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Comparative Effects of Gongs Mobilization and Scapular Mobilization on Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gongs mobilization
scapular mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive capsulitis, Gong's mobilization,

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Railway HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gongs Mmobilization

scapular mobilization

Arm Description

to deal adhesive capsulitis

to deal adhesive capsulitis

Outcomes

Primary Outcome Measures

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.
Degree of Range of motion
goniometer will be used to take ranges
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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2022
Last Updated
July 14, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05338853
Brief Title
Comparative Effects of Gongs Mobilization and Scapular Mobilization on Adhesive Capsulitis
Official Title
Comparative Effects of Gongs Mobilization and Scapular Mobilization on Pain, Range of Motion and Disability in Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive capsulitis, Gong's mobilization,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gongs Mmobilization
Arm Type
Experimental
Arm Description
to deal adhesive capsulitis
Arm Title
scapular mobilization
Arm Type
Experimental
Arm Description
to deal adhesive capsulitis
Intervention Type
Other
Intervention Name(s)
Gongs mobilization
Intervention Description
to deal adhesive capsulitis
Intervention Type
Other
Intervention Name(s)
scapular mobilization
Intervention Description
scapular mobilization
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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.
Time Frame
4months
Title
Degree of Range of motion
Description
goniometer will be used to take ranges
Time Frame
4 months
Title
The Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Stage 1 Adhesive Capsulitis. Acute inflammation Recent fracture in and around the shoulder Recent shoulder dislocation Past surgery around shoulder joint
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Rabiya Noor, PhD
Phone
00923344355660
Email
rabiya.noor@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Railway Hospital
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
myera mudassir, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparative Effects of Gongs Mobilization and Scapular Mobilization on Adhesive Capsulitis

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