Frozen ShoulderNCT05212740
Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
A study testing Corticosteroid and Exercise in people with Frozen Shoulder, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Corticosteroid and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jan 2022to 20 Oct 2022
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between ages 18-60 years
- loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side
- The pain VAS more than 7 (10 in total)
Who cannot join
- bilateral frozen shoulder
- rotator cuff tear
- previous corticosteroid injection at the affected shoulder within 3 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Faculty Medicine
Istanbul, Fatih, 34147
İÜC Sağlık Bilimleri Fakültesi
Istanbul
About this study
The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.
Read the detailed description
After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double blind manner in a 1:1 (participant and investigator) to oral corticosteroids or exercise.
- Conditions
- Frozen Shoulder
- Being tested
- Corticosteroid, Exercise
- Keywords
- frozen shoulder, adhesive capsulitis, corticosteroid, exercise
- Medical subject headings
- Bursitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
The treatment will initiate with a dose of 0.5 mg/kg/day prednisolone for two weeks and the dose will halve in the next two weeks.
ExerciseOther
The exercise program will be performed two times per week for six weeks for 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Experimental | The participants will receive prednisolone for four weeks. Receives: Drug: Corticosteroid |
| Exercise | Active comparator | The participants will receive joint mobilization techniques, stretching and home exercise. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in function on DASH at 6th and 12th week
The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Measured: Baseline,6th week and 12th week
Secondary outcomes (4)
Change from baseline in function on ASES at 6th and 12th week
The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
Measured: Baseline,6th week and 12th week
Change from baseline in range of motion (ROM) at 6th and 12th week
The joint's range of motion is the distance that the joint can extend.
Measured: Baseline,6th week and 12th week
Change from baseline in depression and anxiety on HADS at 6th and 12th week
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring.
Measured: Baseline,6th week and 12th week
Change from baseline in pain on VAS at 6th and 12th week
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Measured: Baseline,6th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start25 Jan 2022
- Primary completion10 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynal YASACI, Istanbul University
- Investigators
- Derya Çelik, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212740
- Sponsor's protocol ID
- Istanbul Unıversity-Cerrahpasa
- Status last verified
- Oct 2022
- First submitted
- 16 Jan 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
- ClinicalTrials.gov ID
- NCT05212740
- Acronym / sponsor ID
- Istanbul Unıversity-Cerrahpasa
- Conditions
- Frozen Shoulder
- Keywords
- frozen shoulder, adhesive capsulitis, corticosteroid, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 28 Jan 2022 (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.
The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.
Detailed description
After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double blind manner in a 1:1 (participant and investigator) to oral corticosteroids or exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Experimental | Drug: CorticosteroidThe participants will receive prednisolone for four weeks. |
| Exercise | Active comparator | Other: ExerciseThe participants will receive joint mobilization techniques, stretching and home exercise. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between ages 18-60 years
- loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side
- The pain VAS more than 7 (10 in total)
Key exclusion criteria (3 listed)
- bilateral frozen shoulder
- rotator cuff tear
- previous corticosteroid injection at the affected shoulder within 3 months
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 |
|---|---|---|
| CorticosteroidThe treatment will initiate with a dose of 0.5 mg/kg/day prednisolone for two weeks and the dose will halve in the next two weeks. | Drug | Corticosteroid |
| ExerciseThe exercise program will be performed two times per week for six weeks for 12 sessions. | Other | Exercise |
Primary outcome
Change from baseline in function on DASH at 6th and 12th week
Time frame: Baseline,6th week and 12th week
The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
4 secondary outcomes
Change from baseline in function on ASES at 6th and 12th week
Time frame: Baseline,6th week and 12th week
Change from baseline in range of motion (ROM) at 6th and 12th week
Time frame: Baseline,6th week and 12th week
Change from baseline in depression and anxiety on HADS at 6th and 12th week
Time frame: Baseline,6th week and 12th week
Change from baseline in pain on VAS at 6th and 12th week
Time frame: Baseline,6th week and 12th week
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 1 Nov 2022.
Related trials for Frozen Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
Frozen Shoulder
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.
Derya Çelik study director
Istanbul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid and Exercise in people with Frozen Shoulder, run by Istanbul University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 3 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Change from baseline in function on DASH at 6th and 12th week (time frame: Baseline,6th week and 12th week). 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 1 Nov 2022.