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

ConditionAnalgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age41-65
SponsorZagazig University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients acceptance

Age: 41-65 years old

Sex: both sex (males or females).

Physical status: American Society of Anesthesiologist (ASA) І, II.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group Group Shoulder anterior capsular block (SHAC)

    Procedure/Surgery

    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/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group Shoulder anterior capsular block (SHAC)Active comparator 1 intervention
Group B: Group intraarticular steroid injection (IASI)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
BEFORE STARTING PROCEDURE (0 hour)(baseline)
2

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

Time frame
15 minutes after the procedure
3

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

Time frame
first 6 hours postoperative
4

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

Time frame
one week after procedure

Secondary outcomes

1

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,

Time frame
baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure
2

Total amount of rescue analgesia

Total amount of rescue analgesia (ibuprofen)

Time frame
first 24 hours
3

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)

Time frame
1 week after procedure
4

Complications of SHAC block

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

Time frame
24 hours

Other outcomes

Sponsors and contacts

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