- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04222946
Stabilometry and Plantar Pressures Changes After Dry Needling in Flexor Digitoum Brevis.
Stabilometry and Plantar Pressures Changes After Bilateral Dry Needling in Flexor Digitoum Brevis.A Pretest Posttest Study.
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
San Sebastián De Los Reyes, Madrid, Spain, 28702
- Mayuben Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental:
bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point
|
Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static footprint
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
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
Time Frame: Through study completion, an average of 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static footprint after intervention
Time Frame: Through study completion, an average of 1 month
|
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 after intervention
Time Frame: Through study completion, an average of 1 month
|
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 after intervention
Time Frame: Through study completion, an average of 1 month
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva María Martínez-Jimenez, Mayuben Clinic
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2706201911419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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