Suprascapular Nerve PRF for Central Sensitization and Neuropathic Pain

NCT06857409 | Active Not Recruiting DMC

• 1 other identifier: TABED 2-25-949
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic shoulder pain affects quality of life and is often associated with central sensitization, leading to treatment resistance. Pulsed radiofrequency (PRF) of the suprascapular nerve, which innervates 70% of the shoulder joint, is a promising therapy for nociceptive and neuropathic pain. This study evaluates the effects of PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to determine PRF's potential in reducing central sensitization and improving shoulder function.

Conditions

Shoulder Pain

Keywords

shoulder pain; suprascapular nerve; radiofrequency; central sensitization; neuropatic pain

Outcome Measures

Primary Outcomes (1)

• Central Sensitization Inventory (CSI)

  The CSI will be used to assess symptoms related to CS. The CSI will consist of two parts, Part A and Part B. Part A will include 25 items scored on a scale from 0 to 100, with higher scores indicating an increased CS-related symptom burden. In Part B, diagnoses of central sensitivity syndromes will be questioned, and this part will not be included in the scoring.

  baseline, 1st and 3rd months

Secondary Outcomes (3)

• Douleur Neuropathique 4 (DN4) Questionnaire

  baseline, 1st and 3rd months

• Numerical Rating Scale (NRS)

  baseline, 1st and 3rd months

• Shoulder Pain and Disability Index (SPADI)

  baseline, 1st and 3rd months

Study Arms (1)

suprascapular nerve pulsed radiofrequency

patients undergoing suprascapular nerve pulsed radiofrequency therapy

Procedure: pulsed radiofrequency

Interventions

pulsed radiofrequency PROCEDURE

All patients will be monitored with electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation, and peripheral intravenous vascular access will be performed before the procedure. Patients will be placed in a sitting position. The physician will stand behind the patient for the posterior approach. The skin area to be injected will be prepared and covered in a sterile manner using a povidone-iodine-based solution. The operator will use ultrasound (a TOSHIBA Aplio 500 Ultrasound) guidance to perform suprascapular nerve radiofrequency. The suprascapular notch will be visualized. A twenty-two gauge, 10 cm long, and 10 mm active-tipped radiofrequency cannula will be introduced to the suprascapular notch. Motor stimulation will be performed at 2 Hz at a setting of 1 V, and sensory stimulation will be performed at 50 Hz at a setting of 0.5 V. After the needle tip confirmation, pulsed radiofrequency will be applied to the suprascapular nerve for 360 seconds.

suprascapular nerve pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic shoulder pain persisting for at least 3 months

You may qualify if:

• Chronic shoulder pain persisting for at least 3 months
• Radiologically confirmed shoulder lesions, including:
• Rotator cuff tendinopathy Adhesive capsulitis Bursitis Osteoarthritis
• At least two positive provocation tests (Neer, Hawkins, Jobe tests)
• Shoulder pain resistant to conservative treatments, including:
• Nonsteroidal anti-inflammatory drugs (NSAIDs) Physical therapy Corticosteroid injections

You may not qualify if:

• Traumatic shoulder pain (e.g., fractures, dislocations)
• History of shoulder surgery
• Active inflammation or rheumatic diseases affecting the shoulder, including:
• Rheumatoid arthritis Polymyalgia rheumatica Ankylosing spondylitis
• Cervical radiculopathy
• Central nervous system diseases, such as:
• Multiple sclerosis Stroke Spinal cord injury

Sponsors & Collaborators

• Gülçin Babaoğlu: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• ERKAN YAVUZ AKÇABOY, Prof. Dr.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: February 27, 2025
• Primary Completion: October 1, 2025
• Study Completion: May 5, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-02

Locations

TU (1)