Bupivacaine or Radiofrequency for Shoulder Pain

Study Overview
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Brief Summary
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Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain

Detailed Description
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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.

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

Conditions
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Shoulder Pain, Rotator Cuff Impingement Syndrome, Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Injuries

Intervention / Treatment
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* Drug: Suprascapular nerve block with bipuvacaine
* Procedure: Pulsed radiofrequency


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 - pulsed radiofrequency Group 2 - bupivacaine
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed Radiofrequency<br>The investigators performed pulsed radiofrequency in the suprascapular nerve | Procedure: Pulsed radiofrequency<br>* 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).<br>* Other names: Pulsed radiofrequency in suprascapular nerve;|
| Active Comparator: Bupivacaine<br>The investigators performed a blocade with bupivacaine in the suprascapular nerve. | Drug: Suprascapular nerve block with bipuvacaine<br>* 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.<br>* Other names: Suprascapular nerve block with local anesthetic;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder pain, Pulsed radiofrequency, Bipuvacaine, Nerve block