Manual Therapy for Pregnancy Related Back Pain

January 8, 2024 updated by: Aliaa Mohamed Elabd, Benha University

Effect of Tui-Na Versus Positional Release Techniques on Pregnancy Related Low Back Pain in the Third Trimester. A Randomized Trial

More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Manual therapy techniques can minimize loading of the spine while improving muscular endurance and preventing fatigue. Moreover, inhibition of the trigger points of the spinal musculature is an important factor to consider.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Tui-Na massage and positional release therapy are both of the common manual therapies used recently for low back pain. However, no studies have compared their effects on pregnancy related low back pain in third trimester.

Study Type

Interventional

Enrollment (Estimated)

40

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 Locations

  • Egypt
    • Benah
      • Cairo, Benah, Egypt, 13518
        • Benha University

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:

  • low back pain
  • mild to moderate disability concurring to the Oswestry Disability Index (up to 40%),
  • age ranged from 20 - 40 years

Exclusion Criteria:

  • Current physical therapy or medical treatment for low back pain,
  • contracture or surgery affecting the lumbar spine,
  • scoliosis,
  • pathologies such as inflammatory diseases,
  • skin diseases,
  • congenital diseases,
  • neurological diseases,
  • dislocations, neoplasms,
  • disc prolapse,
  • visual or auditory problems

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tui-na
Application of tui-na techniques for the women while being in prone lying position.
Procedure: Tui-na massage
Using Tui-na massage for the back muscles
Active Comparator: positional release techniques
Application of positional release techniques for the women while being in prone lying position.
Procedure: positional release technique
using positional release manual technique to relax the back muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
back pain intensity
Time Frame: through study completion, an average of 2 months
will be measure by the visual analogue scale that range from 0 to 10 with higher scores indicating greater pain intensity.
through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pressure pain threshold (kg/cm2)
Time Frame: through study completion, an average of 2 months
will be measured using a pressure algometer that will be placed vertically on the most tender point at the low back para spinal muscles.
through study completion, an average of 2 months

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Aliaa M Elabd, Benha 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)

January 15, 2024

Primary Completion (Estimated)

February 27, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT.BU.EC.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

will be available upon reasonable request

IPD Sharing Time Frame

upon completion

IPD Sharing Access Criteria

URL will be created after the ending of data acquisition.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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