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

NCT ID: NCT03572803

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2020-04-30

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Group of Dry Needling

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Group of Electrolysis

Intervention Type: OTHER

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

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.

Group Type: SHAM_COMPARATOR

Control Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: collaborator

Universidad San Jorge

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Mª Galán Díaz, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad San Jorge

Pablo Herrero Gallego, PhD

Role: STUDY_DIRECTOR

Universidad San Jorge

Cleofas Rodríguez Blanco, PhD

Role: STUDY_DIRECTOR

University of Seville

Locations

Opel España

Figueruelas, Zaragoza, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rita Mª Galán Díaz, MD

Role: CONTACT

rmgalan@usj.es

+34660222284

Pablo Herrero Gallego, PhD

Role: CONTACT

pherrero@usj.es

+976060100

Facility Contacts

Rita Mª Galán Díaz, MD

Role: primary

rmgalan@usj.es

+34660222284

Other Identifiers

C3P_CLET

Identifier Type: -

Identifier Source: org_study_id