NCT04023279

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

28 days

First QC Date

July 7, 2019

Last Update Submit

July 16, 2019

Conditions

Keywords

Manual therapyMyofascial releaseLateral epicondylitisTranscutaneous electrical nerve stimulationPainStrengthFunctionality

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

EXPERIMENTAL

Conventional TENS of 100 Hz and 100 usec for 20 minutes

Other: TENS

Myofascial Therapy

EXPERIMENTAL

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

Other: TENSOther: Myofascial therapy

Interventions

TENSOTHER

100 Hz and 100 usec for 20 minutes

Also known as: Transcutaneous electrical nerve stimulation
Myofascial TherapyTENS

Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy

Myofascial Therapy

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Tennis ElbowPain

Interventions

Transcutaneous Electric Nerve StimulationMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Officials

  • Jorge Fuentes, PhD

    Universidad Andres Bello

    STUDY DIRECTOR

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
Model Details: Quantitative, experimental prospective, explanatory type, randomized controlled parallel with simple blind.
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

Locations