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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04599322
Other study ID # 2706201911419 B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date November 16, 2020

Study information

Verified date November 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 balance effects of dry needling in the Flexor digitorum Brevis


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date November 16, 2020
Est. primary completion date November 9, 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:
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
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 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary 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). Through study completion, an average of 1 month
Secondary 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). Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary 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). Through study completion, an average of 1 month
Secondary 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). Through study completion, an average of 1 month
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