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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03572803
• Other study ID #: C3P_CLET
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Tendinopathy

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)