NCT07302490

Brief Summary

This study aims to compare the clinical effectiveness of two interventional treatments for chronic shoulder pain related to suprascapular nerve pathology: ultrasound-guided suprascapular nerve block and suprascapular nerve radiofrequency ablation (RFA). A total of 104 patients with chronic shoulder pain were enrolled and assigned to one of the two treatment groups. Participants were evaluated at baseline, 1 month, and 3 months after the intervention. Outcome measures included pain intensity, functional disability, range of motion, kinesiophobia, quality of life, shoulder proprioception, and supraspinatus muscle and tendon thickness measured by ultrasound. The primary aim of the study is to determine whether radiofrequency ablation provides more sustained pain relief and functional improvement compared with nerve block. The findings may help guide clinical decision-making in the management of chronic shoulder pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 11, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

Suprascapular nervePulsed radiofrequencyPRFSuprascapular nerve blockShoulder painChronic painUltrasound-guided interventionsCorticosteroid injectionLocal anesthetic injectionShoulder proprioception

Outcome Measures

Primary Outcomes (1)

  • Change in Shoulder Pain Intensity (VAS Score)

    Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10. The primary outcome is the change in pain score from baseline to 3 months between the PRF group and the nerve block group. Higher scores indicate greater pain intensity.

    Baseline, 1 month and 3 months after the intervention

Secondary Outcomes (6)

  • SPADI (Shoulder Pain and Disability Index) Score

    Baseline, 1 month, 3 months

  • SF-12 (Short Form-12 Health Survey: PCS & MCS)

    Baseline, 1 month, 3 months

  • Tampa Scale for Kinesiophobia

    Baseline, 1 month, 3 months

  • Change in Shoulder Proprioception

    Baseline, 1 month, 3 months

  • Change in Supraspinatus Muscle and Tendon Thickness

    Baseline, 1 month, 3 months

  • +1 more secondary outcomes

Study Arms (2)

PRF Group

ACTIVE COMPARATOR

Participants undergo a single-session pulsed radiofrequency (PRF) procedure applied to the suprascapular nerve under ultrasound guidance. PRF is delivered at a maximum temperature of 42°C for a total of 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine is injected into the perineural area.

Procedure: Pulsed Radiofrequency (PRF) of the Suprascapular Nerve

Nerve Block Group

ACTIVE COMPARATOR

Participants receive suprascapular nerve block under ultrasound guidance consisting of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate injected into the perineural area.

Procedure: Suprascapular Nerve Block with Local Anesthetic and Corticosteroid

Interventions

Injection of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate into the perineural area under ultrasound guidance.

Nerve Block Group

Single-session PRF applied to the suprascapular nerve under ultrasound guidance. PRF is delivered at 42°C for 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine is injected into the perineural area.

PRF Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75 years, male or female. Presence of shoulder pain and/or mobility limitation for at least 3 months. Failure to benefit from medical treatment and exercise-based conservative therapy.
  • Voluntary participation and ability to provide written informed consent for enrollment in the study.

You may not qualify if:

  • Age younger than 18 years or older than 75 years. Shoulder pain caused by non-shoulder conditions such as cervical radiculopathy or myofascial pain syndrome.
  • Presence of severe chronic respiratory disease. History of intra-articular, peri-articular, or suprascapular nerve injection, or use of physical therapy modalities applied to the affected shoulder within the past 3 months.
  • Diagnosis of fibromyalgia. Presence of complex regional pain syndrome, entrapment neuropathy, or vascular disease affecting the same upper extremity.
  • Coagulopathy or bleeding diathesis. Presence of inflammatory or malignant disease. Severe psychiatric disorder or mental condition impairing cooperation or compliance.
  • Refusal to participate or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder PainChronic Pain

Interventions

Prolactin-Releasing HormoneAnesthetics, LocalAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Hakan Genç, MD

    Ankara Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of two parallel groups: suprascapular nerve pulsed radiofrequency (PRF) or suprascapular nerve block with local anesthetic and corticosteroid. Both interventions are administered once under ultrasound guidance. Follow-up assessments at baseline, 1 month, and 3 months will compare outcomes related to pain, functional disability, range of motion, shoulder proprioception, quality of life, and ultrasound-based measurements of supraspinatus muscle and tendon thickness.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Specialist (Sponsor-Investigator)

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

July 27, 2025

Primary Completion

December 8, 2025

Study Completion

December 8, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study involves identifiable clinical information collected in a single-center setting, and current institutional and national data protection regulations do not allow the external distribution of patient-level datasets. Only aggregated results will be available upon reasonable request.

Locations