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Clinical Trials/NCT05778422
NCT05778422
Completed
Not Applicable

Comparative Study Between Pulsed Radiofrequency in Suprascapular Nerve or Bupivacaine Block for Chronic Shoulder Pain

Federal University of São Paulo1 site in 1 country40 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Pulsed radiofrequency
Conditions
Shoulder Pain
Sponsor
Federal University of São Paulo
Enrollment
40
Locations
1
Primary Endpoint
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
January 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Leonardo Henrique Cunha Ferraro

Professor

Federal University of São Paulo

Eligibility Criteria

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
  • Use of pacemaker

Arms & Interventions

Pulsed Radiofrequency

The investigators performed pulsed radiofrequency in the suprascapular nerve

Intervention: Pulsed radiofrequency

Bupivacaine

The investigators performed a blocade with bupivacaine in the suprascapular nerve.

Intervention: Suprascapular nerve block with bipuvacaine

Outcomes

Primary Outcomes

Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.

Time Frame: 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 Outcomes

  • Need for additional analgesic.(12 months)
  • To assess the range of motion of the shoulder joint(12 months)
  • Duration of the analgesic effect.(12 months)

Study Sites (1)

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