NCT05779878

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 10, 2023

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain in Shoulder Joint

    Pain will be measured by using Numeric pain rating scale

    4 weeks

  • Range of motion in all planes

    Range of motions in all planes will be measured by using goniometer

    4 weeks

  • Functional disability

    Functional disability will be measured by using Shoulder Pain and Disability Index

    4 weeks

Study Arms (2)

Interventional Group A

EXPERIMENTAL

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

Interventional Group B

EXPERIMENTAL

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

Interventions

Post-isometric relaxation (PIR) is a soft tissue stretching technique used by many health care professionals to lengthen both acute and chronic short muscles.

Interventional Group A

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

Interventional Group B

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allied Hospital

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Sahreen Anwar, Ph.D

CONTACT

Muhammad Talha Hassan Javed, Masters

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

March 9, 2023

Primary Completion

June 9, 2023

Study Completion

June 30, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations