ultrasound therapy to treat PGP is beneficial.
Ultrasound therapy is a non-invasive treatment in which sound waves penetrate soft tissues, increasing blood flow; this can help relieve pain, improve circulation, and promote tissue healing. As such, ultrasound therapy is often used to treat injuries, muscle spasms, and chronic issues like neck or back pain.
No previous study has investigated the effect of high-power pain ultrasound on sacroiliac pain in postpartum women. So, this study aims to investigate the effect of high-power ultrasound on postnatal sacroiliac joint pain.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Myofascial release, High-power pain threshold ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseOther
The participants will receive myofascial release (MFR) on erector spinae, quadratus lumborum, piriformis and gluteus medius. The duration of MFR for each muscle will be 90 to 120 seconds, three times/week for eight weeks.
High-power pain threshold ultrasoundDevice
The participants will receive high-power pain threshold ultrasound on sacroiliac joint, 20 minutes, three times/week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release group | Active comparator | The participants will receive myofascial release three times/week for eight weeks. Receives: Other: Myofascial release |
| Myofascial release and high-power pain threshold ultrasound group | Experimental | The participants will receive myofascial release in addition to a high-power pain threshold ultrasound on the sacroiliac joint for 20 minutes three times a week for eight weeks. Receives: Other: Myofascial release; Device: High-power pain threshold ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
A numerical rating scale will be used to evaluate pain intensity for all participants before and after the end of the treatment program. It will be given to each participant to rate her intensity of pain. 0 indicates no Pain, 1-3 indicates mild pain (nagging, annoying, interfering little with activity of daily living (ADLs), 4-6 indicates moderate pain (interferes significantly with ADLs), and 7-10 indicates severe pain (disabling; unable to perform ADLs).
Measured: 8 weeks
Pressure pain threshold (PPT)
A pressure algometry (Force Dial model FDK 20 Push Pull Force Gage, Wagner Instruments, Greenwich CT, USA) will be used to assess pain sensitivity by measuring pressure pain thresholds (PPT) at five selected points in the sacroiliac joint region of the affected side. The first examined point will be 1 cm medial and inferior to the posterior superior iliac spine, while the other four examined points will be 2 cm lateral, medial, superior, and inferior to the first point. Each point was measured three times with a ten-second interval between them; the mean of them will be then calculated for each point to be utilized for statistical analysis.
Measured: 8 weeks
Secondary outcomes (1)
Function disability
Pelvic Pain Impact Questionnaire (PPIQ) will be used to assess function disability. It consists of 8 questions that get scored 0-4, for a total of 32. 0 indicates no at all and 4 indicates great deal.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start12 Feb 2025 (estimated)
- Primary completion12 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Hassan, Cairo University
- Investigators
- Mai Ali, PHD, Study director, Cairo UniversityDoaa Osman, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820827
- Sponsor's protocol ID
- P.T.REC/012/005376
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 17 Feb 2025
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT06820827
- Acronym / sponsor ID
- P.T.REC/012/005376
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2025 (estimated)
- Primary completion
- 12 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Feb 2025 (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 investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain.
Detailed description
Sacroiliac joint pain (SIJ) in the pregnant and postpartum females is susceptible to dysfunction due to multiple biomechanical changes that happen over the course of gestation. This includes an increased angle of lordosis, weight gain, and structural trauma due to the physiologic process of childbirth, biomechanical changes, along with hormonal fluctuations through each trimester, particularly with increased levels of estrogen and relaxin, have been found to decrease the stability of the joint leading to sustained postpartum back pain that may necessitate surgical intervention if conservative treatment fails.
PGP can result in significant physical disability and has important psychosocial implications, including extended leave from work during pregnancy and postnatal, poorer quality of life (as a result of being unable to carry out normal roles, affecting their ability to care for their children and the new baby) and predisposition to chronic pain.
There are side effects to using medical treatment for PGP, such as bruising, bleeding, stomach upset (including bleeding in the stomach), peptic (stomach) ulcers, blurred vision, constipation, dry mouth, fatigue, headaches, insomnia, mood changes, nausea, urination problems, and weight gain. So, using other treatment methods, such as ultrasound therapy to treat PGP is beneficial.
Ultrasound therapy is a non-invasive treatment in which sound waves penetrate soft tissues, increasing blood flow; this can help relieve pain, improve circulation, and promote tissue healing. As such, ultrasound therapy is often used to treat injuries, muscle spasms, and chronic issues like neck or back pain.
No previous study has investigated the effect of high-power pain ultrasound on sacroiliac pain in postpartum women. So, this study aims to investigate the effect of high-power ultrasound on postnatal 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 |
|---|---|---|
| Myofascial release group | Active comparator | Other: Myofascial releaseThe participants will receive myofascial release three times/week for eight weeks. |
| Myofascial release and high-power pain threshold ultrasound group | Experimental | Other: Myofascial release, Device: High-power pain threshold ultrasoundThe participants will receive myofascial release in addition to a high-power pain threshold ultrasound on the sacroiliac joint for 20 minutes three times a week for eight weeks. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Postpartum women diagnosed with sacroiliac joint pain and referred by an orthopedist.
- Their ages will range from 20 to 30 years old.
- Their body mass index (BMI) will range from 25 to 29.9 kg/m2.
- All of them should have symptoms for at least two weeks postnatal
Key exclusion criteria (5 listed)
- Kidney diseases like stones or renal failure
- History of ischemic heart diseases or Myocardial infarction
- Severe vitamin D3 deficiency
- Severe liver diseases or hepatitis
- Psychological distress
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 |
|---|---|---|
| Myofascial releaseThe participants will receive myofascial release (MFR) on erector spinae, quadratus lumborum, piriformis and gluteus medius. The duration of MFR for each muscle will be 90 to 120 seconds, three times/week for eight weeks. | Other | Myofascial release and high-power pain threshold ultrasound group, Myofascial release group |
| High-power pain threshold ultrasoundThe participants will receive high-power pain threshold ultrasound on sacroiliac joint, 20 minutes, three times/week for eight weeks. | Device | Myofascial release and high-power pain threshold ultrasound group |
Primary outcome
Pain intensity
Time frame: 8 weeks
A numerical rating scale will be used to evaluate pain intensity for all participants before and after the end of the treatment program. It will be given to each participant to rate her intensity of pain. 0 indicates no Pain, 1-3 indicates mild pain (nagging, annoying, interfering little with activity of daily living (ADLs), 4-6 indicates moderate pain (interferes significantly with ADLs), and 7-10 indicates severe pain (disabling; unable to perform ADLs).
Pressure pain threshold (PPT)
Time frame: 8 weeks
A pressure algometry (Force Dial model FDK 20 Push Pull Force Gage, Wagner Instruments, Greenwich CT, USA) will be used to assess pain sensitivity by measuring pressure pain thresholds (PPT) at five selected points in the sacroiliac joint region of the affected side. The first examined point will be 1 cm medial and inferior to the posterior superior iliac spine, while the other four examined points will be 2 cm lateral, medial, superior, and inferior to the first point. Each point was measured three times with a ten-second interval between them; the mean of them will be then calculated for each point to be utilized for statistical analysis.
1 secondary outcome
Function disability
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Related trials for Sacroiliac Joint Dysfunction
Not yet recruiting
Effect of Retro Walking in Patients With Sacroiliac Joint Dysfunction
Sacroiliac Joint Dysfunction
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruitingObservational study
Correlation Between Trunk Muscles Endurance and Dynamic Balance in Sacroiliac Joint Dysfunction
Trunk Extensor Muscle Endurance
Active, not recruitingObservational study
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sacroiliitis, Sacroiliac Joint Dysfunction
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.
Mai Ali, PHD study director
Cairo University
Doaa Osman, Professor study chair
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 Myofascial release and High-power pain threshold ultrasound 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 4 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: opening soon, as of the sponsor's last update on 17 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed, Master (+201128588083, ahmedsaifpt226@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 8 weeks). 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 17 Feb 2025.