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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05338853
Other study ID # REC/RCR&AHS/22/0103
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2022
Est. completion date December 15, 2022

Study information

Verified date July 2022
Source Riphah International University
Contact Dr. Rabiya Noor, PhD
Phone 00923344355660
Email rabiya.noor@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adhesive Capsulitis also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. I Different physical therapy techniques and modalities have been used in reducing pain and increasing ROM in frozen shoulder. It is a randomized clinical trial and random sampling was used with an inclusion criterion of confirmed adhesive capsulitis patients. This study aims to provide a comparative analysis of two mobilizations: Gongs and Scapular mobilization in terms of effects on pain, range of motion and functional status. Patients having acute inflammation, fracture, dislocation or any surgery around the shoulder joint were excluded from the study. Subjects were randomly allocated into two groups with group A receiving Gongs mobilization and group B receiving scapular mobilization in addition to Continuous passive motion which was given as a baseline therapy to both the groups. Total duration of the study was 6 months. Numeric pain rating scale, universal goniometry and Shoulder pain and disability index were used to measure the pain, range of motion and functionality respectively at the start and end of study. After collecting data from defined study setting, data was entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test to be used.


Description:

Adhesive Capsulitis also known as frozen shoulder is a self-limiting disorder of the shoulder joint characterized by pain, loss of joint ROM and functional limitation which usually resolves in 12-15 months. It develops when the glenohumeral capsule undergoes inflammation and is fibrosed as a result. Shoulder of an Adhesive capsulitis patient undergoes three stages; Freezing(0-6 months), Frozen (4 months-6 months) and Thawing(6 months- 2 years). Physical therapy is of considerable importance in management of adhesive capsulitis patients. Different physical therapy techniques and modalities have been used in reducing pain and increasing ROM in frozen shoulder. It is a randomized clinical trial and random sampling was used with an inclusion criterion of confirmed adhesive capsulitis patients. This study aims to provide a comparative analysis of two mobilizations: Gongs and Scapular mobilization in terms of effects on pain, range of motion and functional status. Patients having acute inflammation, fracture, dislocation or any surgery around the shoulder joint were excluded from the study. Subjects were randomly allocated into two groups with group A receiving Gongs mobilization and group B receiving scapular mobilization in addition to Continuous passive motion which was given as a baseline therapy to both the groups. Total duration of the study was 6 months. Numeric pain rating scale, universal goniometry and Shoulder pain and disability index were used to measure the pain, range of motion and functionality respectively at the start and end of study. After collecting data from defined study setting, data was entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test to be used.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: Confirmed Adhesive Capsulitis patients (Stage 2 and 3) - ROM restriction in capsular pattern (External rotation > abduction > internal rotation) - Functional tests positive (Hand to neck, hand to scapula) - Both active and passive movement ranges limited. - Males and Females of age 40-60 years Exclusion Criteria: 1. Stage 1 Adhesive Capsulitis. 2. Acute inflammation 3. Recent fracture in and around the shoulder 4. Recent shoulder dislocation 5. Past surgery around shoulder joint

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gongs mobilization
to deal adhesive capsulitis
scapular mobilization
scapular mobilization

Locations

Country Name City State
Pakistan Railway Hospital Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale The 11-point NPRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The respondent is instructed to identify one number between 0 and 10, which is best representative of their pain intensity. 4months
Primary Degree of Range of motion goniometer will be used to take ranges 4 months
Primary The Shoulder Pain and Disability Index (SPADI) The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. 4 months
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