Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

Not Applicable

Completed

• Conditions: Epicondylitis
• Interventions: Device: Vacuum Myofascial Therapy device; Other: physical therapy program; Procedure: Therapeutic Percutaneous Electrolysis; Procedure: ultrasound pulsatil therapy (US) and massage

• Registration Number: NCT04729400
• Lead Sponsor: University of Cadiz

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.

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 Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Study Start: 2021-06-10
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pressure pain thresholds in epicondylitis trigger points	Baseline, four and twelve weeks	Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)
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
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.

Trial Locations

Locations (1)

Policlínica Santa María; 🇪🇸 Cadiz, Cádiz, Spain