Pericapsular vs Intra-Articular Injection in Adhesive Capsulitis

NCT07710651 | Completed

• 1 other identifier: E-83045809-604.01.01-539366
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Ultrasound-Guided Injection; Pericapsular Injection; Intra-Articular Injection; Glenohumeral Joint

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline,1-Hour, Week 1, Week 4, and Month 3

Secondary Outcomes (1)

• Change in Shoulder Disability Questionnaire (SDQ) score

  Baseline, Week 1, Week 4, and Month 3

Study Arms (2)

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.

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.

Drug: Betamethasone

Interventions

Betamethasone DRUG

Ultrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.

Also known as: Lidocaine

Intra-articular Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of unilateral adhesive capsulitis, characterized by shoulder pain and restriction of both active and passive range of motion.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35860100 BACKGROUND

• Buchbinder 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.

  PMID: 15479896 BACKGROUND

• Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.

  PMID: 670287 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Betamethasone; Lidocaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 17, 2026
• Study Start: August 15, 2023
• Primary Completion: December 20, 2023
• Study Completion: March 5, 2024
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)