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NCT Number: NCT05778422

Bupivacaine or Radiofrequency for Shoulder Pain

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

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Key information

Conditions

Shoulder Pain Adhesive Capsulitis Arthralgia Bursitis Impingement Syndrome Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Impingement Syndrome Rotator Cuff Injuries Rupture Shoulder Impingement Syndrome Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo - Hospital Sao Paulo

São Paulo, 04024002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Suprascapular nerve block with local anesthetic

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).

Other names: Pulsed radiofrequency in suprascapular nerve

Primary outcomes

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

    Time frame: 12 months

    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.

Secondary outcomes

  1. To assess the range of motion of the shoulder joint

    Time frame: 12 months

    To assess the range of motion of the shoulder joint. A goniometer was used to assess the range of motion.

  2. Need for additional analgesic.

    Time frame: 12 months

    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.

  3. Duration of the analgesic effect.

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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