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

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Post Isometric Relaxation
Myofascial arm pull technique
Sponsored by
Sahreen Anwar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Allied HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Interventional Group A

Interventional Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain in Shoulder Joint
Pain will be measured by using Numeric pain rating scale
Range of motion in all planes
Range of motions in all planes will be measured by using goniometer
Functional disability
Functional disability will be measured by using Shoulder Pain and Disability Index

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
March 10, 2023
Sponsor
Sahreen Anwar
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1. Study Identification

Unique Protocol Identification Number
NCT05779878
Brief Title
Comparative Effects of Myofascial Arm Pull Technique and Post Isometric Relaxation on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis After Mastectomy
Official Title
Comparative Effects of Myofascial Arm Pull Technique and Post Isometric Relaxation on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis After Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
June 9, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sahreen Anwar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Interventional Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Post Isometric Relaxation
Intervention Description
Post-isometric relaxation (PIR) is a soft tissue stretching technique used by many health care professionals to lengthen both acute and chronic short muscles.
Intervention Type
Other
Intervention Name(s)
Myofascial arm pull technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain in Shoulder Joint
Description
Pain will be measured by using Numeric pain rating scale
Time Frame
4 weeks
Title
Range of motion in all planes
Description
Range of motions in all planes will be measured by using goniometer
Time Frame
4 weeks
Title
Functional disability
Description
Functional disability will be measured by using Shoulder Pain and Disability Index
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahreen Anwar, Ph.D
Phone
00923346591705
Email
sahreenanwar@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Talha Hassan Javed, Masters
Phone
03348196967
Email
drtalhahassan97@gmail.com
Facility Information:
Facility Name
Allied Hospital
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sobia Nawaz
Ext
Javed
Email
drtalhahassan97@gmail.com
First Name & Middle Initial & Last Name & Degree
Muhammad Talha Hassan Javed, Masters
First Name & Middle Initial & Last Name & Degree
Amna Aslam, DPT
First Name & Middle Initial & Last Name & Degree
Rimsha Zafar, DPT
First Name & Middle Initial & Last Name & Degree
Sanam Hassan, DPT

12. IPD Sharing Statement

Learn more about this trial

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

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