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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02343809 |
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Date of registration:
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16/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diacutaneous Fibrolysis on Lateral Epicondylitis
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Scientific title:
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Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02343809 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Carlos López, M.Sc |
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Address:
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Telephone:
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934711912 |
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Email:
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carlesldc@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years old and over
- Diagnosis of chronic lateral epicondylalgia
- Sign the informed consent form
Exclusion Criteria:
- Concomitant conditions affecting the same upper extremity
- Contraindications for Diacutaneous Fibrolysis
- Corticosteroid injections or similar agents in the three months prior to study
inclusion
- Pending litigation or legal claim
- Poor language and communication skills making difficult to understand the informed
consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tennis Elbow
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Intervention(s)
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Other: Actual Diacutaneous Fibrolysis
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Other: Protocolized Physiotherapy
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Other: Sham Diacutaneous Fibrolysis
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Primary Outcome(s)
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Pain intensity
[Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months]
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Secondary Outcome(s)
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Global Rating of Change scale
[Time Frame: post-intervention, after three months]
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Functional status
[Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months]
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Pressure Pain Threshold
[Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months]
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Pain free grip strength
[Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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