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Pulsed Radiofrequency One or Three Nerves for Chronic Shoulder Pain. A Prospective, Randomized, Double-blind Study

NCT04954391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-05-23

No results posted yet for this study

Summary

Pulsed radiofrequency (PRF) neuromodulation / or ablation is an interventional pain management method. Clinical use of PRF for shoulder pain management generally focuses on the suprascapular nerve, what is considered a safe and superior to placebo and physiotherapy. We study the use of the PRF neuromodulation the suprascapular, axillary, and articular branches of the lateral pectoral nerve, as well as the effectiveness of this combined technique compared to the PRF of the suprascapular nerve alone

Conditions

  • Chronic Shoulder Pain

Interventions

PROCEDURE

Pulsed radiofrequency neuromodulation of the suprascapular nerve only

PRF stimulation of the suprascapular nerve under ultrasound navigation in the notch of the scapula using the Cosman G4 apparatus with the introduction of stimulation: sensory: 50 Hz; 1 ms; up to 0.5 V; motor: 2 Hz; 1 ms; voltage - twice the sensory threshold, but not less than 1V; after introduction of 1 ml of 0.75% ropivacaine, PRF is performed: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec. Before removing the cannula, local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg. Under the US navigation, an RF cannula will be placed sequentially at the axillary nerve in the quadrilateral foramen and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation and local administration of 0.75% ropivacaine 1 ml PRF session imitation lasting 480 sec will be carried out. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg

PROCEDURE

Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves

Under ultrasound navigation an RF cannula will be placed sequentially at the suprascapular nerve, at the axillary nerve and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation from RF generator and local administration of 0.75% ropivacaine 1 ml to each nerve, PRF neuromodulation session will be carried out: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec to each nerve. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow to each nerve. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg

Sponsors & Collaborators

  • Saint Petersburg State University, Russia

    lead OTHER

Principal Investigators

  • Konstantin Trukhin · Saint Petersburg State University, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2023-12-30
Completion
2024-04-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954391 on ClinicalTrials.gov