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Completed

NCT Number: NCT03225404

Effectiveness of Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia. A Single-Blind Randomized Controlled Trial.

The concept of epicondylitis refers to the manifestation of pain ni the area of insertation of the epicondile muscles, and that it is accompained by limitation funcional.A tendinopathy is characterized as a process of degenaration, 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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica Santa maría

Cadiz, Cádiz, 11008, Spain

About this study

Eccentric exercises of the epicondyle muscles were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the epicondyle muscles. Participants were asked to do a normal flexion extension (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

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 Epte a month earlier

Treatment and study plan

Epte group

Other

Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.

Other names: EPTE + EXER

Dry needling group

Other

The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.

Other names: DN +EXER

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

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Acronym: MRH

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Mar 4, 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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