Bupivacaine or Radiofrequency for Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778422
• Other study ID #: Bupivacaine x RF for shoulder
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Impingement Syndrome
• Rotator Cuff Impingement Syndrome
• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Shoulder Pain
• Syndrome

Intervention

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.

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).

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Hospital Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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