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Recruiting NCT07235982

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

No phase Interventional Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group Group Shoulder anterior capsular block (SHAC), Group intraarticular steroid injection (IASI).
Who it may be relevant to
Registry conditions: Analgesia. Basic parameters: 41 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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).

Interventions

  • 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.
  • Procedure Group intraarticular steroid injection (IASI)
    patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program

Primary outcome measures

  • pain intensity [Time frame: BEFORE STARTING PROCEDURE (0 hour)(baseline)]
  • pain intensity [Time frame: 15 minutes after the procedure]
  • pain intensity [Time frame: first 6 hours postoperative]
  • pain intensity [Time frame: one week after procedure]
  • pain intensity [Time frame: 3 weeks after procedure]
  • pain intensity [Time frame: 6 weeks after procedure]
  • pain intensity [Time frame: 8 weeks after procedure]
Secondary outcome measures (5)
  • 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]
  • Total amount of rescue analgesia [Time frame: first 24 hours]
  • patient's satisfaction [Time frame: 1 week after procedure]
  • Complications of SHAC block [Time frame: 24 hours]
  • PASSIVE AND ACTIVE RANGE OF MOTION [Time frame: at baseline, first week and third week follow up post intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculity of Medicine, Zagazig University — Zagazig

Identifiers

NCT: NCT07235982 · 1593

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗