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HealthyNCT04222946

Stabilometry and Plantar Pressures Changes After Dry Needling in Flexor Digitoum Brevis.

A study testing Dry needling 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 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?
Dry needling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSpain
Study dates
7 Jan 2020to 1 Mar 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

Official title: Stabilometry and Plantar Pressures Changes After Bilateral Dry Needling in Flexor Digitoum Brevis.A Pretest Posttest Study.

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

Read the detailed description

Fiveteen 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 and static footprint. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.

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. Foot plantar pressure and surface area of two static footprints will be measured during bipedal standing. Static plantar pressure will be evaluated by means of maximum pressure, medium pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).

Being tested
Dry needling
Keywords
Stabilometry, Platform, Dry needling, trigger point

What participants receive

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

  • Dry needlingOther

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

Study groups in NCT04222946
Study groupRoleWhat they receive
Experimental:Experimentalbilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
Receives: Other: Dry needling

What is being measured

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

  1. Static footprint

    Static footprint will measure plantar presures and surface area of rear food, midfoot and fore foot. 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. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open.

    Measured: Through study completion, an average of 1 month

  2. Stabilometry variables eyes open

    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 and Y with open eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

    Measured: Through study completion, an average of 1 month

  3. Stabilometry variables eyes closed

    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 and Y with closed eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

    Measured: Through study completion, an average of 1 month

Secondary outcomes (3)

  1. Static footprint after intervention

    Static footprint will measure plantar presures and surface area of rear food, midfoot and fore foot. 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. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open.

    Measured: Through study completion, an average of 1 month

  2. Stabilometry variables eyes open 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 and Y with open eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

    Measured: Through study completion, an average of 1 month

  3. Stabilometry variables eyes closed 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 and Y with closed eyes, Center of Pressure (COP) area and anteroposterior(a-p) and mediolateral directions: COP speed.

    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 posted10 Jan 2020
  2. Study start7 Jan 2020
  3. Primary completion1 Mar 2020
  4. Study completion1 Mar 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 neddling intervention
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04222946
Sponsor's protocol ID
2706201911419
Status last verified
Mar 2020
First submitted
5 Jan 2020
Last updated
3 Mar 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 Dry needling 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 3 Mar 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?

Static footprint (time frame: Through study completion, an average of 1 month). The study lists 3 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 NCT04222946, 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 3 Mar 2020; AzTrials last refreshed its copy on 2 Nov 2026.

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