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

NCT06820827 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005376
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sacroiliac Joint Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Function disability

  8 weeks

Study Arms (2)

Myofascial release group

ACTIVE COMPARATOR

The participants will receive myofascial release three times/week for eight weeks.

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.

Other: Myofascial release; Device: High-power pain threshold ultrasound

Interventions

Myofascial release OTHER

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.

Myofascial release and high-power pain threshold ultrasound group; Myofascial release group

High-power pain threshold ultrasound DEVICE

The participants will receive high-power pain threshold ultrasound on sacroiliac joint, 20 minutes, three times/week for eight weeks.

Myofascial release and high-power pain threshold ultrasound group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Mohamed Mohamed

Cairo, Egypt

Location

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mai Ali, PHD

  Cairo University

  STUDY DIRECTOR

• Doaa Osman, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ahmed Mohamed, Master

CONTACT

+201128588083; ahmedsaifpt226@gmail.com

Mohamed fawzy, Professor

CONTACT

+201001414404; drmohamedfawzy61@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 12, 2025
• Primary Completion: June 12, 2025
• Study Completion: June 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

EG (1)