Adhesive CapsulitisNCT07710651
Pericapsular vs Intra-Articular Injection in Adhesive Capsulitis
A study testing Betamethasone in people with Adhesive Capsulitis and Corticosteroid Injection, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Adhesive capsulitis is a common and disabling shoulder disorder characterized by progressive pain and restricted active and passive range of motion, leading to significant limitations in daily activities and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adhesive Capsulitis, Corticosteroid Injection
- What is being tested?
- Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 5 Mar 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Diagnosis of unilateral adhesive capsulitis, characterized by shoulder pain and restriction of both active and passive range of motion.
Who cannot join
- Secondary glenohumeral joint motion limitation due to inflammatory, degenerative, metabolic, or infectious arthritis.
- History of cerebrovascular accident (stroke).
- History of fracture involving the affected shoulder.
- Presence of any neurological deficit affecting the upper extremity.
- Previous surgery involving the affected shoulder.
- History of shoulder trauma.
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- Pregnancy or breastfeeding.
- Known hypersensitivity or allergic reaction to local anesthetics or corticosteroids used in the study.
- Current use of anticoagulant therapy.
- Active inflammatory or infectious disease.
- Active psychiatric disorder.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus.
- Uncompensated chronic heart, liver, or renal failure.
- Presence of vascular or malignant disease affecting the shoulder region.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa
Istanbul, Fatih, 34093
About this study
Official title: Comparison of the Effectiveness of Ultrasound-Guided Pericapsular and Intra-Articular Steroid Injections in Patients Diagnosed With Adhesive Capsulitis
Adhesive capsulitis is a common and disabling shoulder disorder characterized by progressive pain and restricted active and passive range of motion, leading to significant limitations in daily activities and reduced quality of life. Corticosteroid injections are widely used to relieve pain and improve shoulder function; however, the optimal injection site remains a matter of debate. While ultrasound-guided intra-articular injections are considered a standard treatment, ultrasound-guided pericapsular injections have recently emerged as a potential alternative by targeting the inflamed capsular tissues directly.
The primary objective of this study is to compare the clinical effectiveness of ultrasound-guided pericapsular corticosteroid injection with ultrasound-guided intra-articular corticosteroid injection in patients diagnosed with adhesive capsulitis. The study aims to determine whether one injection technique provides superior improvements in pain, shoulder range of motion, functional status, and patient-reported outcomes.
- Conditions
- Adhesive Capsulitis, Corticosteroid Injection
- Being tested
- Betamethasone
- Keywords
- Ultrasound-Guided Injection, Pericapsular Injection, Intra-Articular Injection, Glenohumeral Joint
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called Lidocaine
Ultrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
BetamethasoneDrug
Also called Lidocaine
Ultrasound-guided pericapsular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Group | Active comparator | Participants in the first group (IA group, n = 17) received an ultrasound-guided intra-articular injection. A mixture of 4 mL of 2% lidocaine and 1 mL of betamethasone was administered for the injection procedure. Receives: Drug: Betamethasone |
| Pericapsular Group | Active comparator | Participants in the first group (IA group, n = 17) received an ultrasound-guided pericapsular injection. A mixture of 4 mL of 2% lidocaine and 1 mL of betamethasone was administered for the injection procedure. Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant-Murley Score
The Constant-Murley Score (CMS) is a validated, clinician-administered instrument used to assess shoulder function. It consists of four domains: pain (15 points), activities of daily living (20 points), range of motion (40 points), and muscle strength (25 points), yielding a total score ranging from 0 to 100. Higher scores indicate better shoulder function and less disability. Changes in the CMS from baseline to each follow-up visit will be used to evaluate treatment effectiveness.
Measured: Baseline, Week 1, Week 4, and Month 3
Change in Numeric Rating Scale (NRS) pain score
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Participants will rate their pain at rest, during the night, and during activity. Changes in NRS scores from baseline to each follow-up visit will be used to evaluate the effectiveness of the interventions in reducing pain.
Measured: Baseline,1-Hour, Week 1, Week 4, and Month 3
Secondary outcomes (1)
Change in Shoulder Disability Questionnaire (SDQ) score
The Shoulder Disability Questionnaire (SDQ) is a validated patient-reported outcome measure used to assess pain-related functional disability in individuals with shoulder disorders. It consists of 16 items evaluating limitations in daily activities experienced during the previous 24 hours. The total score ranges from 0 to 100, with higher scores indicating greater shoulder-related disability. Changes in SDQ scores from baseline to each follow-up visit will be used to assess the effectiveness of the interventions in improving shoulder function and reducing disability.
Measured: Baseline, Week 1, Week 4, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Aug 2023
- Primary completion20 Dec 2023
- Study completion5 Mar 2024
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 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
- Model description
- A prospective double-blinded, randomized trial was performed in patients with AC who were followed at the physical medicine and rehabilitation department of our university hospital.Thirty-four (n = 34) patients between the ages of 18 and 70, having unilateral shoulder pain with limitation of both active and passive range of motion (ROM) of the shoulder joint and diagnosed as AC were enrolled in our study. Thirty-four patients (18 women, 16 men) having a diagnosis of AC and who met the inclusion criteria were randomized into 2 groups. The block randomization method was used for the randomization of the patients who were also blinded to group allocation. Same physiatrist generated the random allocation sequence, enrolled participants, and assigned participants to interventions. In the first group (IA group) (n=17) US guided intraarticular injection was applied while in the second group (LA group) (n=17) US guided pericapsular injection was performed.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Kulaksiz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710651
- Sponsor's protocol ID
- E-83045809-604.01.01-539366
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to protect participant confidentiality and privacy.
Publications
Sharif M, Khan MS, Ahmed TK, Aziz W, Rasheed U, Zammurrad S, Iqbal A, Mumtaz H, Hussain HU, Hasan M, Erum S. Comparison of efficacy three-site versus single-site steroid injections for the treatment of adhesive capsulitis. Ann Med Surg (Lond). 2022 Jun 28;79:104071. doi: 10.1016/j.amsu.2022.104071. eCollection 2022 Jul.
PubMed 35860100Buchbinder R, Hoving JL, Green S, Hall S, Forbes A, Nash P. Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Nov;63(11):1460-9. doi: 10.1136/ard.2003.018218.
PubMed 15479896Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
PubMed 670287
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-Guided Pericapsular and Intra-Articular Steroid Injections in Patients Diagnosed With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07710651
- Acronym / sponsor ID
- E-83045809-604.01.01-539366
- Conditions
- Adhesive Capsulitis, Corticosteroid Injection
- Keywords
- Ultrasound-Guided Injection, Pericapsular Injection, Intra-Articular Injection, Glenohumeral Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 17 Jul 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 is a common and disabling shoulder disorder characterized by progressive pain and restricted active and passive range of motion, leading to significant limitations in daily activities and reduced quality of life. Corticosteroid injections are widely used to relieve pain and improve shoulder function; however, the optimal injection site remains a matter of debate. While ultrasound-guided intra-articular injections are considered a standard treatment, ultrasound-guided pericapsular injections have recently emerged as a potential alternative by targeting the inflamed capsular tissues directly.
The primary objective of this study is to compare the clinical effectiveness of ultrasound-guided pericapsular corticosteroid injection with ultrasound-guided intra-articular corticosteroid injection in patients diagnosed with adhesive capsulitis. The study aims to determine whether one injection technique provides superior improvements in pain, shoulder range of motion, functional status, and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective double-blinded, randomized trial was performed in patients with AC who were followed at the physical medicine and rehabilitation department of our university hospital.Thirty-four (n = 34) patients between the ages of 18 and 70, having unilateral shoulder pain with limitation of both active and passive range of motion (ROM) of the shoulder joint and diagnosed as AC were enrolled in our study. Thirty-four patients (18 women, 16 men) having a diagnosis of AC and who met the inclusion criteria were randomized into 2 groups. The block randomization method was used for the randomization of the patients who were also blinded to group allocation. Same physiatrist generated the random allocation sequence, enrolled participants, and assigned participants to interventions. In the first group (IA group) (n=17) US guided intraarticular injection was applied while in the second group (LA group) (n=17) US guided pericapsular injection was performed.
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Group | Active comparator | Drug: BetamethasoneParticipants in the first group (IA group, n = 17) received an ultrasound-guided intra-articular injection. A mixture of 4 mL of 2% lidocaine and 1 mL of betamethasone was administered for the injection procedure. |
| Pericapsular Group | Active comparator | Drug: BetamethasoneParticipants in the first group (IA group, n = 17) received an ultrasound-guided pericapsular injection. A mixture of 4 mL of 2% lidocaine and 1 mL of betamethasone was administered for the injection procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of unilateral adhesive capsulitis, characterized by shoulder pain and restriction of both active and passive range of motion.
Key exclusion criteria (15 listed)
- Secondary glenohumeral joint motion limitation due to inflammatory, degenerative, metabolic, or infectious arthritis.
- History of cerebrovascular accident (stroke).
- History of fracture involving the affected shoulder.
- Presence of any neurological deficit affecting the upper extremity.
- Previous surgery involving the affected shoulder.
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 |
|---|---|---|
| BetamethasoneAlso: LidocaineUltrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine. | Drug | Intra-articular Group |
| BetamethasoneAlso: LidocaineUltrasound-guided pericapsular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine. | Drug | Pericapsular Group |
Primary outcome
Change in Constant-Murley Score
Time frame: Baseline, Week 1, Week 4, and Month 3
The Constant-Murley Score (CMS) is a validated, clinician-administered instrument used to assess shoulder function. It consists of four domains: pain (15 points), activities of daily living (20 points), range of motion (40 points), and muscle strength (25 points), yielding a total score ranging from 0 to 100. Higher scores indicate better shoulder function and less disability. Changes in the CMS from baseline to each follow-up visit will be used to evaluate treatment effectiveness.
Change in Numeric Rating Scale (NRS) pain score
Time frame: Baseline,1-Hour, Week 1, Week 4, and Month 3
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Participants will rate their pain at rest, during the night, and during activity. Changes in NRS scores from baseline to each follow-up visit will be used to evaluate the effectiveness of the interventions in reducing pain.
1 secondary outcome
Change in Shoulder Disability Questionnaire (SDQ) score
Time frame: Baseline, Week 1, Week 4, and Month 3
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 17 Jul 2026.
- Background: PubMed 35860100Sharif M, Khan MS, Ahmed TK, Aziz W, Rasheed U, Zammurrad S, Iqbal A, Mumtaz H, Hussain HU, Hasan M, Erum S. Comparison of efficacy three-site versus single-site steroid injections for the treatment of adhesive capsulitis. Ann Med Surg (Lond). 2022 Jun 28;79:104071. doi: 10.1016/j.amsu.2022.104071. eCollection 2022 Jul.
- Background: PubMed 15479896Buchbinder R, Hoving JL, Green S, Hall S, Forbes A, Nash P. Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Nov;63(11):1460-9. doi: 10.1136/ard.2003.018218.
- Background: PubMed 670287Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to protect participant confidentiality and privacy.
Related trials for Adhesive Capsulitis
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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Comparative Effects of Niel Asher Technique and Bowen Technique on Pain, Range of Motion and Functional Disability in Patients With Adhesive Capsulitis.
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Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
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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?
A study testing Betamethasone in people with Adhesive Capsulitis and Corticosteroid Injection, run by Istanbul University - Cerrahpasa 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 15 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 17 Jul 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 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 in Constant-Murley Score (time frame: Baseline, Week 1, Week 4, and Month 3). The study lists 2 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 NCT07710651, 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 17 Jul 2026.