Rotator Cuff Tear ArthropathyNCT05785572
Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty
A study testing supraescapular nerve radiofrequency and interescalenic braquial plexus in people with Rotator Cuff Tear Arthropathy and Post Operative Pain, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
The purpuse of this study is to asses if the pulsed radiofrecuency of the supraescapular nerve and accesory nerve have the same or superior efectivity controlling the acute postoperative pain than interscalenic braquial plexus block Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear Arthropathy, Post Operative Pain
- What is being tested?
- supraescapular nerve radiofrequency and interescalenic braquial plexus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 1 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 y.o.
- Cronic pain (more than 3 months) due to rotator cuff arthropathy
- VAS higher than 4
- Decrease Constant score
- Conservative treatment (physiotherapy and NSAIs) unsuccessful
Who cannot join
- psychiatric illness
- drug abuse.
- previous surgeries.
- acute traumatic pathology or ethiology different from rotator cuff arthropathy
- pacemaker
- infectious process
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Maria Carmen Gonzalez Lopez, 0034 675175531, mcglez89@gmail.com
Jesus Garcia Hernandez, 0034 690739292, jesusgciahdez@gmail.com
About this study
Official title: Study on the of Preoperative Analgesia With Radiofrequency of Suprascapular Nerve Versus Intraoperative Interscalene Block on Postoperative Pain in Shoulder Rerverse Arthroplasty Surgery
The purpuse of this study is to asses if the pulsed radiofrecuency of the supraescapular nerve and accesory nerve have the same or superior efectivity controlling the acute postoperative pain than interscalenic braquial plexus block
Read the detailed description
This is a randomized, double-blind trial that compares the effect in postoperative pain of pulsed radiofrecuency of the supraescapular nerve carried out at least two to four weeks before reverse total shoulder arthroplasty surgery with interscalenic braquial plexus block done at the moment of the surgery. All the patients received conventional general anaesthesia and multimodal postoperative analgesia with additional patient-controlled rescue analgesics were prescribed
- Conditions
- Rotator Cuff Tear Arthropathy, Post Operative Pain
- Being tested
- supraescapular nerve radiofrequency, interescalenic braquial plexus
- Keywords
- rotator cuff arthropathy, reverse shoulder arthroplasty, supraescapular nerve radiofrecuency, post operative pain
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraescapular nerve radiofrequencyProcedure or surgery
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
interescalenic braquial plexusProcedure or surgery
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency group | Experimental | Patient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery Receives: Procedure: supraescapular nerve radiofrequency |
| Interscalenic braquial plexus block group | Active comparator | Interscalenic braquial plexus block done at the moment of the surgery. Receives: Procedure: interescalenic braquial plexus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogical scale
Postoperative acute pain measurement. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
Measured: periodical measurements of pain, inmediate preoperative pain up to three months postoperative
Secondary outcomes (1)
Visual analogical scale
chronic pain after surgery. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
Measured: 3 months postop. until 1 year postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- randomized clinical trial with two groups of study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Manuel Lopez Millan, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785572
- Sponsor's protocol ID
- DAP_PIH_20
- Status last verified
- Jun 2022
- First submitted
- 15 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the of Preoperative Analgesia With Radiofrequency of Suprascapular Nerve Versus Intraoperative Interscalene Block on Postoperative Pain in Shoulder Rerverse Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT05785572
- Acronym / sponsor ID
- DAP_PIH_20
- Conditions
- Rotator Cuff Tear Arthropathy, Post Operative Pain
- Keywords
- rotator cuff arthropathy, reverse shoulder arthroplasty, supraescapular nerve radiofrecuency, post operative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 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.
The purpuse of this study is to asses if the pulsed radiofrecuency of the supraescapular nerve and accesory nerve have the same or superior efectivity controlling the acute postoperative pain than interscalenic braquial plexus block
Detailed description
This is a randomized, double-blind trial that compares the effect in postoperative pain of pulsed radiofrecuency of the supraescapular nerve carried out at least two to four weeks before reverse total shoulder arthroplasty surgery with interscalenic braquial plexus block done at the moment of the surgery. All the patients received conventional general anaesthesia and multimodal postoperative analgesia with additional patient-controlled rescue analgesics were prescribed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial with two groups of study
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency group | Experimental | Procedure: supraescapular nerve radiofrequencyPatient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery |
| Interscalenic braquial plexus block group | Active comparator | Procedure: interescalenic braquial plexusInterscalenic braquial plexus block done at the moment of the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 y.o.
- Cronic pain (more than 3 months) due to rotator cuff arthropathy
- VAS higher than 4
- Decrease Constant score
- Conservative treatment (physiotherapy and NSAIs) unsuccessful
Key exclusion criteria (6 listed)
- psychiatric illness
- drug abuse.
- previous surgeries.
- acute traumatic pathology or ethiology different from rotator cuff arthropathy
- pacemaker
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 |
|---|---|---|
| supraescapular nerve radiofrequencysupraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery | Procedure or surgery | Radiofrequency group |
| interescalenic braquial plexussupraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery | Procedure or surgery | Interscalenic braquial plexus block group |
Primary outcome
Visual analogical scale
Time frame: periodical measurements of pain, inmediate preoperative pain up to three months postoperative
Postoperative acute pain measurement. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
1 secondary outcome
Visual analogical scale
Time frame: 3 months postop. until 1 year postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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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.
Jose Manuel Lopez Millan principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraescapular nerve radiofrequency and interescalenic braquial plexus in people with Rotator Cuff Tear Arthropathy and Post Operative Pain, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Apr 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Carmen González López (0034 675175531, mcglez89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogical scale (time frame: periodical measurements of pain, inmediate preoperative pain up to three months postoperative). 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 7 Apr 2023.