Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy

November 19, 2024 updated by: Riphah International University

Effects of Active Tissue Release Techniques on Groin Pain, Hip Range of Motion, and Functional Disability in 2nd Trimester of Pregnancy

The study will focus on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. This will be a randomized controlled trial conducted on 30 participants from Prime Care Hospital. Pregnant women in the second trimester aged between 25 to 35 years, who have groin or round ligament pain will be included in this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises. Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through Quebec scale and Force Disability Scale Questionnaire in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Groin pain mostly occurs in the first and second trimesters of pregnancy due to round ligament pain because the womb expands and causes stretching of ligaments making it more likely to become strained. The study will be focused on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. A baseline treatment of ice therapy will be given for 10 minutes to all participants of this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises.

Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through the Quebec scale and Force Disability Scale Questionnaire in both groups. Recorded values will be analyzed for any change using SPSS

Study Type

Interventional

Enrollment (Actual)

30

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

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Prime Care Hospital

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

Yes

Description

Inclusion Criteria:

  • Pain in the groin area/ Round Ligament pain
  • NPRS scores between 4 to 10
  • Functional activities scoring between 50 to 90 at Quebec score

Exclusion Criteria:

  • Any diagnosed pathology like infection , malignancy ,inflammation
  • Any structural deformity of lumbar and pelvic girdle,
  • Any inguinal or lumbar surgery
  • High risk pregnancy

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
Experimental: active tissue release technique group
The group will be treated by active release techniques for 4 weeks, 3 sessions per week. One session will be for 10 minutes. Before each session, an ice pack is applied to the groin area for inflammation if present.
Other: Active release techniques
Active release techniques are soft tissue systems or movement-based techniques. It is used to treat muscles, nerves, fascia, ligaments, and tendons.
Active Comparator: Relaxation exercises Group
Group B will be treated by relaxation exercises only. Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises.
Other: Relaxation exercises
Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises. Exercises will be done in a sitting position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: up to 4 weeks
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes. Changes from Baseline to 4 week.
up to 4 weeks
The Quebec questionnaire:
Time Frame: up to 4 weeks
The Quebec questionnaire is a condition-specific questionnaire developed to measure the level of functional disability for patients with groin pain. The original purpose of the questionnaire is to take into account the functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of groin pain subjects incorporated in rehabilitation programs
up to 4 weeks
Goniometer: To measure range of motion:
Time Frame: up to 4 weeks
A goniometer is a device that measures an angle or permits the rotation of an object to a definite position the range of motion is the measurement of movement around a specific joint or body part.
up to 4 weeks

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Khadija shamas, MS*, Riphah International University, Lahore, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

October 5, 2024

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC/RCR & AHS/23/0567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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