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Bupivacaine or Radiofrequency for Shoulder Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05778422
Enrollment
40
Registered
2023-03-21
Start date
2021-01-01
Completion date
2023-01-01
Last updated
2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

shoulder pain, Pulsed radiofrequency, Bipuvacaine, Nerve block

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.

Interventions

DRUGSuprascapular 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.

PROCEDUREPulsed 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).

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention model description

Group 1 - pulsed radiofrequency Group 2 - bupivacaine

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.12 monthsComparison 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

MeasureTime frameDescription
To assess the range of motion of the shoulder joint12 monthsTo assess the range of motion of the shoulder joint. A goniometer was used to assess the range of motion.
Need for additional analgesic.12 monthsAssessment 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.12 monthsPain 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026