Adhesive CapsulitisNCT05213351
Two Different Exercise Training in Frozen Shoulder Treatment
A study testing Graded Motor Imagery and Exercise in people with Adhesive Capsulitis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Graded Motor Imagery and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2022to 20 Jul 2023
- 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
- Patients aged >60 years
- Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;
- Patients with ability to follow simple orders; iii)
- Patients with ability to sign to provide informed consent
Who cannot join
- Normal passive ROM
- External ROM < 30
- To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint
- Pain < 3 according to the numbered pain assessment scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment
The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.
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 graded motor imagery or exercise group.
- Conditions
- Adhesive Capsulitis
- Being tested
- Graded Motor Imagery, Exercise
- Keywords
- frozen shoulder, exercise, graded motor imagery
- 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.
Graded Motor ImageryOther
Graded Motor Imagery program will be performed two times a week for six consecutive weeks and will include the following three steps: laterality training, imagined movements, and mirror therapy.
- Right-left discrimination training (lateralization training)
- Imagination of hand movements (motor imagery):
- Mirror therapy Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.
ExerciseOther
Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor İmagery | Experimental | Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises. Receives: Other: Graded Motor Imagery |
| Exercise | Active comparator | Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Measured: Baseline,6th week and 8th week
Secondary outcomes (6)
Change from baseline NPRS at 6th and 8th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Measured: Baseline,6th week and 8th week
Change from baseline range of motion at 6th and 8th week
Range of motion is the capability of a joint to go through its complete spectrum of movements.
Measured: Baseline,6th week and 8th week
Change from baseline QuickDASH at 6th and 8th week
The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Measured: Baseline,6th week and 8th week
Change from baseline two-point discrimination at 6th and 8th week
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.
Measured: Baseline,6th week and 8th week
Change from Pain Catastrophizing Scale at 6th and 8th week
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.
Measured: Baseline,6th week and 8th week
Change from SF-12 at 6th and 8th week
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Measured: Baseline,6th week and 8th 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 Apr 2022
- Primary completion1 Jun 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- 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
- 40 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
- NCT05213351
- Sponsor's protocol ID
- 16.01.2022
- Status last verified
- Jul 2023
- First submitted
- 16 Jan 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yasaci Z, Celik D. Does Integration of Graded Motor Imagery Training Augment the Efficacy of a Multimodal Physiotherapy Program for Patients With Frozen Shoulder? A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):707-716. doi: 10.1097/CORR.0000000000003252. Epub 2024 Sep 17.
PubMed 39436270
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment
- ClinicalTrials.gov ID
- NCT05213351
- Acronym / sponsor ID
- 16.01.2022
- Conditions
- Adhesive Capsulitis
- Keywords
- frozen shoulder, exercise, graded motor imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (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 aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.
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 graded motor imagery or exercise group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded Motor İmagery | Experimental | Other: Graded Motor ImageryGraded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises. |
| Exercise | Active comparator | Other: ExerciseExercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged >60 years
- Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;
- Patients with ability to follow simple orders; iii)
- Patients with ability to sign to provide informed consent
Key exclusion criteria (4 listed)
- Normal passive ROM
- External ROM < 30
- To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint
- Pain < 3 according to the numbered pain assessment scale
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 |
|---|---|---|
| Graded Motor ImageryGraded Motor Imagery program will be performed two times a week for six consecutive weeks and will include the following three steps: laterality training, imagined movements, and mirror therapy. 1. Right-left discrimination training (lateralization training) 2. Imagination of hand movements (motor imagery): 3. Mirror therapy Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc. | Other | Graded Motor İmagery |
| ExerciseTreatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc. | Other | Exercise |
Primary outcome
Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week
Time frame: Baseline,6th week and 8th week
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
6 secondary outcomes
Change from baseline NPRS at 6th and 8th week
Time frame: Baseline,6th week and 8th week
Change from baseline range of motion at 6th and 8th week
Time frame: Baseline,6th week and 8th week
Change from baseline QuickDASH at 6th and 8th week
Time frame: Baseline,6th week and 8th week
Change from baseline two-point discrimination at 6th and 8th week
Time frame: Baseline,6th week and 8th week
Change from Pain Catastrophizing Scale at 6th and 8th week
Time frame: Baseline,6th week and 8th week
Change from SF-12 at 6th and 8th week
Time frame: Baseline,6th week and 8th 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 24 Jul 2023.
- Derived from this study: PubMed 39436270Yasaci Z, Celik D. Does Integration of Graded Motor Imagery Training Augment the Efficacy of a Multimodal Physiotherapy Program for Patients With Frozen Shoulder? A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):707-716. doi: 10.1097/CORR.0000000000003252. Epub 2024 Sep 17.
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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.
Derya Çelik study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery and Exercise in people with Adhesive Capsulitis, run by Istanbul University at 1 site 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 4 inclusion and 4 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 24 Jul 2023. 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 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 The Shoulder Pain and Disability Index at 6th and 8th week (time frame: Baseline,6th week and 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213351, which also lists 1 linked publication.
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 24 Jul 2023.