Back to resultsComparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
Primary Purpose
Tendinopathy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group of Dry Needling
Group of Electrolysis
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring ntratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Lateral epicondyle
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.
Sites / Locations
- Opel EspañaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Group of Dry Needling
Group of electrolysis
Control Group
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Thickness of the tendon, as measured by ultrasound scan
Tendon structure
Hypervascularity, as measured by ultrasound scan
Tendon structure
Full Information
NCT ID
NCT03572803
First Posted
June 14, 2018
Last Updated
June 27, 2018
Sponsor
Universidad San Jorge
Collaborators
University of Seville
1. Study Identification
Unique Protocol Identification Number
NCT03572803
Brief Title
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
Official Title
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
ntratissue Percutaneous Electrolysis, Dry needling, Eccentric exercise, Lateral epicondyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of Dry Needling
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group of electrolysis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Group of Dry Needling
Intervention Description
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
Intervention Name(s)
Group of Electrolysis
Intervention Description
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
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in quality of life by DASH
Description
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.
Time Frame
Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Secondary Outcome Measure Information:
Title
Pain, as measured by Visual Analog Scale
Description
Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain.
Time Frame
Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Title
Pressure pain thresholds (PPTs)
Description
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.
Time Frame
Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Title
Pain free grip strength
Description
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.
Time Frame
Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)
Title
Thickness of the tendon, as measured by ultrasound scan
Description
Tendon structure
Time Frame
Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
Title
Hypervascularity, as measured by ultrasound scan
Description
Tendon structure
Time Frame
Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Mª Galán Díaz, MD
Phone
+34660222284
Email
rmgalan@usj.es
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Herrero Gallego, PhD
Phone
+976060100
Email
pherrero@usj.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Mª Galán Díaz, MD
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Herrero Gallego, PhD
Organizational Affiliation
Universidad San Jorge
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cleofas Rodríguez Blanco, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Opel España
City
Figueruelas
State/Province
Zaragoza
ZIP/Postal Code
50639
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Mª Galán Díaz, MD
Phone
+34660222284
Email
rmgalan@usj.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
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