Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization in Adhesive Capsulitis

February 15, 2023 updated by: Umama Abbasi, Dow University of Health Sciences

Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization Versus Shoulder Mobilization Alone in Adhesive Capsulitis

This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. The study will be conducted at physiotherapy outpatient department (OPD) of Sindh Institute of physical medicine and rehabilitation, and Dow University Ojha Campus, Karachi. According to study criteria, 70 patients with sub-acute adhesive capsulitis will be selected through a non-randomized purposive sampling technique by a consultant physician. After taking informed consent, participants will be randomly divided into 2 groups through the sealed envelope method. Both the groups will receive conventional treatment while Group 1 will be given an additional treatment of myofascial release of subscapularis through ischemic compression technique. Total 6 treatment sessions will be provided and assessment will be done at baseline and end of the 6th session.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The sample size of 31 per group was determined using planning and specification software (PASS) version 15 software based on two independent sample t-test using 95%confidence interval and 80% power of the test. This sample was raised to 35 per group with 4 patients as drop out per group. Mean and standard deviation will be calculated for the quantitative variables while frequency and percentages will be calculated for qualitative variables. Inter-group comparison at baseline will be calculated using an independent sample t-test. The mean difference between both the techniques in terms of numeric pain rating scale (NPRS), range of motion (ROM), shoulder pain and disability index (SPADI), and pain pressure threshold(PPT) will be determined using Repeated measure 2-way ANOVA.

Study Type

Interventional

Enrollment (Anticipated)

70

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

  • Name: Aftab Ahmed Mirza Baig, MSAPT
  • Phone Number: +923002739920
  • Email: ab.dptrm@gmail.com

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Recruiting
        • Sindh Institute Physical Medicine and Rehabilitation
        • Contact:
        • Principal Investigator:
          • Umama Abbasi, DPT
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Dow University Hospital Ojha Campus
        • Principal Investigator:
          • Umama Abbasi, DPT
        • Contact:

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 40-65 years
  • Diagnosed with sub-acute adhesive capsulitis
  • Pain range of 3 to 8 on NPRS
  • SPADI score of >40
  • Presence of myofascial trigger point in subscapularis muscle

Exclusion Criteria:

  • History of fracture
  • Rheumatoid arthritis
  • Shoulder osteoarthritis
  • Any malignancy
  • Shoulder dislocation
  • Subacute adhesive capsulitis with impingement syndrome

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: Maitland mobilization with myofascial trigger point release group

Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets.

Ischemic Compression technique: on subscapularis trigger points for 90 secs thrice a week for 2 weeks.

Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins
Other: Myofascial release of subscapularis
It is the application of manual pressure over myofascial trigger point that induces ischemia and causes release of trigger points
Other: Maitland mobilization
It is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion
Other: Stretching exercises
It is the technique use to increase flexibility and range of motion of short and hypomobile structures
Other: Cold pack
It is the application of cold to provide analgesic effects
Active Comparator: Maitland mobilization alone group

Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets.

Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins
Other: Maitland mobilization
It is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion
Other: Stretching exercises
It is the technique use to increase flexibility and range of motion of short and hypomobile structures
Other: Cold pack
It is the application of cold to provide analgesic effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)
Time Frame: At baseline and after 6 sessions (10 days)
It will be use to assess pain intensity. It will be administered by simply asking the intensity of pain experienced in last 24 hours. The response of 0 represent no pain rather the responses between 1-3, 4-6, and 7-9 represents mild, moderate, and severe pain respectively. While 10 is the worst possible pain ever experienced by the person
At baseline and after 6 sessions (10 days)
Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)
Time Frame: At baseline and after 6 sessions (10 days)
It will be assessed by using standard universal goniometer and measured in degrees
At baseline and after 6 sessions (10 days)
change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)
Time Frame: At baseline and after 6 sessions (10 days)
Shoulder pain and disability index is used to assess shoulder disability. It consist of 13 questions i .e. 5 to assess pain and 8 to assess disability. Results will be calculated in percentage and higher results indicate increased disability. lower the percentage better will be the outcome.
At baseline and after 6 sessions (10 days)
Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)
Time Frame: At baseline and after 6 sessions (10 days)
assessed through algometer which provide sustained pressure from 0.05Newton/second to 20 Newton/second. Results will be recorded in kilogram/centimeter2 and higher values indicate decrease sensitivity of myofascial trigger points
At baseline and after 6 sessions (10 days)

Collaborators and Investigators

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

Sponsor

Dow University of Health Sciences

Investigators

  • Study Director: Aftab Ahmed Mirza Baig, MSAPT, Sindh Institute of Physical Medicine and Rehabilitation
  • Principal Investigator: Umama Abbasi, DPT, Dow University of Health Sciences
  • Study Director: Rabail R Soomro, PhD Scholar, Sindh Institute of Physical Medicine and Rehabilitation

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)

April 26, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAbbasi

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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