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

Sponsor

University of Cadiz (Other)

Overall Status

Completed

CT.gov ID

NCT03225404

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epicondylitis	Other: Epte group Other: Dry needling group	N/A

Detailed Description

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.

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:

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

Actual Study Start Date :

Jul 18, 2018

Actual Primary Completion Date :

Aug 18, 2018

Actual Study Completion Date :

Sep 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group EPTE + EXER Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.	Other: Epte group Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home. Other Names: EPTE + EXER
Experimental: Control group	Other: Dry needling group The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home. Other Names: DN +EXER

Arm

Intervention/Treatment

Experimental: Experimental group

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

Other: Epte group

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

Other Names:

EPTE + EXER

Experimental: Control group

Other: Dry needling group

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

Other Names:

DN +EXER

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

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 Epte a month earlier

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlínica Santa maría	Cadiz	Cádiz	Spain	11008

Sponsors and Collaborators

University of Cadiz

Investigators

Principal Investigator: Manuel Rodriguez Huguet, Physiotherapy, University of Cadiz

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Manuel Rodriguez Huguet, Clinical Professor, University of Cadiz

ClinicalTrials.gov Identifier:

NCT03225404

Other Study ID Numbers:

UCadiz

First Posted:

Jul 21, 2017

Last Update Posted:

Mar 4, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Manuel Rodriguez Huguet, Clinical Professor, University of Cadiz

Study Results

No Results Posted as of Mar 4, 2022