- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502209
Suprascapular Nerve PRF in Chronic Shoulder Pain (SUPRA-PRF)
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gülberk Özok, MD
- Phone Number: 5325034077
- Email: gulberk.koc95@gmail.com
Study Locations
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Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Contact:
- Gülberk Özok, MD
- Phone Number: 5325034077
- Email: gulberk.koc95@gmail.com
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Contact:
- Email: gulberk.koc95@gmail.com
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Sub-Investigator:
- Gülberk Özok, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Suprascapular Notch PRF
Participants in this group will receive pulsed radiofrequency treatment of the suprascapular nerve via the suprascapular notch approach under ultrasound guidance.
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Pulsed radiofrequency treatment will be applied to the suprascapular nerve via the suprascapular notch approach under ultrasound guidance using standard clinical parameters.
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Experimental: Midpoint PRF
Participants in this group will receive pulsed radiofrequency treatment of the suprascapular nerve via the midpoint approach under ultrasound guidance.
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Pulsed radiofrequency treatment will be applied to the suprascapular nerve via the midpoint approach under ultrasound guidance using standard clinical parameters.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isokinetic Shoulder Abduction Peak Torque
Time Frame: Baseline and 3 months
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Isokinetic peak torque of shoulder abduction will be measured using an isokinetic dynamometer (ISOMED 2000).
Measurements will be performed to evaluate changes in muscle strength.
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Baseline and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (NPRS)
Time Frame: Baseline, 24 hours, 1 month, and 3 months
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Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
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Baseline, 24 hours, 1 month, and 3 months
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Supraspinatus and Infraspinatus Muscle Thickness
Time Frame: Baseline and 3 months
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Muscle thickness will be measured using ultrasonography to evaluate structural changes in the rotator cuff muscles.
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Baseline and 3 months
|
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Shoulder Range of Motion (ROM)
Time Frame: Baseline and 3 months
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Shoulder joint range of motion will be measured using a goniometer.
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Baseline and 3 months
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Shoulder Function (SPADI)
Time Frame: Baseline, 1 month, and 3 months
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Shoulder Pain and Disability Index (SPADI) will be used to assess pain and functional status.
SPADI is a validated questionnaire consisting of 13 items with a total score ranging from 0 to 100, where higher scores indicate greater pain and disability (worse outcome).
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Baseline, 1 month, and 3 months
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Quality of Life (SF-36)
Time Frame: Baseline and 3 months
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Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire.
SF-36 consists of 8 domains, each scored from 0 to 100, where higher scores indicate better health status (better outcome).
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Baseline and 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşe Merve Ata, MD, Ankara City Hospital Bilkent
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TABED 1-26-2295 (Other Identifier: Ethics Committee of Ankara Bilkent City Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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