Other Lesions of Median NerveNCT02150915
Acute Effects of Acupuncture in the Response of the Median Neurodynamic Test
A study testing Acupuncture therapy (leopard spot needling technique) in people with Other Lesions of Median Nerve, run by Nuno Morais at 1 site in Portugal.
Trial summary
The purpose of this study is to test whether the application of acupuncture alters the mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses of the neurodynamic test of nerve median in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Lesions of Median Nerve
- What is being tested?
- Acupuncture therapy (leopard spot needling technique)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- May 2014to Sep 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years-old
- normal mobility in the joints of the upper quadrant
Who cannot join
- pathology that may impair nerve function (eg, diabetes)
- complaints over the past 3 months in the upper quadrant
- significant deformities in the upper quadrant
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto de Ciências Biomédicas Abel Salazar - Universidade do Porto
Porto, Porto District, 4050-313
About this study
Official title: Acute Effects of Acupuncture in the Response of the Median Neurodynamic Test: a Randomised, Double-blind, Non-inferiority Trial
The purpose of this study is to test whether the application of acupuncture alters the mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses of the neurodynamic test of nerve median in asymptomatic individuals
Read the detailed description
To understand the potential of acupuncture therapy in pain syndromes that involve changes of the mechanics and physiology of the peripheral nervous system
- Conditions
- Other Lesions of Median Nerve
- Being tested
- Acupuncture therapy (leopard spot needling technique)
- Keywords
- Acupoints, Acupuncture therapy, Median nerve, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture therapy (leopard spot needling technique)Other
Comparison of the effects of a new or extraordinary acupoint versus a classical acupoint
| Study group | Role | What they receive |
|---|---|---|
| new acupoint | Experimental | Subjets in this arm receive acupuncture therapy in a new acupoint (leopard spot needling technique) Receives: Other: Acupuncture therapy (leopard spot needling technique) |
| classical acupoint | Active comparator | Subjects in this arm receive acupuncture therapy in a classical acupoint in the pericardial conduit (leopard spot needling technique) Receives: Other: Acupuncture therapy (leopard spot needling technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow extension range of motion
Elbow extension range of motion during the median nerve neurodynamic test is measured by means of a smartphone (iPhone 4; app Compass (native); iOS 7.1.1)
Measured: immediately after the application of acupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Lesions of Median NerveStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuno Morais
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Leiria
- Responsible party
- Sponsor-investigator, Nuno Morais, Universidade do Porto
- Investigators
- Henry J Greten, PhD, Principal investigator, Universidade do Porto - Instituto de Ciências Biomédicas Abel Salazar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150915
- Sponsor's protocol ID
- MNT-ACUP-2014
- Status last verified
- Sep 2014
- First submitted
- 27 May 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morais N, Greten HJ, Santos MJ, Machado JP. Immediate effects of acupuncture on the mechanosensitivity of the median nerve: an exploratory randomised trial. Acupunct Med. 2018 Jun;36(3):132-138. doi: 10.1136/acupmed-2016-011357. Epub 2018 May 2.
PubMed 29720378
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Acupuncture in the Response of the Median Neurodynamic Test: a Randomised, Double-blind, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02150915
- Acronym / sponsor ID
- MNT-ACUP-2014
- Conditions
- Other Lesions of Median Nerve
- Keywords
- Acupoints, Acupuncture therapy, Median nerve, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nuno MoraisUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Leiria
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 May 2014 (estimated)
- 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.
The purpose of this study is to test whether the application of acupuncture alters the mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses of the neurodynamic test of nerve median in asymptomatic individuals
Detailed description
To understand the potential of acupuncture therapy in pain syndromes that involve changes of the mechanics and physiology of the peripheral nervous system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new acupoint | Experimental | Other: Acupuncture therapy (leopard spot needling technique)Subjets in this arm receive acupuncture therapy in a new acupoint (leopard spot needling technique) |
| classical acupoint | Active comparator | Other: Acupuncture therapy (leopard spot needling technique)Subjects in this arm receive acupuncture therapy in a classical acupoint in the pericardial conduit (leopard spot needling technique) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years-old
- normal mobility in the joints of the upper quadrant
Key exclusion criteria (3 listed)
- pathology that may impair nerve function (eg, diabetes)
- complaints over the past 3 months in the upper quadrant
- significant deformities in the upper quadrant
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 |
|---|---|---|
| Acupuncture therapy (leopard spot needling technique)Comparison of the effects of a new or extraordinary acupoint versus a classical acupoint | Other | classical acupoint, new acupoint |
Primary outcome
Elbow extension range of motion
Time frame: immediately after the application of acupuncture
Elbow extension range of motion during the median nerve neurodynamic test is measured by means of a smartphone (iPhone 4; app Compass (native); iOS 7.1.1)
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 25 Sep 2014.
- Derived from this study: PubMed 29720378Morais N, Greten HJ, Santos MJ, Machado JP. Immediate effects of acupuncture on the mechanosensitivity of the median nerve: an exploratory randomised trial. Acupunct Med. 2018 Jun;36(3):132-138. doi: 10.1136/acupmed-2016-011357. Epub 2018 May 2.
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.
Henry J Greten, PhD principal investigator
Universidade do Porto - Instituto de Ciências Biomédicas Abel Salazar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture therapy (leopard spot needling technique) in people with Other Lesions of Median Nerve, run by Nuno Morais at 1 site in Portugal.
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 2 inclusion and 3 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 25 Sep 2014. 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 Portugal. 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?
Elbow extension range of motion (time frame: immediately after the application of acupuncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150915, which also lists 1 linked publication.
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 25 Sep 2014.