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NCT Number: NCT07235982

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

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.

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Key information

Age range

41 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of Medicine, Zagazig University

Zagazig, Egypt

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Group Shoulder anterior capsular block (SHAC)

Procedure

patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint followed by home exercise program.

Group intraarticular steroid injection (IASI)

Procedure

patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program

Primary outcomes

  1. pain intensity

    Time frame: BEFORE STARTING PROCEDURE (0 hour)(baseline)

    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

  2. pain intensity

    Time frame: 15 minutes after the procedure

    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

  3. pain intensity

    Time frame: first 6 hours postoperative

    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

  4. pain intensity

    Time frame: one week after procedure

    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

  5. pain intensity

    Time frame: 3 weeks after procedure

    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. pain intensity

    Time frame: 6 weeks after procedure

    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

  7. pain intensity

    Time frame: 8 weeks after procedure

    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

Secondary outcomes

  1. Assessment of Shoulder Pain and Disability Index (SPADI)

    Time frame: baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure

    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,

  2. Total amount of rescue analgesia

    Time frame: first 24 hours

    Total amount of rescue analgesia (ibuprofen)

  3. patient's satisfaction

    Time frame: 1 week after procedure

    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)

  4. Complications of SHAC block

    Time frame: 24 hours

    Complications of SHAC block (local anesthetic toxicity, infection, bleeding)

  5. PASSIVE AND ACTIVE RANGE OF MOTION

    Time frame: at baseline, first week and third week follow up post intervention.

    Passive and active shoulder flexion, abduction, and external rotation will be measured using goniometer

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Salem, MD

CONTACT

[email protected]

01099333513 ext. 002

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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