Bupivacaine or Radiofrequency for Shoulder Pain

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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries; Shoulder Pain; Adhesive Capsulitis; Rotator Cuff Impingement Syndrome; Impingement Syndrome
• Intervention / Treatment: Procedure: Pulsed radiofrequency; Drug: Suprascapular nerve block with bipuvacaine

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04024002
    • Federal University of São Paulo - Hospital São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulsed Radiofrequency; The investigators performed pulsed radiofrequency in the suprascapular nerve	Procedure: Pulsed radiofrequency; After confirming the location, the needle mandrel was removed and the radiofrequency cannula was introduced through the needle, 2ml of 1% lidocaine without epinephrine was injected, followed by application of pulsed radiofrequency for 180sec at 42°C by radiofrequency (radiofrequency generator system BMS-50N, Bramsys).; Other Names: Pulsed radiofrequency in suprascapular nerve
Active Comparator: Bupivacaine; The investigators performed a blocade with bupivacaine in the suprascapular nerve.	Drug: Suprascapular nerve block with bipuvacaine; Suprascapular nerve block with Bipuvacaine: a 50mm 22G needle (Stimuplex, BBraun) was introduced up to the suprascapular fossa, guided by ultrasound, and the location was confirmed by motor stimulation with contraction of the supraspinatus and infraspinatus muscles. Next, 5 ml of 0.25% bupivacaine with adrenaline was injected.; Other Names: Suprascapular nerve block with local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the range of motion of the shoulder joint	To assess the range of motion of the shoulder joint. A goniometer was used to assess the range of motion.	12 months
Need for additional analgesic.	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.	12 months
Duration of the analgesic effect.	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.	12 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: shoulder pain; Nerve block; Pulsed radiofrequency; Bipuvacaine
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Shoulder Pain; Bursitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: Bupivacaine x RF for shoulder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No