Clinical trial

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

NCT05778422

Name

Bupivacaine x RF for shoulder

Description

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

Trial arms

Trial start

2021-01-01

Estimated PCD

2022-01-01

Trial end

2023-01-01

Status

Completed

Treatment

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.

Arms:

Bupivacaine

Other names:

Suprascapular nerve block with local anesthetic

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).

Arms:

Pulsed Radiofrequency

Other names:

Pulsed radiofrequency in suprascapular nerve

Size

Primary endpoint

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

12 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 - pulsed radiofrequency Group 2 - bupivacaine', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-03-22

1 organization

1 product

5 indications

Organization

Federal University of São Paulo

Product

Suprascapular nerve block

Indication

Shoulder Pain

Indication

Rotator Cuff Impingement Syndrome

Indication

Shoulder impingement syndrome

Indication

Frozen Shoulder

Indication

Rotator Cuff Injuries