Effects of Myofascial Release and TENS Over Pain, Hand Prehensile Strength and Functionality of Superior Extremity in Women With Lateral Epicondylalgia
1 other identifier
interventional
32
1 country
1
Brief Summary
This study evaluated the additive effect of myofascial release therapy on the brachial biceps on conventional management (TENS) in pain intensity, hand prehensile strength and upper limb functionality of individuals with lateral epicondylalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedFirst Submitted
Initial submission to the registry
July 7, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedJuly 17, 2019
July 1, 2019
28 days
July 7, 2019
July 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in pain intensity numerical rating scale
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
Pressure pain threshold
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).
Immediately after treatment
Prehensile hand strength
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
Change in Elbow functionality.
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
Study Arms (2)
TENS
EXPERIMENTALConventional TENS of 100 Hz and 100 usec for 20 minutes
Myofascial Therapy
EXPERIMENTALConventional 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
Interventions
100 Hz and 100 usec for 20 minutes
Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Andres Bello
Talcahuano, Concepción, 4260000, Chile
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jorge Fuentes, PhD
Universidad Andres Bello
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- The hidden assignment of the participants was carried out using the method of opaque envelopes sealed and numbered consecutively. The assessor in charge of evaluating the participants was blind to the treatment assignment, where he proceeded to take the measurements with a prior instruction of the procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor and Principal Investigator Fernanda Merino Alvarez
Study Record Dates
First Submitted
July 7, 2019
First Posted
July 17, 2019
Study Start
September 24, 2018
Primary Completion
October 22, 2018
Study Completion
December 20, 2018
Last Updated
July 17, 2019
Record last verified: 2019-07