Bupivacaine or Radiofrequency for Shoulder Pain

Not Applicable

Completed

• Conditions: Rotator Cuff Injuries; Shoulder Pain; Rotator Cuff Impingement Syndrome; Adhesive Capsulitis; Impingement Syndrome
• Interventions: Procedure: Pulsed radiofrequency; Drug: Suprascapular nerve block with bipuvacaine

• Registration Number: NCT05778422
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain

Detailed Description

Prospective, randomized, comparative study of 40 participants with chronic shoulder pain allocated into two groups. Patients in group 1 underwent pulsed RF (180sec, with a fixed temperature at 42C, twice) on the suprascapular nerve, and the other group, 2, underwent nerve block with bupivacaine (5ml). After the procedure, patients were evaluated for 3 months regarding pain intensity, shoulder range of motion and dose of rescue opioids.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-01-27
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-21
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age over 18 years old
• Chronic shoulder pain (more than 3 months)
• Clinical and imaging diagnosis: rotator cuff injury, adhesive capsulitis, supraspinatus, tendinopathy, bicipital tendinitis, impingement syndrome, subscapularis tendinopathy, , subacromial and subdeltoid arthrosis, acromioclavicular arthrosis, subdeltoid subacromial bursitis
• Pain intensity ≥4 on movement, on a numerical scale from zero to 10 (where zero means no pain and 10 the most intense pain imaginable).

Exclusion Criteria

• Arrhythmia
• Cognitive change (inability to answer questions)
• Psychiatric illness
• Infection at the site of the procedure
• Coagulopathy,
• Use of anticoagulants
• Hypersensitivity to medications
• Pregnant
• Use of pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed Radiofrequency	Pulsed radiofrequency	The investigators performed pulsed radiofrequency in the suprascapular nerve
Bupivacaine	Suprascapular nerve block with bipuvacaine	The investigators performed a blocade with bupivacaine in the suprascapular nerve.

Primary Outcome Measures

Name	Time	Method
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.	12 months	Comparison of pain intensity after application of pulsed RF to the suprascapular nerve and after injection of a local anesthetic. The numerical pain scale (Visual Analogue Scale - VAS) at rest and during movement was used. This scale (VAS) ranges from 1 to 10, with 1 representing mild pain and 10 representing severe pain.

Secondary Outcome Measures

Name	Time	Method
Need for additional analgesic.	12 months	Assessment of the need for additional analgesics according to pain. Pain was measured using the Visual Analogue Scale, ranging from 1 to 10, with 1 representing mild pain and 10 representing severe pain.
To assess the range of motion of the shoulder joint	12 months	To assess the range of motion of the shoulder joint. A goniometer was used to assess the range of motion.
Duration of the analgesic effect.	12 months	Pain was assessed using the numerical pain scale (Visual Analogue Scale - VAS). The participant was asked to respond on a scale of 1 to 10, with 1 representing mild pain and 10 representing severe pain.

Trial Locations

Locations (1)

Federal University of Sao Paulo - Hospital Sao Paulo; 🇧🇷 Sao Paulo, Brazil