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

NCT06778577 | Completed

• 1 other identifier: İ7-492-21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.What is the effectiveness of intra-articular steroid injection in frozen shoulder?
2. 2.What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?
3. 3.Should these two methods be used together in frozen shoulder?

Conditions

Frozen Shoulder; Radiofrequency Ablation Treatment; Intra-articular Injection

Keywords

frozen shoulder; radiofrequency ablation treatment; intra-articular injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The active ROM

  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)

  Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

Study Arms (2)

suprascapular nerve radiofrequency group (SCNRFT)

EXPERIMENTAL

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)

intra-articular corticosteroid injection (IACI) group

ACTIVE COMPARATOR

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

Interventions

intra-articular corticosteroid injection (IACI) group OTHER

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

intra-articular corticosteroid injection (IACI) group

suprascapular nerve radiofrequency group (SCNRFT) 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.

suprascapular nerve radiofrequency group (SCNRFT)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

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

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Interventions

Adrenal Cortex Hormones; Population Groups

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: January 16, 2025
• Study Start: August 15, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 20, 2022
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

TU (1)