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Completed

NCT Number: NCT04729400

Percutaneous Electrolysis and Vacuum Myofascial Therapy deviceTrial.

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.

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Key information

Conditions

Epicondylitis Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica Santa María

Cadiz, Cádiz, 11007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vacuum Myofascial Therapy device

Device

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

physical therapy program

Other

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

Therapeutic Percutaneous Electrolysis

Procedure

Therapeutic Percutaneous Electrolysis

ultrasound pulsatil therapy (US) and massage

Procedure

ultrasound pulsatil therapy (US) and massage

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Active elbow range of motion

    Time frame: Baseline,four and twelve weeks

    Measured by a two branches egoniomter

  3. 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)

  4. Questionnaire SF 12

    Time frame: Baseline,four and twelve weeks

    The multidimensional health related quality of life

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2021
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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