Shock Wave and Core Exercises for Postpartum Sacroiliac Pain

November 4, 2023 updated by: Marwa Shafiek Mustafa Saleh, Cairo University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: core stability exercises only
20 post-partum women with SIJP will be treated by core stability exercises 3 times per week for 6 weeks.
Experimental: study group
Other: Shock wave therapy and core stability exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sacroiliac joint pain intensity
Time Frame: change from base line at 6 weeks.
Sacroiliac joint pain intensity will be measured by visual analogue scale
change from base line at 6 weeks.
pain pressure threshold
Time Frame: change from base line at 6 weeks.
pain pressure threshold will be measured by pressure algometer
change from base line at 6 weeks.
functional disability
Time Frame: change from base line at 6 weeks
functional disability will be measured by Oswestry disability index
change from base line at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: change from base line at 6 weeks.
quality of life will be measured by the standard quality of life assessment tool which is known as the short-form SF 36 tool
change from base line at 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

January 25, 2024

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 4, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Postpartum sacroiliac pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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