NCT05338853

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.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

April 15, 2022

Last Update Submit

July 14, 2022

Conditions

Keywords

Adhesive capsulitis, Gong's mobilization,

Outcome Measures

Primary Outcomes (3)

  • 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

  • Degree of Range of motion

    goniometer will be used to take ranges

    4 months

  • 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

Study Arms (2)

Gongs Mmobilization

EXPERIMENTAL

to deal adhesive capsulitis

Other: Gongs mobilization

scapular mobilization

EXPERIMENTAL

to deal adhesive capsulitis

Other: scapular mobilization

Interventions

to deal adhesive capsulitis

Gongs Mmobilization

scapular mobilization

scapular mobilization

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Stage 1 Adhesive Capsulitis.
  • Acute inflammation
  • Recent fracture in and around the shoulder
  • Recent shoulder dislocation
  • Past surgery around shoulder joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway Hospital

Islamabad, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Dr. Rabiya Noor, PhD

    Riphah International University

    STUDY CHAIR

Central Study Contacts

Dr. Rabiya Noor, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 21, 2022

Study Start

June 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations