NCT04222946

Brief Summary

The aim of this clinical trial is to check the 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 Jan 2020

Shorter than P25 for not_applicable healthy

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

January 5, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

January 5, 2020

Last Update Submit

March 1, 2020

Conditions

Keywords

StabilometryPlatformDry needlingtrigger point

Outcome Measures

Primary Outcomes (3)

  • 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.

    Through study completion, an average of 1 month

  • 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.

    Through study completion, an average of 1 month

  • 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.

    Through study completion, an average of 1 month

Secondary Outcomes (3)

  • Static footprint after intervention

    Through study completion, an average of 1 month

  • Stabilometry variables eyes open after intervention

    Through study completion, an average of 1 month

  • Stabilometry variables eyes closed after intervention

    Through study completion, an average of 1 month

Study Arms (1)

Experimental:

EXPERIMENTAL

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

Other: Dry needling

Interventions

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

Experimental:

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

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

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 neddling intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 10, 2020

Study Start

January 7, 2020

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations