Adhesive CapsulitisACNCT07520604
Assessment of Shoulder Peak Torque and Fatigue Index in Individuals With Adhesive Capsulitis
An observational study of Adhesive Capsulitis, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2015to 3 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 12511
About this study
Official title: Biomechanical Assessment of Shoulder Peak Torque and Fatigue Index in Individuals With Adhesive Capsulitis: A Case-Control Study
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.
Read the detailed description
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.The study involved a total of sixty subjects within the age group 40 and 60 years comprising thirty in the recovery phase of AC and thirty healthy controls. The Biodex System 3 Isokinetic dynamometer was used to measure shoulder abductor, internal rotator and external rotator peak torques and fatigue indices.
- Conditions
- Adhesive Capsulitis
- Being tested
- shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices
- Keywords
- Adhesive Capsulitis, frozen shoulder, fatigue index, isokinetic dynamometry, peak torque
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indicesDiagnostic test
The Biodex System 3 Isokinetic dynamometer was used to measure shoulder abductor, internal rotator and external rotator peak torques and fatigue indices
| Study group | Role | What they receive |
|---|---|---|
| healthy control group | 30 healthy controls participated in the study Receives: 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 Receives: Diagnostic Test: shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder abductor peak torque
shoulder abductor isokinetic peak torque
Measured: one year
shoulder internal rotator peak torque
shoulder internal rotator isokinetic peak torque
Measured: one year
shoulder external rotator peak torque
shoulder external rotator isokinetic peak torque
Measured: one year
shoulder abductor fatigue index
shoulder abductor isokinetic fatigue index
Measured: one year
shoulder internal rotator fatigue index
shoulder internal rotator isokinetic fatigue index
Measured: one year
shoulder external rotator fatigue index
shoulder external rotator isokinetic fatigue index
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Feb 2015
- Primary completion10 Nov 2016
- Study completion3 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mohammed, Cairo University
- Investigators
- Azza M, professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520604
- Sponsor's protocol ID
- P.T.REC/012/006256
- Acronym
- AC
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of Shoulder Peak Torque and Fatigue Index in Individuals With Adhesive Capsulitis: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07520604
- Acronym / sponsor ID
- AC / P.T.REC/012/006256
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, frozen shoulder, fatigue index, isokinetic dynamometry, peak torque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 3 Dec 2016 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.The study involved a total of sixty subjects within the age group 40 and 60 years comprising thirty in the recovery phase of AC and thirty healthy controls. The Biodex System 3 Isokinetic dynamometer was used to measure shoulder abductor, internal rotator and external rotator peak torques and fatigue indices.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control group | – | Diagnostic Test: shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices30 healthy controls participated in the study |
| group of Adhesive capsulitis (AC) | – | Diagnostic Test: shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indices30 patients with AC participated in the study |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shoulder abductor, internal rotator and external rotator Isokinetic peak torques and fatigue indicesThe Biodex System 3 Isokinetic dynamometer was used to measure shoulder abductor, internal rotator and external rotator peak torques and fatigue indices | Diagnostic test | group of Adhesive capsulitis (AC), healthy control group |
Primary outcome
shoulder abductor peak torque
Time frame: one year
shoulder abductor isokinetic peak torque
shoulder internal rotator peak torque
Time frame: one year
shoulder internal rotator isokinetic peak torque
shoulder external rotator peak torque
Time frame: one year
shoulder external rotator isokinetic peak torque
shoulder abductor fatigue index
Time frame: one year
shoulder abductor isokinetic fatigue index
shoulder internal rotator fatigue index
Time frame: one year
shoulder internal rotator isokinetic fatigue index
shoulder external rotator fatigue index
Time frame: one year
shoulder external rotator isokinetic fatigue index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Isokinetic characteristics of shoulder rotators in patients with adhesive capsulitisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azza M, professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Capsulitis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder abductor peak torque (time frame: one year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.