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

Comparison of the Efficacy of Ultrasound-guided Suprascapular Nerve Pulsed Radiofrequency Neuromodulation and Intra-articular Steroid Injection in Frozen Shoulder Treatment

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?

Study Overview

• Status: Completed
• Conditions: Frozen Shoulder; Intra-articular Injection; Radiofrequency Ablation Treatment
• Intervention / Treatment: Procedure: suprascapular nerve radiofrequency group (SCNRFT); Other: intra-articular corticosteroid injection (IACI) group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Department of Algology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: suprascapular nerve radiofrequency group (SCNRFT); SCNRFT+intra-articular steroid and local anesthesic injection with physiotherapy. Suprascapular nerve RFT: Ultrasound-guided SCNRFT 42ºC, 360ms. Ultrasound-guided intraarticular injection with 40mg triamcinolone+3 cc %0.5 bupivacaine. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening)	Procedure: suprascapular nerve radiofrequency group (SCNRFT); SCNRFT is a new choice for treatment of frozen shoulder. The suprascapular nerve is the nerve that is most commonly affected in the condition of a frozen shoulder and it is for this reason that the suprascapular nerve is directly targeted by pulsed radiofrequency treatment. As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to "tag" the nerve accurately without injury to the nerves or vessels.
Active Comparator: intra-articular corticosteroid injection (IACI) group; IACI with physiotherapy. Intra-articular steroid+local anesthesic injection: Receive intra-articular corticosteroid injection. Ultrasound-guided IACI with 3c.c. 0.5% bupivacaine and 40mg triamcinolone. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening)	Other: intra-articular corticosteroid injection (IACI) group; IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of The Visual Analogue Scale (VAS)	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.	baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The active ROM	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.	Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of scores of the Shoulder Pain and Disability Index (SPADI)	The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.	Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: intra-articular injection; frozen shoulder; radiofrequency ablation treatment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis
• Other Study ID Numbers: İ7-492-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No