Clinical trial NCT03572803: Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
Official title: Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendinopathy
Keywords: ntratissue Percutaneous Electrolysis
Dry needling
Eccentric exercise
Lateral epicondyle
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: University of Seville
First posted: 2018-06-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in quality of life by DASH
timeFrame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Secondary outcomes:
measure: Pain, as measured by Visual Analog Scale
timeFrame: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
measure: Pressure pain thresholds (PPTs)
timeFrame: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
measure: Pain free grip strength
timeFrame: Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
measure: Thickness of the tendon, as measured by ultrasound scan
timeFrame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
measure: Hypervascularity, as measured by ultrasound scan
timeFrame: Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Other outcomes:
Locations:
city: Figueruelas
country: Spain
facility: Opel España
state: Zaragoza
Study officials:
affiliation: Universidad San Jorge
name: Rita Mª Galán Díaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad San Jorge
name: Pablo Herrero Gallego, PhD
role: STUDY_DIRECTOR
affiliation: University of Seville
name: Cleofas Rodríguez Blanco, PhD
role: STUDY_DIRECTOR
References: