NCT06913361

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • NUMERIC PAIN RATING SCALE (NPRS)

    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

    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

Study Arms (2)

Gongs Mobilization

EXPERIMENTAL
Diagnostic Test: Gongs Mobilization

Reverse Distraction Technique

EXPERIMENTAL
Combination Product: Reverse Distraction Technique

Interventions

Gongs MobilizationDIAGNOSTIC_TEST

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.

Gongs Mobilization

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.

Reverse Distraction Technique

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haq Orthopaedic hospital, Sanda road

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 10, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations