Notch vs Midpoint Suprascapular Nerve PRF for Chronic Shoulder Pain

Официальное название

Comparison of Suprascapular Notch and Midpoint Approaches in Pulsed Radiofrequency Treatment of the Suprascapular Nerve on Pain and Function in Patients With Chronic Shoulder Pain

Обзор

This study aims to compare the effects of pulsed radiofrequency (PRF) treatment of the suprascapular nerve using suprascapular notch and midpoint approaches on pain, shoulder function, and muscle strength in patients with chronic shoulder pain due to rotator cuff tendinopathy. Patients will be randomly assigned to one of the two intervention groups. Clinical evaluations will include pain assessment using the Numeric Rating Scale (NRS), functional assessment using the Shoulder Pain and Disability Index (SPADI), and quality of life assessment using the Short Form-36 (SF-36). In addition, shoulder range of motion will be measured goniometrically, muscle thickness of the supraspinatus and infraspinatus will be evaluated by ultrasonography, and shoulder muscle strength will be assessed using an isokinetic dynamometer. Assessments will be performed at baseline, 24 hours, 1 month, and 3 months after the intervention. The results of this study are expected to provide evidence regarding the optimal approach for PRF treatment of the suprascapular nerve in patients with chronic shoulder pain.

Подробное описание

Chronic shoulder pain is a common musculoskeletal condition that significantly affects daily activities and quality of life. Rotator cuff tendinopathy is one of the most frequent causes of chronic shoulder pain. The suprascapular nerve plays a key role in shoulder pain transmission, and pulsed radiofrequency (PRF) of the suprascapular nerve has emerged as an effective minimally invasive treatment option.

Different anatomical approaches have been described for suprascapular nerve interventions, including the suprascapular notch and midpoint approaches. However, there is limited evidence comparing the clinical and functional outcomes of these approaches.

The aim of this prospective, randomized study is to compare the effects of PRF applied to the suprascapular nerve via suprascapular notch and midpoint approaches in patients with chronic shoulder pain due to rotator cuff tendinopathy. Patients will be randomly allocated into two groups according to the intervention approach.

Clinical evaluations will include pain assessment using the Numeric Rating Scale (NRS), functional evaluation using the Shoulder Pain and Disability Index (SPADI), and quality of life assessment using the Short Form-36 (SF-36). In addition, shoulder range of motion will be measured goniometrically. Muscle thickness of the supraspinatus and infraspinatus will be assessed using ultrasonography, and shoulder muscle strength will be evaluated using an isokinetic dynamometer.

Assessments will be performed at baseline, 24 hours, 1 month, and 3 months following the intervention. The primary outcome of the study is the change in shoulder muscle strength, while secondary outcomes include pain, functional status, and muscle thickness.

The findings of this study are expected to contribute to the literature by identifying the optimal anatomical approach for suprascapular nerve PRF in the management of chronic shoulder pain.

Вмешательства

• Процедура PRF of the Suprascapular Nerve (Notch Approach)
  Under ultrasound guidance, a radiofrequency needle will be positioned adjacent to the suprascapular nerve at the suprascapular notch. Sensory stimulation at 50 Hz and motor stimulation at 2 Hz will be performed to confirm appropriate needle placement. Pulsed radiofrequency will then be applied at 42°C for three cycles of 120 seconds.
• Процедура PRF of the Suprascapular Nerve (Midpoint Approach)
  Under ultrasound guidance, a radiofrequency needle will be positioned adjacent to the suprascapular nerve at the midpoint between the suprascapular notch and the spinoglenoid notch. Sensory stimulation at 50 Hz and motor stimulation at 2 Hz will be performed to confirm appropriate needle placement. Pulsed radiofrequency will then be applied at 42°C for three cycles of 120 seconds.

Первичные конечные точки

• Isokinetic Shoulder Abduction Peak Torque [Срок оценки: Baseline and 3 months]

Вторичные конечные точки (5)

• Pain Intensity (NPRS) [Срок оценки: Baseline, 24 hours, 1 month, and 3 months]
• Shoulder Function (SPADI) [Срок оценки: Baseline, 1 month, and 3 months]
• Supraspinatus and Infraspinatus Muscle Thickness [Срок оценки: Baseline and 3 months]
• Shoulder Range of Motion (ROM) [Срок оценки: Baseline and 3 months]
• Quality of Life (SF-36) [Срок оценки: Baseline and 3 months]

Критерии участия

Критерии включения

• Patients aged between 40 and 80 years
• Patients with chronic shoulder pain lasting longer than 3 months
• Patients diagnosed with rotator cuff-related shoulder pain
• Patients who show at least 50% pain reduction after diagnostic suprascapular nerve block
• Patients who provide written informed consent

Критерии исключения

• Adhesive capsulitis
• Previous shoulder surgery
• Full-thickness rotator cuff tear
• Neurological disorders affecting the shoulder
• Pacemaker
• Coagulopathy or anticoagulant therapy contraindicating intervention
• Infection at the injection site
• Severe systemic disease
• Pregnancy
• Inability to comply with study protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital — Ankara

Публикации

• Abd-Elsayed A, Argall TR, Henjum LJ, McKindsey DM, Perkins NA, Fiala KJ. Radiofrequency Ablation and Pulsed Radiofrequency of Suprascapular Nerves for Managing Chronic Shoulder Pain. Brain Sci. 2025 Aug 26;15(9):915. doi: 10.3390/brainsci15090915. PMID 41008275
• Jain E, O'Connor IT, Tram JK, Varlotta CA, Fiala KJ, Asaad FS, Chitneni A, Abd-Elsayed A. Radiofrequency ablation for shoulder pain: an updated systematic review. Ann Palliat Med. 2024 Jul;13(4):963-975. doi: 10.21037/apm-23-529. Epub 2024 Jul 4. PMID 38988077
• Tran J, Peng P, Agur A. Evaluation of suprascapular nerve radiofrequency ablation protocols: 3D cadaveric needle placement study. Reg Anesth Pain Med. 2019 Sep 16:rapm-2019-100739. doi: 10.1136/rapm-2019-100739. Online ahead of print. PMID 31527162

Идентификаторы

NCT: NCT07502209 · TABED 1-26-2295 · TABED 1-26-2295

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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