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

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: Unknown
• Conditions: Pain Syndrome
• Intervention / Treatment: Procedure: pulsed radiofrequency

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46013
    • Recruiting
    • José Miguel Esparza Miñana
    • Contact: JOSÉ MIGUEL ESPARZA MIÑANA; Phone Number: 627959771; Email: jesparza@hospitalmanises.es

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Degree of decrease in pain assessment scales (VAS)	Change From Baseline on the VAS	9 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of SPADI scale improvement	Change From Baseline in SPADI scale	9 MONTHS
Improvement in the Constant Murley range of motion scale.	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).	Change From Baseline in DASH scale	9 MONTHS

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe
• Investigators: Principal Investigator: JOSÉ MIGUEL ESPARZA MIÑANA, MD, Hospital de Manises

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): February 25, 2019

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: painful shoulder
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain
• Other Study ID 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