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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings