Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

February 24, 2022 updated by: Manuel Rodriguez Huguet, University of Cadiz

Percutaneous Electrolysis and Vacuum Myofascial Therapy Device in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.

The concept of epicondylitis refers to the manifestation of pain in the area of insertion of the epicondile muscles, and that it is accompanied by limitation functional. A tendinopathy is characterized as a process of degeneration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Experimental group will be treated Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home and the control group will be included 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • 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 Locations

  • Spain
    • Cádiz
      • Cadiz, Cádiz, Spain, 11007
        • Policlínica Santa María

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution.

Exclusion Criteria:

  • Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with electrolysis and Vacuum Myofascial Therapy Device a month earlier

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.
Device: Vacuum Myofascial Therapy device
Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.
Procedure: Therapeutic Percutaneous Electrolysis
Therapeutic Percutaneous Electrolysis
Experimental: CONTROL GROUP
The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.
Other: physical therapy program
The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.
Procedure: ultrasound pulsatil therapy (US) and massage
ultrasound pulsatil therapy (US) and massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of pain in epicondylitis
Time Frame: Baseline
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of pain in epicondylitis
Time Frame: Four and twelve weeks
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
Four and twelve weeks
Active elbow range of motion
Time Frame: Baseline,four and twelve weeks
Measured by a two branches egoniomter
Baseline,four and twelve weeks
Pressure pain thresholds in epicondylitis trigger points
Time Frame: Baseline, four and twelve weeks
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)
Baseline, four and twelve weeks
Questionnaire SF 12
Time Frame: Baseline,four and twelve weeks
The multidimensional health related quality of life
Baseline,four and twelve weeks
Scale PRTEE
Time Frame: Baseline,four weeks and Twelve weeks.
PRTEE is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area.
Baseline,four weeks and Twelve weeks.

Collaborators and Investigators

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

Sponsor

University of Cadiz

Investigators

  • Principal Investigator: manuel Rodríguez Huguet, Physiotherapy, University of Cádiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 10, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Elctrolysis and vacuum

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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