Adhesive Capsulitis of the ShoulderFrozenShoulderNCT07131839
Central Sensitization Presence on the Results of Shoulder Adhesive Capsulitis
An observational study of Adhesive Capsulitis of the Shoulder, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Patients with adhesive capulitis longlasting more than 3 months were participated in the study. they were divided into two groups whether they have central sensitizaiton or not. Conventional physical therapy responses were measured and compared between two groups. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jun 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adhesive capsulitis patients aged between 18-80 years, and symptoms ongoing more than 3 months were participated in the study
Who may be able to join
- 1)patients with adhesive capsulitis between 18-80 years old 2) symptoms ongoing more than 3 months 3) willing to participated in the study
Who cannot join
- 1) patients with cervical radiculopathy 2) Patients with predisposing factors to adhesive capsulitis, such as diabetes mellitus, thyroid disease, coronary artery disease, lung pathologies or tuberculosis 3) any defined central sensitization syndrome such as fibromiyalgia before 4) presence of rheumatologic diseases 5) pregnancy 6) patients underwent bypass surgery or who have cardiac pacemaker 7) patients with septic arthritis or sepsis 8) malignancy 9) patients that underwent surgery through the shoulder region or had injection through the shoulder joint in the last 3 months.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Central Sensitization Presence on the Results of Shoulder Adhesive Capsulitis Treatment With Physical Therapy Agents and Exercise
Patients with adhesive capulitis longlasting more than 3 months were participated in the study. they were divided into two groups whether they have central sensitizaiton or not. Conventional physical therapy responses were measured and compared between two groups.
Read the detailed description
Adhesive capsulitis is a well known musculoskeletal syndrome that effects daily living activities and patiemts suffer from chronic shoulder pain. Central sensitization has been defined in patients with chronic pain due to amplified neuronal connections and signals in the central nervous system. Previously, it was shown that refractory long lasting musculoskeletal disorders may show challenging treatment process and decreased outcome due to central sensitization. However to the best of our knowledge there was not any study that evaluates the treatment response of presence of central sensitization in adhesive capsulitis patients. Total of 32 adhesive capsulitis patients were particapted in the study. Sixteen patients with adhesive capsulitis with (Group 1) and without central sensitization (Group 2) were received conventional physical therapy and exercise. Treatment response were evaluated with Visual Analog Scale (VAS), Shoulder pain and disability index (SPADI) Tampa Kinesiophobia Scale (TKS) and Pain Catastrophizing Scale (PCS). Additionally shoulder range of motion was measured at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- Adhesive Capsulitis, chronic pain
- Medical subject headings
- Bursitis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Adhesive shoulder patients with central sensitization | |
| Group 2 | Adhesive capsulitis patients without central sensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A 10 cm VAS, with known validity and reliability, was used as a self-reported measure for the severity of joint pain.
Measured: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
Shoulder Pain Disability Index (SPADI)
This questionnaire was developed to assess shoulder joint pain and disability. The SPADI has two sections; first section contains 5 questions to evaluate pain, whereas second item contains 8 questions to evaluate disability. Scores vary 0-130 and higher scores indicates high disability rates and pain
Measured: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
Measurement of Shoulder range of motion
The same physician performed the measurement for the joint ranges in each plane of the joint with a goniometer. The goniometer's pivot point was positioned on the lateral projection of the shoulder joint while subjects in supine position. The fixed arm aligned parallel to the axillary lateral midline , while the movable arm tracked the humerus' lateral midline movement towards the axilla. The joint was passively forced to the end of the direction of range and measured twice and the average was taken
Measured: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
Secondary outcomes (3)
Tampa Kinesiophobia Scale (TKS)
It was used to measure pain and the resulting fear and avoidance of moving the painful body part. TKS contains 17 questions assess parameters of injury/re-injury and fear or avoidance in work-related activities. Scores vary 17-68 and higher scores indicates higher kinseiophobia levels
Measured: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
Pain Catastrophizing Scale (PCS)
PCS was created to evaluate the perception of catastrophizing caused by pain. It provide an objective assessment of the cognitive status related to pain. It consists of a self-administered 13-question and Likert scale (0, means never; 4, means always) is used in scoring. Total score is between 0-52 and with higher scores, perception of catastrophizing increases
Measured: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI) is used to evaluate the characteristics of depression and anxiety. BDI consists of 21 questions, higher scores imply increased depression symptom severity
Measured: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüma Bölük Şenlikci, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131839
- Sponsor's protocol ID
- KA 21/47
- Other IDs
- AnkaraCHBilkent
- Acronym
- FrozenShoulder
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing is going to be considered after submitted to a journal
Publications
Bilika P, Nijs J, Fandridis E, Dimitriadis Z, Strimpakos N, Kapreli E. In the Shoulder or in the Brain? Behavioral, Psychosocial and Cognitive Characteristics of Unilateral Chronic Shoulder Pain with Symptoms of Central Sensitization. Healthcare (Basel). 2022 Aug 30;10(9):1658. doi: 10.3390/healthcare10091658.
PubMed 36141270Brindisino F, Girardi G, Crestani M, Fiore A, Giovannico G, Garzonio F, Venturin D, Struyf F. Effectiveness of electrophysical agents in subjects with frozen shoulder: a systematic review and meta-analysis. Disabil Rehabil. 2024 Aug;46(16):3513-3534. doi: 10.1080/09638288.2023.2251880. Epub 2023 Sep 5.
PubMed 37667875James-Belin E, Lasbleiz S, Haddad A, Morchoisne O, Ostertag A, Yelnik A, Laredo JD, Bardin T, Orcel P, Richette P, Beaudreuil J. Shoulder adhesive capsulitis: diagnostic value of active and passive range of motion with volume of gleno-humeral capsule as a reference. Eur J Phys Rehabil Med. 2020 Aug;56(4):438-443. doi: 10.23736/S1973-9087.19.05890-8. Epub 2019 Nov 18.
PubMed 31742369
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Central Sensitization Presence on the Results of Shoulder Adhesive Capsulitis Treatment With Physical Therapy Agents and Exercise
- ClinicalTrials.gov ID
- NCT07131839
- Acronym / sponsor ID
- FrozenShoulder / KA 21/47
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- Adhesive Capsulitis, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Aug 2025 (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.
Patients with adhesive capulitis longlasting more than 3 months were participated in the study. they were divided into two groups whether they have central sensitizaiton or not. Conventional physical therapy responses were measured and compared between two groups.
Detailed description
Adhesive capsulitis is a well known musculoskeletal syndrome that effects daily living activities and patiemts suffer from chronic shoulder pain. Central sensitization has been defined in patients with chronic pain due to amplified neuronal connections and signals in the central nervous system. Previously, it was shown that refractory long lasting musculoskeletal disorders may show challenging treatment process and decreased outcome due to central sensitization. However to the best of our knowledge there was not any study that evaluates the treatment response of presence of central sensitization in adhesive capsulitis patients. Total of 32 adhesive capsulitis patients were particapted in the study. Sixteen patients with adhesive capsulitis with (Group 1) and without central sensitization (Group 2) were received conventional physical therapy and exercise. Treatment response were evaluated with Visual Analog Scale (VAS), Shoulder pain and disability index (SPADI) Tampa Kinesiophobia Scale (TKS) and Pain Catastrophizing Scale (PCS). Additionally shoulder range of motion was measured at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Adhesive shoulder patients with central sensitization |
| Group 2 | – | –Adhesive capsulitis patients without central sensitization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adhesive capsulitis patients aged between 18-80 years, and symptoms ongoing more than 3 months were participated in the study
Key inclusion criteria (1 listed)
- 1)patients with adhesive capsulitis between 18-80 years old 2) symptoms ongoing more than 3 months 3) willing to participated in the study
Key exclusion criteria (2 listed)
- 1) patients with cervical radiculopathy 2) Patients with predisposing factors to adhesive capsulitis, such as diabetes mellitus, thyroid disease, coronary artery disease, lung pathologies or tuberculosis 3) any defined central sensitization syndrome such as fibromiyalgia before 4) presence of rheumatologic diseases 5) pregnancy 6) patients underwent bypass surgery or who have cardiac pacemaker 7) patients with septic arthritis or sepsis 8) malignancy 9) patients that underwent surgery through the shoulder region or had injection through the shoulder joint in the last 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.
Primary outcome
Visual Analog Scale
Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
A 10 cm VAS, with known validity and reliability, was used as a self-reported measure for the severity of joint pain.
Shoulder Pain Disability Index (SPADI)
Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
This questionnaire was developed to assess shoulder joint pain and disability. The SPADI has two sections; first section contains 5 questions to evaluate pain, whereas second item contains 8 questions to evaluate disability. Scores vary 0-130 and higher scores indicates high disability rates and pain
Measurement of Shoulder range of motion
Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
The same physician performed the measurement for the joint ranges in each plane of the joint with a goniometer. The goniometer's pivot point was positioned on the lateral projection of the shoulder joint while subjects in supine position. The fixed arm aligned parallel to the axillary lateral midline , while the movable arm tracked the humerus' lateral midline movement towards the axilla. The joint was passively forced to the end of the direction of range and measured twice and the average was taken
3 secondary outcomes
Tampa Kinesiophobia Scale (TKS)
Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
Pain Catastrophizing Scale (PCS)
Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).
Beck Depression Inventory (BDI)
Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)
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 20 Aug 2025.
- Results publication: PubMed 36141270Bilika P, Nijs J, Fandridis E, Dimitriadis Z, Strimpakos N, Kapreli E. In the Shoulder or in the Brain? Behavioral, Psychosocial and Cognitive Characteristics of Unilateral Chronic Shoulder Pain with Symptoms of Central Sensitization. Healthcare (Basel). 2022 Aug 30;10(9):1658. doi: 10.3390/healthcare10091658.
- Results publication: PubMed 37667875Brindisino F, Girardi G, Crestani M, Fiore A, Giovannico G, Garzonio F, Venturin D, Struyf F. Effectiveness of electrophysical agents in subjects with frozen shoulder: a systematic review and meta-analysis. Disabil Rehabil. 2024 Aug;46(16):3513-3534. doi: 10.1080/09638288.2023.2251880. Epub 2023 Sep 5.
- Results publication: PubMed 31742369James-Belin E, Lasbleiz S, Haddad A, Morchoisne O, Ostertag A, Yelnik A, Laredo JD, Bardin T, Orcel P, Richette P, Beaudreuil J. Shoulder adhesive capsulitis: diagnostic value of active and passive range of motion with volume of gleno-humeral capsule as a reference. Eur J Phys Rehabil Med. 2020 Aug;56(4):438-443. doi: 10.23736/S1973-9087.19.05890-8. Epub 2019 Nov 18.
- Individual participant dataSharing planned: Undecided. Data sharing is going to be considered after submitted to a journal
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of the Shoulder, run by Ankara City Hospital Bilkent 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 1 inclusion and 2 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 20 Aug 2025. 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?
Visual Analog Scale (time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)). The study lists 3 primary outcomes in all. 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 NCT07131839, which also lists 3 linked publications.
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 20 Aug 2025.