RFp on Suprascapular N. Versus RFp on Suprascapular N. and Circumflex in the Treatment of Painful Shoulder

April 13, 2018 updated by: Oscar Diaz-Cambronero, Hospital Universitario La Fe

Evaluation of Pulsed Radiofrequency on the Suprascapular Nerve Versus Radiofrequency Pulsed on Suprascapular Nerve and Circumflex in the Treatment of Painful Shoulder

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Valencia, Spain, 46013
        • Recruiting
        • José Miguel Esparza Miñana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Pulsed radiofrequency on SE nerve
Single technic
Procedure: pulsed radiofrequency
Echoguided technic
Other: Pulsed radiofrequency on SE + CF nerves
Combinated technic
Procedure: pulsed radiofrequency
Echoguided technic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of decrease in pain assessment scales (VAS)
Time Frame: 9 MONTHS
Change From Baseline on the VAS
9 MONTHS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Degree of SPADI scale improvement
Time Frame: 9 MONTHS
Change From Baseline in SPADI scale
9 MONTHS
Improvement in the Constant Murley range of motion scale.
Time Frame: 9 MONTHS
Change From Baseline in Constant Murley range of motion scale
9 MONTHS
Recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
Time Frame: 9 MONTHS
Change From Baseline in DASH scale
9 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario La Fe

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JOSÉ MIGUEL ESPARZA MIÑANA, MD, Hospital de Manises

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESP-RF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

WORK IN PROCESS

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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