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

NCT ID: NCT06778577

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2022-10-20

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?

Conditions

Frozen Shoulder; Radiofrequency Ablation Treatment; Intra-articular Injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

suprascapular nerve radiofrequency group (SCNRFT)

Intervention Type: PROCEDURE

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.

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)

Group Type: ACTIVE_COMPARATOR

intra-articular corticosteroid injection (IACI) group

Intervention Type: OTHER

IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Dostalı Alıyev

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Department of Algology

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

İ7-492-21

Identifier Type: -

Identifier Source: org_study_id