Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy

The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercises and stretching program in patients with chronic lateral epicondyle tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercises program realized of isolated form.

Study Overview

• Status: Unknown
• Conditions: Tendinopathy
• Intervention / Treatment: Other: Group of Dry Needling; Other: Group of Electrolysis; Other: Control Group

Detailed Description

Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic lateral epicondyle tendinopathy.

There take part in this study people of both sexes, with ages between 18 and 65 years, all of them present chronic lateral epicondyle tendinopathy.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza
    • Figueruelas, Zaragoza, Spain, 50639
      • Recruiting
      • Opel España
      • Contact: Rita Mª Galán Díaz, MD; Phone Number: +34660222284; Email: rmgalan@usj.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 65 years.
• Patients diagnosed of chronic lateral epicondyle tendinopathy with a minimum of 3 months of evolution.
• Pain when palpating the lateral epicondyle area.
• Positive test in at least 1 of the following 3 clinical tests: Cozen, Thomson or Mill's
• Have the capacity to perform all clinical tests, understand the study process, and obtain informed consent.

Exclusion Criteria:

• Previous history of direct trauma, fractures, joint instability, surgery or rheumatic alterations of the lateral epicondyle area.
• Full elbow extension limited.
• Alterations at cervical level such as: cervical radiculopathy (C4-C7), degenerative pathology in the cervical spine, exacerbated pain increase with neck movements or cervical compression.
• Symptoms compatible with entrapment of the posterior interosseous nerve.
• NSAID intake the week before the intervention;
• Have received treatment with infiltration in the last year;
• Have received physiotherapy treatment during the last month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group of Dry Needling; They will receive a treatment of dry needling, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching. The needle will get in the relevant zone of treatment. The punction will be realized using Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds	Other: Group of Dry Needling; Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
ACTIVE_COMPARATOR: Group of electrolysis; They will receive a treatment of Intratissue Percutaneous Electrolysis, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching. The needle will get in the relevant zone of treatment. The punction will be realized simulating Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds and 3mA each one.	Other: Group of Electrolysis; Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
SHAM_COMPARATOR: Control Group; They will receive a treatment of punction sham, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching.	Other: Control Group; Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in quality of life by DASH	The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. The DASH Outcome Measure contains one optional, four-item modules intended to measure symptoms and function in workers whose jobs require a high degree of physical performance.	Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, as measured by Visual Analog Scale	Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain.	Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Pressure pain thresholds (PPTs)	Level of pressure tolerated by the patient just before feeling pain. The pressure is done with a digital algometer Type II(Somedic). PPTS will be assessed bilaterally in extensor carpi radialis brevis tendon and tibialis anterior muscle.	Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Pain free grip strength	Grip strength before feeling pain. The tool used is a hydraulic hand dynamometer (Baseline). Subjects will be asked to gradually increase the grip strength while the elbow is extended and pronated and arm alongside of the body. They will be asked to stop when pain is felt. We will take three measures with each elbow.	Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Thickness of the tendon, as measured by ultrasound scan	Tendon structure	Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Hypervascularity, as measured by ultrasound scan	Tendon structure	Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: University of Seville
• Investigators: Principal Investigator: Rita Mª Galán Díaz, MD, Universidad San Jorge; Study Director: Pablo Herrero Gallego, PhD, Universidad San Jorge; Study Director: Cleofas Rodríguez Blanco, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (ACTUAL): June 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Dry needling; Eccentric exercise; ntratissue Percutaneous Electrolysis; Lateral epicondyle
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: C3P_CLET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No