NCT03225404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

July 17, 2017

Last Update Submit

February 16, 2022

Conditions

Epicondylitis

Keywords

TendinopathyElectrolysisExerciseDry needing

Outcome Measures

Primary Outcomes (1)

  • The intensity of pain in epicondylitis

    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.

    Baseline

Secondary Outcomes (4)

  • The intensity of pain in epicondylitis

    Four and twelve weeks

  • Active elbow range of motion

    Baseline,four and twelve weeks

  • Pressure pain thresholds in epicondylitis trigger points

    Baseline, four and twelve weeks

  • Questionnaire SF 12

    Baseline,four and twelve weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Epte group

Control group

EXPERIMENTAL
Other: Dry needling group

Interventions

Epte groupOTHER

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

Also known as: EPTE + EXER
Experimental group
Dry needling groupOTHER

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

Also known as: DN +EXER
Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with Epte a month earlier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlínica Santa maría

Cadiz, Cádiz, 11008, Spain

Location

Related Publications (4)

  • Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

    PMID: 25122629BACKGROUND

  • Minaya-Munoz F, Medina-Mirapeix F, Valera-Garrido F. Quality measures for the care of patients with lateral epicondylalgia. BMC Musculoskelet Disord. 2013 Oct 30;14:310. doi: 10.1186/1471-2474-14-310.

    PMID: 24172311BACKGROUND

  • Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

    PMID: 19297202BACKGROUND

  • Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.

    PMID: 26649058BACKGROUND

MeSH Terms

Conditions

TendinopathyMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesBehavior

Study Officials

  • Manuel Rodriguez Huguet, Physiotherapy

    University of Cadiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Outcomes assesor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A specialist physician will be diagnosed the epicondylitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

July 18, 2018

Primary Completion

August 18, 2018

Study Completion

September 18, 2018

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations

ES(1)