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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04222946
Other study ID # 2706201911419
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2020
Est. completion date March 1, 2020

Study information

Verified date March 2020
Source Mayuben Private Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy individuals

- Must have latent trigger point in Flexor Brevis Digitorum muscles

Exclusion Criteria:

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Mayuben Clinic San Sebastián De Los Reyes Madrid

Sponsors (1)

Lead Sponsor Collaborator
Mayuben Private Clinic

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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:CD009348. doi: 10.1002/14651858.CD009348.pub2. Review. — View Citation

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. Review. — View Citation

Salom-Moreno J, Sánchez-Mila Z, Ortega-Santiago R, Palacios-Ceña M, Truyol-Domínguez S, Fernández-de-las-Peñas 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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
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