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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05779878
Other study ID # REC_FSD_00319
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 9, 2023
Est. completion date June 30, 2023

Study information

Verified date March 2023
Source Riphah International University
Contact Sahreen Anwar, Ph.D
Phone 00923346591705
Email sahreenanwar@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2023
Est. primary completion date June 9, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Pakistan Allied Hospital Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Sahreen Anwar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain in Shoulder Joint Pain will be measured by using Numeric pain rating scale 4 weeks
Primary Range of motion in all planes Range of motions in all planes will be measured by using goniometer 4 weeks
Primary Functional disability Functional disability will be measured by using Shoulder Pain and Disability Index 4 weeks
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