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Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04729400
Enrollment
32
Registered
2021-01-28
Start date
2021-06-10
Completion date
2021-10-30
Last updated
2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epicondylitis

Keywords

Tendinopathy, Electrolysis, Exercise, Dry needing, massage, cupping, vacuum, negative pressure

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.

Interventions

DEVICEVacuum Myofascial Therapy device

Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.

OTHERphysical therapy program

The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.

PROCEDURETherapeutic Percutaneous Electrolysis

Therapeutic Percutaneous Electrolysis

PROCEDUREultrasound pulsatil therapy (US) and massage

ultrasound pulsatil therapy (US) and massage

Sponsors

University of Cadiz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Outcomes assesor

Intervention model description

A specialist physician will be diagnosed the epicondylitis

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The intensity of pain in epicondylitisBaselineA 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

MeasureTime frameDescription
The intensity of pain in epicondylitisFour and twelve weeksA 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 motionBaseline,four and twelve weeksMeasured by a two branches egoniomter
Pressure pain thresholds in epicondylitis trigger pointsBaseline, four and twelve weeksPressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)
Questionnaire SF 12Baseline,four and twelve weeksThe multidimensional health related quality of life
Scale PRTEEBaseline,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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026