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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572803
Enrollment
66
Registered
2018-06-28
Start date
2018-04-09
Completion date
2020-04-30
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendinopathy

Keywords

ntratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Lateral epicondyle

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.

Interventions

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.

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.

OTHERControl 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.

Sponsors

University of Seville
CollaboratorOTHER
Universidad San Jorge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in quality of life by DASHPre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)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.

Secondary

MeasureTime frameDescription
Pain, as measured by Visual Analog ScalePre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain.
Pressure pain thresholds (PPTs)Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)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.
Pain free grip strengthPre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)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.
Thickness of the tendon, as measured by ultrasound scanPre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)Tendon structure
Hypervascularity, as measured by ultrasound scanPre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)Tendon structure

Countries

Spain

Contacts

Primary ContactRita Mª Galán Díaz, MD
rmgalan@usj.es+34660222284
Backup ContactPablo Herrero Gallego, PhD
pherrero@usj.es+976060100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026