RFp on Suprascapular N. Versus RFp on Suprascapular N. and Circumflex in the Treatment of Painful Shoulder
Evaluation of Pulsed Radiofrequency on the Suprascapular Nerve Versus Radiofrequency Pulsed on Suprascapular Nerve and Circumflex in the Treatment of Painful Shoulder
1 other identifier
interventional
60
1 country
1
Brief Summary
Pulsed radiofrequency produces more lasting pain relief than use of peripheral blocks or analgesic medication in the treatment of chronic pain. We study the use of pulsed radiofrequency on the suprascapular nerve and the Circumflex nerve and the efficacy of the single technique on suprascapular nerve versus the circumflex and suprascapular combinated technique
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2016
CompletedFirst Submitted
Initial submission to the registry
March 28, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedApril 17, 2018
April 1, 2018
2.1 years
March 28, 2018
April 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of decrease in pain assessment scales (VAS)
Change From Baseline on the VAS
9 MONTHS
Secondary Outcomes (3)
Degree of SPADI scale improvement
9 MONTHS
Improvement in the Constant Murley range of motion scale.
9 MONTHS
Recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
9 MONTHS
Study Arms (2)
Pulsed radiofrequency on SE nerve
OTHERSingle technic
Pulsed radiofrequency on SE + CF nerves
OTHERCombinated technic
Interventions
Echoguided technic
Eligibility Criteria
You may qualify if:
- Frozen shoulder syndrome (adhesive capsulitis) of more than 3 months evolution Massive rotator cuff tear Partial rupture of some tendon of the rotator cuff Arthrosis of the joint Humeral scapular periarthritis Calcifying tendinitis Bursitis Subacromial syndrome operated by shoulder arthroscopy and persistence of pain over 3 months evolution
You may not qualify if:
- Rejection of the realization of the technique Anticoagulation or active coagulopathies Infection at the puncture site Psychopathologies or psychiatric problems Judicial litigation at the beginning of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
José Miguel Esparza Miñana
Valencia, 46013, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JOSÉ MIGUEL ESPARZA MIÑANA, MD
Hospital de Manises
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 28, 2018
First Posted
April 17, 2018
Study Start
November 9, 2016
Primary Completion
December 31, 2018
Study Completion
February 25, 2019
Last Updated
April 17, 2018
Record last verified: 2018-04