Shoulder Anterior Capsular Block and Intraarticular Steroid Injection Versus Intraarticular Steroid Injection for Enhancing Pain Relief in Adhesive Capsulitis

Comparative Study Between Shoulder Anterior Capsular Block Plus Steroid Injection Versus Steroid Injection Alone for Pain Management in Adhesive Capsulitis: A Randomized Trial

Improving pain in the patients with adhesive capsulitis by comparing the effect of combined shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection.

Study Overview

• Status: Recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Group Group Shoulder anterior capsular block (SHAC); Procedure: Group intraarticular steroid injection (IASI)

Detailed Description

Comparing between combined shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection for enhancing pain relief in adhesive capsulitis as regards:

• To measure analgesic parameters including: assessment of pain score by using Visual Analogue Score during 8 weeks follow up in comparison to baseline and total amount of rescue analgesic (ibuprofen) consumption.
• To assess the Shoulder pain and Disability Index
• To record complications of the block (local anesthetic toxicity, infection, bleeding, nerve injury)
• Over all patient's satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Salem, MD; Phone Number: 002 01099333513; Email: dinamaghraby@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt
    • Recruiting
    • Faculity of Medicine, Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients acceptance
• Age: 41-65 years old
• Sex: both sex (males or females).
• Physical status: American Society of Anesthesiologist (ASA) І, II.
• Patients attend orthopedic or pain clinic with complaint of shoulder pain and stiffness. These patients received conservative management of pain with no relief of symptoms for at least 2 weeks.

Exclusion Criteria:

• Shoulder pain due to secondary causes, e.g. acute trauma, fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder.

  • Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
  • Patients with known history of allergy to the study drugs (bupivacaine and methylprednisolone).
  • Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases, uncontrolled diabetes mellitus and thyroid.
  • History of neuropathy in the involved limb or previous revision surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Shoulder anterior capsular block (SHAC); patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint	Procedure: Group Group Shoulder anterior capsular block (SHAC); patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint followed by home exercise program.
Active Comparator: Group intraarticular steroid injection (IASI); patients will receive intraarticular steroid injection of the affected shoulder joint	Procedure: Group intraarticular steroid injection (IASI); patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	BEFORE STARTING PROCEDURE (0 hour)(baseline)
pain intensity	measured by Visual Analogue Scale(VAS) as 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	15 minutes after the procedure
pain intensity	measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	first 6 hours postoperative
pain intensity	measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	one week after procedure
pain intensity	measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	3 weeks after procedure
pain intensity	measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	6 weeks after procedure
pain intensity	measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant	8 weeks after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Shoulder Pain and Disability Index (SPADI)	SPADI contains 13 items that assess two domains - a five item subscale that measures pain and an eight item subscale that measures disability. Each subscale scored 10 ranging from 0 (best) to 10 (worst). It is a self administered, valid questionnaire,	baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure
Total amount of rescue analgesia	Total amount of rescue analgesia (ibuprofen)	first 24 hours
patient's satisfaction	degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)	1 week after procedure
Complications of SHAC block	Complications of SHAC block (local anesthetic toxicity, infection, bleeding)	24 hours
PASSIVE AND ACTIVE RANGE OF MOTION	Passive and active shoulder flexion, abduction, and external rotation will be measured using goniometer	at baseline, first week and third week follow up post intervention.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Dina Salem, MD, Faculty of Medicine, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: adhesive capsulitis; shoulder anterior capsular block; intraarticular steroid injection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Joint Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bursitis; Agnosia
• Other Study ID Numbers: 1593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No