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Completed

NCT Number: NCT06778577

The Efficacy of Suprascapular Nerve Radiofrequency 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?

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Key information

Conditions

Frozen Shoulder Bursitis Intra-Articular Injection Joint Diseases Musculoskeletal Diseases Radiofrequency Ablation Treatment

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of The Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. The active ROM

    Time frame: 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.

  2. Change of scores of the Shoulder Pain and Disability Index (SPADI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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