Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain

This study will be conducted to investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Other: Myofascial release; Device: High-power pain threshold ultrasound

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohamed, Master; Phone Number: +201128588083; Email: ahmedsaifpt226@gmail.com
• Study Contact Backup: Name: Mohamed fawzy, Professor; Phone Number: +201001414404; Email: drmohamedfawzy61@icloud.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Ahmed Mohamed Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myofascial release group; The participants will receive myofascial release three times/week for eight weeks.	Other: Myofascial release; 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.
Experimental: Myofascial release and high-power pain threshold ultrasound group; 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.	Other: Myofascial release; 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.; Device: High-power pain threshold ultrasound; The participants will receive high-power pain threshold ultrasound on sacroiliac joint, 20 minutes, three times/week for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Doaa Osman, Professor, Cairo university; Study Director: Mai Ali, PHD, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2025
• Primary Completion (Estimated): June 12, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia
• Other Study ID Numbers: P.T.REC/012/005376

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No