RFp on Suprascapular N. Versus RFp on Suprascapular N. and Circumflex in the Treatment of Painful Shoulder
Primary Purpose
Pain Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
pulsed radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Pain Syndrome focused on measuring painful shoulder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- José Miguel Esparza MiñanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pulsed radiofrequency on SE nerve
Pulsed radiofrequency on SE + CF nerves
Arm Description
Single technic
Combinated technic
Outcomes
Primary Outcome Measures
Degree of decrease in pain assessment scales (VAS)
Change From Baseline on the VAS
Secondary Outcome Measures
Degree of SPADI scale improvement
Change From Baseline in SPADI scale
Improvement in the Constant Murley range of motion scale.
Change From Baseline in Constant Murley range of motion scale
Recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
Change From Baseline in DASH scale
Full Information
NCT ID
NCT03498976
First Posted
March 28, 2018
Last Updated
April 13, 2018
Sponsor
Hospital Universitario La Fe
1. Study Identification
Unique Protocol Identification Number
NCT03498976
Brief Title
RFp on Suprascapular N. Versus RFp on Suprascapular N. and Circumflex in the Treatment of Painful Shoulder
Official Title
Evaluation of Pulsed Radiofrequency on the Suprascapular Nerve Versus Radiofrequency Pulsed on Suprascapular Nerve and Circumflex in the Treatment of Painful Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
February 25, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
The painful shoulder is responsible for approximately 16% of all musculoskeletal complaints, constituting one of the most frequent consultations in primary care only behind patients with low back and neck pain.
It has been estimated that 20% of the general population will suffer shoulder pain throughout their lives with a prevalence that can reach up to 50%. It is more prevalent in the elderly with 21% and up to 20% in diabetic patients.
The "painful shoulder syndrome" is a frequent and disabling pathology, of diverse etiology and complex diagnosis, being more common in the female population, and especially from the fifth decade of life in an age range between 45-65 years, although it may manifest itself in other age groups. The prevalence increases with age, some professions and certain sports activities.
Between 70% and 85% of consultations are due to rotator cuff pathology, the most frequent cause of shoulder pain being inflammation of the tendons that form it (supraspinatus, subscapularis, infraspinatus, teres minor and the long portion of the biceps). These are extra-articular muscles, so the clinical picture is called scapulohumeral periarthritis.
Objectives:
Main objective To evaluate the degree of decrease in pain assessment scales (VAS) and decrease in disability scale (SPADI).
Secondary objectives I. Measure the time during which the patient improves pain. II. Evaluate the improvement in the Constant Murley range of motion scale. III. Analyze the recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
IV. Analyze the decrease in the need for analgesic medication (NSAIDs and opiates).
V. Assess the appearance of complications related to the performance of pulsed radiofrequency guided with ultrasound.
Study design The patients were evaluated following the usual protocol of the Pain Unit in which all demographic data, age, sex, reason for consultation, personal history, history of pain, exploration and proposed treatment as well as the complementary tests performed were collected. With the clinical judgment of painful shoulder syndrome, if it met at least one inclusion criterion (table), the patient was exposed to the therapeutic possibilities and the possibility of entering the study.
Subsequently, in a period of no more than 30 days, the interventionist technique is performed in the Pain Unit technique room. Finally, a clinical follow-up is carried out in consultation with the Pain Unit at month, three months, six months and nine months from the date of completion of the technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Syndrome
Keywords
painful shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulsed radiofrequency on SE nerve
Arm Type
Other
Arm Description
Single technic
Arm Title
Pulsed radiofrequency on SE + CF nerves
Arm Type
Other
Arm Description
Combinated technic
Intervention Type
Procedure
Intervention Name(s)
pulsed radiofrequency
Intervention Description
Echoguided technic
Primary Outcome Measure Information:
Title
Degree of decrease in pain assessment scales (VAS)
Description
Change From Baseline on the VAS
Time Frame
9 MONTHS
Secondary Outcome Measure Information:
Title
Degree of SPADI scale improvement
Description
Change From Baseline in SPADI scale
Time Frame
9 MONTHS
Title
Improvement in the Constant Murley range of motion scale.
Description
Change From Baseline in Constant Murley range of motion scale
Time Frame
9 MONTHS
Title
Recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
Description
Change From Baseline in DASH scale
Time Frame
9 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JOSÉ MIGUEL ESPARZA MIÑANA, MD
Phone
627959771
Email
jesparza@hospitalmanises.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSÉ MIGUEL ESPARZA MIÑANA, MD
Organizational Affiliation
Hospital de Manises
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Miguel Esparza Miñana
City
Valencia
ZIP/Postal Code
46013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSÉ MIGUEL ESPARZA MIÑANA
Phone
627959771
Email
jesparza@hospitalmanises.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
WORK IN PROCESS
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RFp on Suprascapular N. Versus RFp on Suprascapular N. and Circumflex in the Treatment of Painful Shoulder
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