Suprascapular Nerve PRF for Central Sensitization and Neuropathic Pain

NCT ID: NCT06857409

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2026-01-05

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.

Detailed Description

Chronic shoulder pain is a prevalent musculoskeletal condition affecting quality of life, with an incidence of 18-26% in the general population. Its prevalence has doubled over the past 40 years. Pain sensitization, independent of etiology, is frequently observed in patients with musculoskeletal shoulder pain and can lead to poorer clinical outcomes even after primary disease treatment. Chronic pain development involves both peripheral and central sensitization mechanisms, with central sensitization characterized by amplified pain signaling and reduced inhibitory pathway activity. This can result in pain persistence independent of tissue damage and resistance to treatment.

Conventional treatments for chronic shoulder pain include physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular steroid injections. However, these may not provide sufficient long-term analgesia, and some patients develop treatment-resistant chronic pain. Recently, pulsed radiofrequency (PRF) treatment applied to the suprascapular nerve, responsible for 70% of the sensory innervation of the shoulder joint, has gained attention for its efficacy in reducing both nociceptive and neuropathic pain. PRF modulates neural activity without causing thermal damage and may have the potential to reduce central sensitization. However, its effects on central sensitization and neuropathic pain mechanisms remain insufficiently studied.

This study aims to evaluate the impact of suprascapular nerve 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 examine changes in central sensitization, neuropathic pain, and shoulder function. This study seeks to determine whether PRF can serve as an effective alternative in chronic shoulder pain management by reducing central sensitization and improving quality of life.

Conditions

Shoulder Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

suprascapular nerve pulsed radiofrequency

patients undergoing suprascapular nerve pulsed radiofrequency therapy

pulsed radiofrequency

Intervention Type: 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.

Interventions

pulsed radiofrequency

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gülçin Babaoğlu

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Babaoğlu

Medical doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ERKAN YAVUZ AKÇABOY, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TABED 2-25-949

Identifier Type: -

Identifier Source: org_study_id