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HealthyNCT04599322

Stabilometry Changes After Dry Needling in Flexor Digitoum Brevis

A study testing Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle in people with Healthy and Foot, run by Mayuben Private Clinic at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this clinical trial is to check the balance effects of dry needling in the Flexor digitorum Brevis Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Healthy, Foot, Dry Needling
What is being tested?
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSpain
Study dates
9 Nov 2020to 16 Nov 2020
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 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Healthy individuals
  • Must have latent trigger point in Flexor Brevis Digitorum muscles

Who cannot join

  • Previous lower extremities surgery.
  • History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
  • Leg-length discrepancy more than 1 cm
  • Balance deficits (determined by oral questionnaire regarding falls)

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Mayuben Clinic

    San Sebastián de los Reyes, Madrid, 28702

Other trials in Spain

About this study

The aim of this clinical trial is to check the balance effects of dry needling in the Flexor digitorum Brevis

Read the detailed description

Eighteen healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure stabilometry variables with eyes open and closed.

Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed.

Being tested
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Keywords
Stabilometry, Dry needling, Trigger point

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis MuscleOther

    Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle

Study groups in NCT04599322
Study groupRoleWhat they receive
Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger pointExperimentalBilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
Receives: Other: Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stabilometry variable x displacement open eyes before dry needling

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in milimeters) with open eyes.

    Measured: Through study completion, an average of 1 week

  2. Stabilometry variable y displacement open eyes before dry needling

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in milimeters) with open eyes.

    Measured: Through study completion, an average of 1 week

  3. Stabilometry variable center of pressure area open eyes before dry needling

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of Pressure (COP) area (in milimeters²) with eyes open.

    Measured: Through study completion, an average of 1 month

  4. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before dry needling

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

  5. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before dry needling

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

  6. Stabilometry variable x displacement before dry needling with closed eyes

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in milimeters) with eyes closed.

    Measured: Through study completion, an average of 1 month

  7. Stabilometry variable y displacement before dry needling with closed eyes

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in milimeters) with closed eyes.

    Measured: Through study completion, an average of 1 month

  8. Stabilometry variable center of pressure area before dry needling with closed eyes

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of Pressure (COP) area (in milimeters²) with eyes closed.

    Measured: Through study completion, an average of 1 month

  9. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction before dry needling with closed eyes

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

  10. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction before dry needling with closed eyes

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

Secondary outcomes (10)
  1. Stabilometry variable x displacement open eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in milimeters) with open eyes.

    Measured: Through study completion, an average of 1 month

  2. Stabilometry variable y displacement open eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in milimeters) with open eyes.

    Measured: Through study completion, an average of 1 month

  3. Stabilometry variable center of pressure area open eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of Pressure (COP) area (in milimeters²) with eyes open.

    Measured: Through study completion, an average of 1 month

  4. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with open eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

  5. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with open eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

  6. Stabilometry variable x displacement with closed eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in milimeters) with eyes closed.

    Measured: Through study completion, an average of 1 month

  7. Stabilometry variable y displacement with closed eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in milimeters) with closed eyes.

    Measured: Through study completion, an average of 1 month

  8. Stabilometry variable center of pressure area with closed eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of Pressure (COP) area (in milimeters²) with eyes closed.

    Measured: Through study completion, an average of 1 month

  9. Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with closed eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

  10. Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with closed eyes after intervention

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Measured: Through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start9 Nov 2020
  3. Primary completion9 Nov 2020
  4. Study completion16 Nov 2020

Resources

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
Not applicable
Intervention model
Single group
Model description
Pretest posttest of bilateral Flexor digitorum Brevis dry needling intervention
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04599322
Sponsor's protocol ID
2706201911419 B
Status last verified
Nov 2020
First submitted
3 Oct 2020
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salvioli S, Guidi M, Marcotulli G. The effectiveness of conservative, non-pharmacological treatment, of plantar heel pain: A systematic review with meta-analysis. Foot (Edinb). 2017 Dec;33:57-67. doi: 10.1016/j.foot.2017.05.004. Epub 2017 Jun 15.

    PubMed 29126045
  • David JA, Sankarapandian V, Christopher PR, Chatterjee A, Macaden AS. Injected corticosteroids for treating plantar heel pain in adults. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009348. doi: 10.1002/14651858.CD009348.pub2.

    PubMed 28602048
  • Salom-Moreno J, Sanchez-Mila Z, Ortega-Santiago R, Palacios-Cena M, Truyol-Dominguez S, Fernandez-de-las-Penas C. Changes in spasticity, widespread pressure pain sensitivity, and baropodometry after the application of dry needling in patients who have had a stroke: a randomized controlled trial. J Manipulative Physiol Ther. 2014 Oct;37(8):569-79. doi: 10.1016/j.jmpt.2014.06.003. Epub 2014 Sep 8.

    PubMed 25199825
  • Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized controlled trial. Phys Ther. 2014 Aug;94(8):1083-94. doi: 10.2522/ptj.20130255. Epub 2014 Apr 3.

    PubMed 24700136
  • McNally EG, Shetty S. Plantar fascia: imaging diagnosis and guided treatment. Semin Musculoskelet Radiol. 2010 Sep;14(3):334-43. doi: 10.1055/s-0030-1254522. Epub 2010 Jun 10.

    PubMed 20539958

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle in people with Healthy and Foot, run by Mayuben Private Clinic at 1 site in Spain.

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 4 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 18 Nov 2020. 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 Spain. 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?

Stabilometry variable x displacement open eyes before dry needling (time frame: Through study completion, an average of 1 week). The study lists 10 primary outcomes in all. 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 NCT04599322, which also lists 5 linked publications.

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 18 Nov 2020.

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