Back to resultsBupivacaine or Radiofrequency for Shoulder Pain
Primary Purpose
Shoulder Pain, Rotator Cuff Impingement Syndrome, Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Suprascapular nerve block with bipuvacaine
Pulsed radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring shoulder pain, Pulsed radiofrequency, Bipuvacaine, Nerve block
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 Pregnant Use of pacemaker
Sites / Locations
- Federal University of Sao Paulo - Hospital Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulsed Radiofrequency
Bupivacaine
Arm Description
The investigators performed pulsed radiofrequency in the suprascapular nerve
The investigators performed a blocade with bupivacaine in the suprascapular nerve.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05778422
First Posted
January 27, 2023
Last Updated
March 21, 2023
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05778422
Brief Title
Bupivacaine or Radiofrequency for Shoulder Pain
Official Title
Comparative Study Between Pulsed Radiofrequency in Suprascapular Nerve or Bupivacaine Block for Chronic Shoulder Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Rotator Cuff Impingement Syndrome, Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Injuries
Keywords
shoulder pain, Pulsed radiofrequency, Bipuvacaine, Nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1 - pulsed radiofrequency Group 2 - bupivacaine
Masking
Outcomes Assessor
Masking Description
Participants were allocated to groups using a random sequence of numbers generated by computer using the Randomizer® program (www.random.org). The number of patients and the groups to which they would belong were randomly drawn. These numbers were placed in envelopes numbered from 1 to 40, which were drawn on the day of the consultation.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Radiofrequency
Arm Type
Active Comparator
Arm Description
The investigators performed pulsed radiofrequency in the suprascapular nerve
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
The investigators performed a blocade with bupivacaine in the suprascapular nerve.
Intervention Type
Drug
Intervention Name(s)
Suprascapular nerve block with bipuvacaine
Other Intervention Name(s)
Suprascapular nerve block with local anesthetic
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pulsed radiofrequency
Other Intervention Name(s)
Pulsed radiofrequency in suprascapular nerve
Intervention Description
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).
Primary Outcome Measure Information:
Title
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To assess the range of motion of the shoulder joint
Description
To assess the range of motion of the shoulder joint. A goniometer was used to assess the range of motion.
Time Frame
12 months
Title
Need for additional analgesic.
Description
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.
Time Frame
12 months
Title
Duration of the analgesic effect.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Pregnant
Use of pacemaker
Facility Information:
Facility Name
Federal University of Sao Paulo - Hospital Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04024002
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Bupivacaine or Radiofrequency for Shoulder Pain
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