Comparative Effects of Myofascial Arm Pull Technique and Post Isometric Relaxation on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis After Mastectomy

March 10, 2023 updated by: Sahreen Anwar
Adhesive capsulitis (AC) also known as frozen shoulder typically manifests to decrease range of motion (ROM) and function and increase pain in shoulder .Objective of the study is To compare the effects of Myofascial Arm Pull Technique and Post-isometric Relaxation on Pain, Range of Motion and functional disability in adhesive capsulitis after mastectomy. The study design will be a Randomized Clinical Trial that will be used to compare the effects of Myofascial arm pull technique with post isometric relaxation. Subject with adhesive capsulitis meeting the predetermined inclusion & exclusion criteria will be divided into two groups. Pre assessment will be done using numeric pain rating scale NPRS for pain , shoulder pain and disability index (SPADI) tool for disability and Goniometer for Range of motion. Consent will be taken from patients by consent form the patients. They will be divided into two groups randomly by Random Number Generator table: Group A and Group B. For common treatment, both the groups will receive Ultrasound with a dosage of 1 MHz in frequency, continuous mode and 1.5 W/ cm2 of intensity for 10 minutes of treatment duration and Movement with mobilization will be applied for 15 times in 3 sets, and a 1- minute rest period was provided between each set. Group A will be given Post isometric relaxation technique with ultrasonic therapy. Group B will be given myofascial arm pull technique with ultrasonic. Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions. In Post isometric relaxation technique the therapist will slowly provide resistance in the direction of flexion, abduction, or external rotation, and without the subject intending to move for 15 minutes/ day, 3 times/week for 12 weeks. Similarly, myofascial arm pull technique the therapist will hold arm of the subject firmly and initial stretch will be applied in abduction and external rotation for 8-10 times in each session per day for 3 days/week for 4 weeks. Outcome measures will be measured at baseline, after 2 weeks and after 4 weeks. Data analysis will be done by SPSS version 25.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Recruiting
        • Allied Hospital
        • Contact:
          • Sobia Nawaz
        • Contact:
        • Principal Investigator:
          • Muhammad Talha Hassan Javed, Masters
        • Sub-Investigator:
          • Amna Aslam, DPT
        • Sub-Investigator:
          • Rimsha Zafar, DPT
        • Sub-Investigator:
          • Sanam Hassan, DPT

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Only Female gender
  • Age between 25 to 50 years with post mastectomy.
  • Diagnosis of breast cancer (grade 1to3 b).
  • Post mastectomy state at least 6 months.
  • Shoulder pain that began after the breast cancer surgery

Exclusion Criteria:

  • Bilateral breast cancer.
  • History of neurologic deficits affecting shoulder functioning during daily activites.
  • On numeric pain rating scale pain will be less than 5.

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: Interventional Group A
This group will be given Post isometric relaxation technique. Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions.
Other: Post Isometric Relaxation
Post-isometric relaxation (PIR) is a soft tissue stretching technique used by many health care professionals to lengthen both acute and chronic short muscles.
Experimental: Interventional Group B
This Group will be given myofascial arm pull technique . Total intervention protocol will be given for four weeks of duration 3 sessions per week with total 12 sessions.
Other: Myofascial arm pull technique
Myofascial therapy is described as the promotion of psychophysiological, neurological and structural adaptive capability as multiplexed via the myofascial system. Fascia covers all body structures, particularly muscles and their constituent myofibrils

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in Shoulder Joint
Time Frame: 4 weeks
Pain will be measured by using Numeric pain rating scale
4 weeks
Range of motion in all planes
Time Frame: 4 weeks
Range of motions in all planes will be measured by using goniometer
4 weeks
Functional disability
Time Frame: 4 weeks
Functional disability will be measured by using Shoulder Pain and Disability Index
4 weeks

Collaborators and Investigators

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

Sponsor

Sahreen Anwar

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)

March 9, 2023

Primary Completion (Anticipated)

June 9, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC_FSD_00319

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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