Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

Sponsor

University of Cadiz (Other)

Overall Status

Completed

CT.gov ID

NCT04729400

Collaborator

(none)

Enrollment

Location

Arms

4.7

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epicondylitis	Device: Vacuum Myofascial Therapy device Other: physical therapy program Procedure: Therapeutic Percutaneous Electrolysis Procedure: ultrasound pulsatil therapy (US) and massage	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A specialist physician will be diagnosed the epicondylitisA specialist physician will be diagnosed the epicondylitis

Masking:

Single (Participant)

Masking Description:

Outcomes assesor

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 10, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Oct 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The intensity of pain in epicondylitis [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.

Secondary Outcome Measures

The intensity of pain in epicondylitis [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.
Active elbow range of motion [Baseline,four and twelve weeks]
Measured by a two branches egoniomter
Pressure pain thresholds in epicondylitis trigger points [Baseline, four and twelve weeks]
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)
Questionnaire SF 12 [Baseline,four and twelve weeks]
The multidimensional health related quality of life
Scale PRTEE [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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