NCT07502209

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

March 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Chronic Shoulder PainRotator Cuff Tendinopathy

Keywords

Suprascapular NervePulsed RadiofrequencyChronic Shoulder PainRotator Cuff TendinopathyIsokinetic Muscle StrengthUltrasound MeasurementShoulder Function

Outcome Measures

Primary Outcomes (1)

  • Isokinetic Shoulder Abduction Peak Torque

    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.

    Baseline and 3 months

Secondary Outcomes (5)

  • Pain Intensity (NPRS)

    Baseline, 24 hours, 1 month, and 3 months

  • Shoulder Function (SPADI)

    Baseline, 1 month, and 3 months

  • Supraspinatus and Infraspinatus Muscle Thickness

    Baseline and 3 months

  • Shoulder Range of Motion (ROM)

    Baseline and 3 months

  • Quality of Life (SF-36)

    Baseline and 3 months

Study Arms (2)

Suprascapular Notch PRF

EXPERIMENTAL

Participants in this group will receive pulsed radiofrequency treatment of the suprascapular nerve via the suprascapular notch approach under ultrasound guidance.

Procedure: PRF of the Suprascapular Nerve (Notch Approach)

Midpoint PRF

EXPERIMENTAL

Participants in this group will receive pulsed radiofrequency treatment of the suprascapular nerve via the midpoint approach under ultrasound guidance.

Procedure: PRF of the Suprascapular Nerve (Midpoint Approach)

Interventions

PRF of the Suprascapular Nerve (Notch Approach)PROCEDURE

Pulsed radiofrequency treatment will be applied to the suprascapular nerve via the suprascapular notch approach under ultrasound guidance using standard clinical parameters.

Suprascapular Notch PRF
PRF of the Suprascapular Nerve (Midpoint Approach)PROCEDURE

Pulsed radiofrequency treatment will be applied to the suprascapular nerve via the midpoint approach under ultrasound guidance using standard clinical parameters.

Midpoint PRF

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 41008275BACKGROUND

  • 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: 38988077BACKGROUND

  • 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: 31527162BACKGROUND

Study Officials

  • Ayşe Merve Ata, MD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülberk Özok, MD

CONTACT

5325034077gulberk.koc95@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups using a computerized randomization method based on age and sex. One group will receive pulsed radiofrequency treatment of the suprascapular nerve via the suprascapular notch approach, while the other group will receive the same treatment via the midpoint approach.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 30, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)