- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913361
Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis
March 29, 2025 updated by: Muhammad Naveed Babur, Superior University
Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS).
Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%.
This study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis.
This study will be a randomized control trial and data will be collected from Haq Orthopedic Hospital.
Sample size is 20 calculated by using G power and adding 20 % attrition.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Non-Probability convenient sampling will be used.
Participants meeting the inclusion and exclusion criteria will be divided into two groups.10
subjects in group A will be treated Gongs mobilization and group B will be treated with Reverse distraction technique.
Conventional therapy will be given to both groups as base line treatment.
Both groups have 4 sessions per week for 4 weeks.
All participants will be evaluated before and after the treatment using Numeric Pain Rating scale (NPRS), Shoulder pain and Disability Index (SPADI) and goniometer.
Study Type
Interventional
Enrollment (Actual)
20
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 Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Haq Orthopaedic hospital, Sanda road
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both males and females.
- Diagnosed case of Unilateral Adhesive Capsulitis.
- Age group of 40-60 years.
- Stage 2 and 3 of Adhesive Capsulitis.
- Diabetes Mellitus Type II.
- Patients with decreased ROM (less than or equal to 120 degrees), pain, and mild to moderate levels of type II diabetics (below or equal to 200 mg/dL).
- No history of shoulder surgeries to the affected shoulder.
Exclusion Criteria:
- Systemic arthritic conditions of the shoulder (Rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) .
- Disorders of the Cervical spine .
- Corticosteroids injections in the affected Shoulder in preceding 6 weeks.
- Skin lesions or bruises around the Shoulder.
- Shoulder injuries such as Rotator cuff tear.
- Fracture in and around the shoulder joint.
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gongs Mobilization
|
The treatment begins with moist heat for 10 minutes, Gong's mobilization with conventional therapy for 8 minutes.
The total treatment time was 45 minutes once a day for four days per week for four weeks.
|
|
Experimental: Reverse Distraction Technique
|
The treatment begins with moist heat for 10 minutes, Reverse Distraction technique with conventional therapy for 8 minutes.
The total treatment time was 45 minutes once a day for four days per week for four weeks.
Position of the patient: side-lying.
The patient is lying at the plinth's edge on the unaffected side.
In front of the patient is the therapist's position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NUMERIC PAIN RATING SCALE (NPRS)
Time Frame: 12 Months
|
Value of sensitivity/specificity/ validity/reliability: intra-class correlation coefficient 0.58 to 0.93.
Measurement: Numerical Interpretation: The Numeric Pain Rating Scale (NPRS) is a simple and widely used tool for assessing pain intensity.
Patients rate their pain on a scale from 0 to 10, where 0 indicates ""no pain"" and 10 indicates ""worst pain imaginable.""
The interpretation of NPRS scores helps classify pain severity and monitor changes over time.
|
12 Months
|
|
SHOULDER PAIN AND DISABILITY INDEX
Time Frame: 12 Months
|
The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability.
The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 20, 2025
Primary Completion (Estimated)
June 20, 2025
Study Completion (Estimated)
February 10, 2026
Study Registration Dates
First Submitted
March 29, 2025
First Submitted That Met QC Criteria
March 29, 2025
First Posted (Actual)
April 6, 2025
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
March 29, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall23/791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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