- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023279
Effects of Myofascial Release and TENS Over Pain, Hand Prehensile Strength and Functionality of Superior Extremity in Women With Lateral Epicondylalgia
Effects of Myofascial Release of the Brachial Biceps and TENS Over the Elbow Pain, Hand Prehensile Strength and Functionality of Superior Extremity in Women With Symptomatology of Chronic Lateral Epicondylalgia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study determined the additive effect of the myofascial release therapy of brachial biceps on TENS in the variables pain intensity, hand prehensile strength and upper limb functionality of individuals with lateral epicondylalgia, compared to a group that received only TENS. This was done in a sample of 32 individuals, assigned in two groups: group A that received an application of TENS and group B that received an application of TENS plus myofascial release therapy.
Contrary to the hypothesis, the application of myofascial release therapy added to the application of TENS proved to generate a significant change only in the prehensile hand force with respect to the group that received only TENS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Concepción
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Talcahuano, Concepción, Chile, 4260000
- Universidad Andrés Bello
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female between 30 and 50 years old.
- Belong to the administrative staff of the university in question
- Have a symptomatic diagnosis of chronic lateral epicondylitis (> 6 weeks)
Exclusion Criteria:
- Being pregnant
- Have done moderate or intense aerobic or anaerobic sport activities of any kind 72 hours before the registrations
- Have an orthopedic, rheumatologic, neuropsychiatric or associated comorbidities diagnosed.
- Have suffered a fracture or trauma involving the upper extremity 4 months before the intervention.
- Be in medical, pharmacological or kinesthetic treatment during the intervention or 2 weeks before this.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TENS
Conventional TENS of 100 Hz and 100 usec for 20 minutes
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100 Hz and 100 usec for 20 minutes
Other Names:
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Experimental: Myofascial Therapy
Conventional TENS of 100 Hz and 100 usec for 20 minutes plus myofascial release therapy in the brachial biceps; Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding
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100 Hz and 100 usec for 20 minutes
Other Names:
Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity numerical rating scale
Time Frame: One month
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Self-reported measure of pain intensity.
It consists on asking to assess pain intensity by selecting a number on a scale of 11 horizontal points.
It is represented from 0 (without pain) to 10 (the worst possible pain) A score of 1 to 4 indicates mild pain; 5-6, moderate pain; and 7 to 10, severe pain.
|
One month
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Pressure pain threshold
Time Frame: Immediately after treatment
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Is the minimum pressure that induces pain or discomfort.
It was measured with a algometer.
It is expressed in units of pressure as kilograms per square centimeter per second (Kg / cm2 / s).
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Immediately after treatment
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Prehensile hand strength
Time Frame: Immediately after treatment
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It is the ability to compress the hand, related to the functional integrity of the upper extremity as an index of general health.
It was measured with a dynamometer.
It was measured according to the criteria established by the American Society of Hand Therapists.
It is measured in kilograms
|
Immediately after treatment
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Change in Elbow functionality.
Time Frame: One month
|
Functionality is a generic term that includes bodily functions, body structures, activities and participation. It shows the positive aspects of a person's interaction and the context. It was obtained through a scale of functionality (Oxford Elbow Score), which is composed of three domains (subscales); elbow, pain and social-psychological function, which underlie 12 questions, which are internally consistent, one-dimensional and do not have redundancy of items. The scores of each domain are calculated as the sum of the score of each individual element, where each case is expressed on a scale from 0 to 100 where, a score of 0.84 indicates a substantial improvement. |
One month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jorge Fuentes, PhD, Universidad Andrés Bello
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UniversidadNAB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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