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

NCT03572803 | Unknown DMC

• 1 other identifier: C3P_CLET
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain, as measured by Visual Analog Scale

  Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)

• Pressure pain thresholds (PPTs)

  Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)

• Pain free grip strength

  Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)

• Thickness of the tendon, as measured by ultrasound scan

  Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)

• Hypervascularity, as measured by ultrasound scan

  Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)

Study Arms (3)

Group of Dry Needling

ACTIVE COMPARATOR

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

Other: Group of Dry Needling

Group of electrolysis

ACTIVE COMPARATOR

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.

Other: Group of Electrolysis

Control Group

SHAM COMPARATOR

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.

Other: Control Group

Interventions

Group of Dry Needling 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 Dry Needling

Group of Electrolysis 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

Control Group 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad San Jorge: lead
• University of Seville: collaborator

Study Sites (1)

Opel España

Figueruelas, Zaragoza, 50639, Spain

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rita Mª Galán Díaz, MD

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

• Pablo Herrero Gallego, PhD

  Universidad San Jorge

  STUDY DIRECTOR

• Cleofas Rodríguez Blanco, PhD

  University of Seville

  STUDY DIRECTOR

Central Study Contacts

Rita Mª Galán Díaz, MD

CONTACT

+34660222284; rmgalan@usj.es

Pablo Herrero Gallego, PhD

CONTACT

+976060100; pherrero@usj.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 28, 2018
• Study Start: April 9, 2018
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: June 28, 2018

Record last verified: 2018-03

Locations

ES (1)