Bupivacaine or Radiofrequency for Shoulder Pain

NCT ID: NCT05778422

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-01-01

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1 - pulsed radiofrequency Group 2 - bupivacaine
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Pulsed Radiofrequency

The investigators performed pulsed radiofrequency in the suprascapular nerve

Group Type ACTIVE_COMPARATOR

Pulsed radiofrequency

Intervention Type PROCEDURE

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).

Bupivacaine

The investigators performed a blocade with bupivacaine in the suprascapular nerve.

Group Type ACTIVE_COMPARATOR

Suprascapular nerve block with bipuvacaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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).

Intervention Type PROCEDURE

Other Intervention Names

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Suprascapular nerve block with local anesthetic Pulsed radiofrequency in suprascapular nerve

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Henrique Cunha Ferraro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Sao Paulo - Hospital Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Bupivacaine x RF for shoulder

Identifier Type: -

Identifier Source: org_study_id

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