Comparative Study Between Shoulder Anterior Capsular Block Plus Steroid Injection Versus Steroid Injection Alone for Pain Management in Adhesive Capsulitis: A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Zagazig University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- pain intensity
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcome assessors are blind to the study groups
Eligibility Criteria
- Ages
- 41 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group Shoulder anterior capsular block (SHAC)
patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint
Intervention: Group Group Shoulder anterior capsular block (SHAC) (Procedure)
Group intraarticular steroid injection (IASI)
patients will receive intraarticular steroid injection of the affected shoulder joint
Intervention: Group intraarticular steroid injection (IASI) (Procedure)
Outcomes
Primary Outcomes
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
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
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
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
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
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
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
- Assessment of Shoulder Pain and Disability Index (SPADI)(baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure)
- Total amount of rescue analgesia(first 24 hours)
- patient's satisfaction(1 week after procedure)
- Complications of SHAC block(24 hours)
- PASSIVE AND ACTIVE RANGE OF MOTION(at baseline, first week and third week follow up post intervention.)
Investigators
Dina Abdelhameed Elsadek Salem
principle investigator
Zagazig University