The Efficacy of Suprascapular Nerve Radiofrequency and Intra-articular Steroid Injection in Frozen Shoulder Treatment

Not Applicable

Completed

• Conditions: Frozen Shoulder; Radiofrequency Ablation Treatment; Intra-articular Injection

• Registration Number: NCT06778577
• Lead Sponsor: Ankara University

Brief Summary

The aim of this clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are:

1. What is the effectiveness of intra-articular steroid injection in frozen shoulder?

2. What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?

3. Should these two methods be used together in frozen shoulder?

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-15
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-20
• Study First Submitted: 2024-11-25
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-12
• Last Update Submitted: 2025-01-12
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• unilateral side involvement.
• ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
• duration of symptoms ≥3 months.
• age≥ 20year old.
• Patients with VAS ≥4 before the procedure

Exclusion Criteria

• ever received manipulation of the affected shoulder with/without anesthesia. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
• neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
• pain or disorders of the cervical spine, elbow, wrist, or hand.
• a history of drug allergy to local or corticosteroids.
• Pregnancy or lactation.
• Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.
• Patients with VAS <4 before the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of The Visual Analogue Scale (VAS)	baseline and at 4 weeks and 12 weeks after the beginning of the treatment.	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.

Secondary Outcome Measures

Name	Time	Method
The active ROM	Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.	The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.
Change of scores of the Shoulder Pain and Disability Index (SPADI)	Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.	The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.

Trial Locations

Locations (1)

Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Department of Algology; 🇹🇷 Ankara, Turkey