- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225404
Effectiveness of Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia. A Single-Blind Randomized Controlled Trial. (MRH)
February 16, 2022 updated by: Manuel Rodriguez Huguet, University of Cadiz
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cádiz
-
Cadiz, Cádiz, Spain, 11008
- Policlínica Santa María
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control group
|
The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.
Other Names:
|
Experimental: Experimental group
EPTE + EXER Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.
|
Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Four and twelve weeks
|
Active elbow range of motion
Time Frame: Baseline,four and twelve weeks
|
Measured by a two branches egoniomter
|
Baseline,four and twelve weeks
|
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)
|
Baseline, four and twelve weeks
|
Questionnaire SF 12
Time Frame: Baseline,four and twelve weeks
|
The multidimensional health related quality of life
|
Baseline,four and twelve weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: manuel Rodríguez Huguet, Physiotherapy, University of Cadiz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2018
Primary Completion (Actual)
August 18, 2018
Study Completion (Actual)
September 18, 2018
Study Registration Dates
First Submitted
July 17, 2017
First Submitted That Met QC Criteria
July 19, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
March 4, 2022
Last Update Submitted That Met QC Criteria
February 16, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UCadiz
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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