NCT07520604

Brief Summary

Adhesive capsulitis (AC) is a common painful disorder associated with diminishing glenohumeral movement. This has led to the need for an evidence-based approach to assess the isokinetic strength and endurance of shoulder muscles in such disease conditions.The main aim of the current study was to determine whether isokinetic dynamometric values of peak torque (PT) and fatigue index of shoulder muscles are different between patients with AC in the recovery phase and the healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2016

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

March 27, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

Adhesive Capsulitisfrozen shoulderfatigue indexisokinetic dynamometrypeak torque

Outcome Measures

Primary Outcomes (6)

  • shoulder abductor peak torque

    shoulder abductor isokinetic peak torque

    one year

  • shoulder internal rotator peak torque

    shoulder internal rotator isokinetic peak torque

    one year

  • shoulder external rotator peak torque

    shoulder external rotator isokinetic peak torque

    one year

  • shoulder abductor fatigue index

    shoulder abductor isokinetic fatigue index

    one year

  • shoulder internal rotator fatigue index

    shoulder internal rotator isokinetic fatigue index

    one year

  • shoulder external rotator fatigue index

    shoulder external rotator isokinetic fatigue index

    one year

Study Arms (2)

healthy control group

30 healthy controls participated in the study

Diagnostic Test: shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices

group of Adhesive capsulitis (AC)

30 patients with AC participated in the study

Diagnostic Test: shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices

Interventions

The Biodex System 3 Isokinetic dynamometer was used to measure shoulder abductor, internal rotator and external rotator peak torques and fatigue indices

group of Adhesive capsulitis (AC)healthy control group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In the present study, 60 participants between 40 and 60 years were recruited. They were enrolled in the experimental group, which included 30 typical subjects with unilateral AC and the control group (dominant shoulder) that included 30 healthy individuals of the same age and sex. Individuals were recruited from the outpatient clinics and respective orthopedic centers. They were informed through an advertisement poster placed on the bulletin of the mentioned locations and referred from a physician.

You may qualify if:

  • The AC group included participants that met the following criteria, based on a previous study conducted by Ramirez \[2\] :
  • clinical diagnosis of unilateral AC by an orthopedic specialist, with the limitation of both active and passive glenohumeral ROM, exceeding 25% in at least two of the following planes: flexion, abduction, and external rotation
  • symptom duration between 3 and 12 months
  • no prior surgery to the involved shoulder
  • age between 40 and 60 years. -The control group consisted of healthy individuals of comparable age and sex distribution with no history of shoulder pain, injury, or pathology

You may not qualify if:

  • history of shoulder fracture, dislocation, or surgery;
  • corticosteroid or muscle relaxant use within the previous three months
  • cardiovascular or respiratory conditions that could limit physical testing
  • concurrent participation in structured shoulder strengthening programs
  • inability to perform the isokinetic assessment protocol safely
  • systemic musculoskeletal, neurological or rheumatologic disorders, such as diabetes mellitus, rheumatoid arthritis and cervical radiculopathy. Individuals with diabetes mellitus were excluded due to its well-established association with AC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 12511, Egypt

Location

Related Links

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Azza M, professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 9, 2026

Study Start

February 20, 2015

Primary Completion

November 10, 2016

Study Completion

December 3, 2016

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations