NCT06757933

Brief Summary

This study examines the efficacy of two forms of therapy for Adhesive Capsulitis, a condition characterized by stiffness, pain, and limited mobility in the shoulder joint. It is also commonly known as "Frozen Shoulder".

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 26, 2024

Last Update Submit

January 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Numeric Pain Rating Scale

    (NPRS) was used to measure the subjects' level of pain. This scale helps measure the amount of pain alleviation attained with each intervention by allowing participants to rank their discomfort from 0 (no pain) to 10 (worst possible pain).

    12 Months

  • goniometer

    A goniometer, which measures the angle of joint movement, was used to measure the shoulder's range of motion (ROM). Improvements in shoulder mobility, which is frequently limited in adhesive capsulitis, were assessed with the aid of this assessment.

    12 Months

Study Arms (2)

Interventional group I

EXPERIMENTAL
Combination Product: The Spencer technique

Interventional group II

EXPERIMENTAL
Combination Product: isotonic workouts

Interventions

The Spencer techniqueCOMBINATION_PRODUCT

The Spencer technique, which consists of seven different manual movements intended to increase shoulder mobility and lessen pain, was used to treat the participants in this group. The method seeks to improve blood flow, loosen up the shoulder joint and soft tissues, and reduce any tightness or impingement that is causing pain in the sub-acromial area. By re-establishing appropriate shoulder function and movement patterns, the Spencer approach is commonly used to treat disorders including adhesive capsulitis.

Interventional group I
isotonic workoutsCOMBINATION_PRODUCT

This group's members engaged in isotonic workouts that emphasized forward flexion and extension motions. Both concentric (shortening the muscle) and eccentric (lengthening the muscle) motions were used in these exercises. These exercises were designed to increase shoulder range of motion and strengthen the rotator cuff muscles. People with Adhesive Capsulitis may have less pain and have better shoulder function if they perform isotonic workouts, which increase muscular strength and stability.

Interventional group II

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders aged 30-55 years
  • Unilateral Adhesive Capsulitis
  • Pain lasting for more than one month
  • Capsular pattern of motion restriction
  • Diabetic patients were included.

You may not qualify if:

  • Participants with rotator cuff tear
  • Rheumatoid and gouty arthritis
  • Tumors of the shoulder region
  • Peripheral nerve injuries
  • Shoulder girdle fracture and dislocation
  • History of shoulder surgery were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Saleem Memorial Free Hospital Address: College road, Depalpur Rd, adjacent baldia hall, Okara

Okāra, 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

December 26, 2024

First Posted

January 3, 2025

Study Start

February 15, 2024

Primary Completion

May 25, 2024

Study Completion

March 2, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations