Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women

November 20, 2021 updated by: Samar Mimi Mohamed Okby

Effect of Shockwave Versus Low Level Laser Therapy on Sacroiliac Joint Pain in Postnatal Women

Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks

Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

25 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postnatal women suffering from sacroiliac joint pain for at least 3 months.
  • They should have moderate to severe pain .
  • They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests

Exclusion Criteria:

  • lumber or hip joint pathology
  • Acute pelvic bacterial or viral infection .
  • Receiving corticosteroid injections within the previous 6 weeks

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: shock wave group
Group A will receive shockwave therapy 2 session per week for 6 weeks
Device: Shockwave
Shock wave master 500 Germany
EXPERIMENTAL: low level laser group
Group B will receive low level laser therapy 2 session per week for 6 weeks
Device: Shockwave
Shock wave master 500 Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sacroiliac joint pain
Time Frame: About two months
•Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score .
About two months
Functional disability
Time Frame: About 2 month
•Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome.
About 2 month
Pain pressure threshold
Time Frame: About 2 month
•Pain pressure threshold : it will be measure by a device Called pressure algometry
About 2 month

Collaborators and Investigators

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

Sponsor

Samar Mimi Mohamed Okby

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 (ANTICIPATED)

November 25, 2021

Primary Completion (ANTICIPATED)

December 3, 2021

Study Completion (ANTICIPATED)

December 29, 2021

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (ACTUAL)

August 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 20, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/003237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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