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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03572803
Other study ID # C3P_CLET
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date April 2020

Study information

Verified date March 2018
Source Universidad San Jorge
Contact Rita Mª Galán Díaz, MD
Phone +34660222284
Email rmgalan@usj.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date April 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Spain Opel España Figueruelas Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Universidad San Jorge University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Hypervascularity, as measured by ultrasound scan Tendon structure Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
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