Bupivacaine or Radiofrequency for Shoulder Pain

NCT05778422 | Completed

• 1 other identifier: Bupivacaine x RF for shoulder
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

shoulder pain; Pulsed radiofrequency; Bipuvacaine; Nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To assess the range of motion of the shoulder joint

  12 months

• Need for additional analgesic.

  12 months

• Duration of the analgesic effect.

  12 months

Study Arms (2)

Pulsed Radiofrequency

ACTIVE COMPARATOR

The investigators performed pulsed radiofrequency in the suprascapular nerve

Procedure: Pulsed radiofrequency

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Suprascapular nerve block with bipuvacaine

Interventions

Suprascapular nerve block with bipuvacaine 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.

Also known as: Suprascapular nerve block with local anesthetic

Bupivacaine

Pulsed radiofrequency 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).

Also known as: Pulsed radiofrequency in suprascapular nerve

Pulsed Radiofrequency

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo - Hospital Sao Paulo

São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Bursitis; Rotator Cuff Injuries

Interventions

Anesthetics, Local; Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group 1 - pulsed radiofrequency Group 2 - bupivacaine

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 21, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)