Shoulder PainNCT05778422
Bupivacaine or Radiofrequency for Shoulder Pain
A study testing Suprascapular nerve block with bipuvacaine and Pulsed radiofrequency in people with Shoulder Pain and Rotator Cuff Impingement Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Rotator Cuff Impingement Syndrome, Impingement Syndrome
- What is being tested?
- Suprascapular nerve block with bipuvacaine and Pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Arrhythmia
- Cognitive change (inability to answer questions)
- Psychiatric illness
- Infection at the site of the procedure
- Coagulopathy,
- Use of anticoagulants
Show all 9Show fewer
- Hypersensitivity to medications
- Pregnant
- Use of pacemaker
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Hospital Sao Paulo
São Paulo, 04024002
About this study
Official title: Comparative Study Between Pulsed Radiofrequency in Suprascapular Nerve or Bupivacaine Block for Chronic Shoulder Pain
Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain
Read the 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.
- Conditions
- Shoulder Pain, Rotator Cuff Impingement Syndrome, Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Injuries
- Being tested
- Suprascapular nerve block with bipuvacaine, Pulsed radiofrequency
- Keywords
- shoulder pain, Pulsed radiofrequency, Bipuvacaine, Nerve block
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Bursitis, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve block with bipuvacaineDrug
Also called Suprascapular nerve block with local anesthetic
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.
Pulsed radiofrequencyProcedure or surgery
Also called Pulsed radiofrequency in suprascapular nerve
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).
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radiofrequency | Active comparator | The investigators performed pulsed radiofrequency in the suprascapular nerve Receives: Procedure: Pulsed radiofrequency |
| Bupivacaine | Active comparator | The investigators performed a blocade with bupivacaine in the suprascapular nerve. Receives: Drug: Suprascapular nerve block with bipuvacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
To assess the range of motion of the shoulder joint
To assess the range of motion of the shoulder joint. A goniometer was used to assess the range of motion.
Measured: 12 months
Need for additional analgesic.
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.
Measured: 12 months
Duration of the analgesic effect.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 - pulsed radiofrequency Group 2 - bupivacaine
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Henrique Cunha Ferraro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778422
- Sponsor's protocol ID
- Bupivacaine x RF for shoulder
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Pulsed Radiofrequency in Suprascapular Nerve or Bupivacaine Block for Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT05778422
- Acronym / sponsor ID
- Bupivacaine x RF for shoulder
- Conditions
- Shoulder Pain, Rotator Cuff Impingement Syndrome, Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Injuries
- Keywords
- shoulder pain, Pulsed radiofrequency, Bipuvacaine, Nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1 - pulsed radiofrequency Group 2 - bupivacaine
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency | Active comparator | Procedure: Pulsed radiofrequencyThe investigators performed pulsed radiofrequency in the suprascapular nerve |
| Bupivacaine | Active comparator | Drug: Suprascapular nerve block with bipuvacaineThe investigators performed a blocade with bupivacaine in the suprascapular nerve. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- Arrhythmia
- Cognitive change (inability to answer questions)
- Psychiatric illness
- Infection at the site of the procedure
- Coagulopathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprascapular nerve block with bipuvacaineAlso: Suprascapular nerve block with local anestheticSuprascapular 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. | Drug | Bupivacaine |
| Pulsed radiofrequencyAlso: Pulsed radiofrequency in suprascapular nerveAfter 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). | Procedure or surgery | Pulsed Radiofrequency |
Primary outcome
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.
3 secondary outcomes
To assess the range of motion of the shoulder joint
Time frame: 12 months
Need for additional analgesic.
Time frame: 12 months
Duration of the analgesic effect.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular nerve block with bipuvacaine and Pulsed radiofrequency in people with Shoulder Pain and Rotator Cuff Impingement Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.