Musculoskeletal ManipulationsNCT04023279
Effects of Myofascial Release and TENS Over Pain, Hand Prehensile Strength and Functionality of Superior Extremity in Women With Lateral Epicondylalgia
A study testing TENS and Myofascial therapy in people with Musculoskeletal Manipulations, run by Fernanda Merino Alvarez at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Musculoskeletal Manipulations
- What is being tested?
- TENS and Myofascial therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- 24 Sep 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Musculoskeletal Manipulations
- Being tested
- TENS, Myofascial therapy
- Keywords
- Manual therapy, Myofascial release, Lateral epicondylitis, Transcutaneous electrical nerve stimulation, Pain, Strength, Functionality
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSOther
Also called Transcutaneous electrical nerve stimulation
100 Hz and 100 usec for 20 minutes
Myofascial therapyOther
Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Conventional TENS of 100 Hz and 100 usec for 20 minutes Receives: 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 Receives: Other: TENS; Other: Myofascial therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start24 Sep 2018
- Primary completion22 Oct 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ManipulationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quantitative, experimental prospective, explanatory type, randomized controlled parallel with simple blind.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda Merino Alvarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernanda Merino Alvarez, Universidad Nacional Andres Bello
- Investigators
- Jorge Fuentes, PhD, Study director, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023279
- Sponsor's protocol ID
- UniversidadNAB
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04023279
- Acronym / sponsor ID
- UniversidadNAB
- Conditions
- Musculoskeletal Manipulations
- Keywords
- Manual therapy, Myofascial release, Lateral epicondylitis, Transcutaneous electrical nerve stimulation, Pain, Strength, Functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fernanda Merino AlvarezUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Quantitative, experimental prospective, explanatory type, randomized controlled parallel with simple blind.
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Other: TENSConventional TENS of 100 Hz and 100 usec for 20 minutes |
| Myofascial Therapy | Experimental | Other: TENS, Other: Myofascial therapyConventional 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSAlso: Transcutaneous electrical nerve stimulation100 Hz and 100 usec for 20 minutes | Other | Myofascial Therapy, TENS |
| Myofascial therapySeven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy | Other | Myofascial Therapy |
Primary outcome
Change in pain intensity numerical rating scale
Time frame: One month
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.
Pressure pain threshold
Time frame: Immediately after treatment
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).
Prehensile hand strength
Time frame: Immediately after treatment
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Fuentes, PhD study director
Universidad Nacional Andres Bello
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and Myofascial therapy in people with Musculoskeletal Manipulations, run by Fernanda Merino Alvarez at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity numerical rating scale (time frame: One month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.