NCT04599322

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

Same day

First QC Date

October 3, 2020

Last Update Submit

November 16, 2020

Conditions

Keywords

StabilometryDry needlingTrigger point

Outcome Measures

Primary Outcomes (10)

  • 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.

    Through study completion, an average of 1 week

  • 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.

    Through study completion, an average of 1 week

  • 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.

    Through study completion, an average of 1 month

  • 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).

    Through study completion, an average of 1 month

  • 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).

    Through study completion, an average of 1 month

  • 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.

    Through study completion, an average of 1 month

  • 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.

    Through study completion, an average of 1 month

  • 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.

    Through study completion, an average of 1 month

  • 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).

    Through study completion, an average of 1 month

  • 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).

    Through study completion, an average of 1 month

Secondary Outcomes (10)

  • Stabilometry variable x displacement open eyes after intervention

    Through study completion, an average of 1 month

  • Stabilometry variable y displacement open eyes after intervention

    Through study completion, an average of 1 month

  • Stabilometry variable center of pressure area open eyes after intervention

    Through study completion, an average of 1 month

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

    Through study completion, an average of 1 month

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

    Through study completion, an average of 1 month

  • +5 more secondary outcomes

Study Arms (1)

Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point

EXPERIMENTAL

Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point

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

Interventions

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

Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Related Publications (5)

  • 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.

    PMID: 29126045BACKGROUND
  • 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.

    PMID: 28602048BACKGROUND
  • 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.

    PMID: 25199825BACKGROUND
  • 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.

    PMID: 24700136BACKGROUND
  • 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.

    PMID: 20539958BACKGROUND

Study Officials

  • Eva María Martínez-Jimenez

    Mayuben Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pretest posttest of bilateral Flexor digitorum Brevis dry needling intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist

Study Record Dates

First Submitted

October 3, 2020

First Posted

October 22, 2020

Study Start

November 9, 2020

Primary Completion

November 9, 2020

Study Completion

November 16, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations