Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance

Healthy Clinical Trial

Official title:

Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance Against a Placebo Laser: A Randomized Single Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201795
• Other study ID #: 2111201814518
• Status: Completed
• Phase: N/A
• Start date: November 29, 2019
• Est. completion date: January 29, 2020

Study information

• Verified date: January 2020
• Source: Mayuben Private Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to check the effects of manual pressure and traction technique on balance and plantar footprint variables comparing with Laser placebo.

Description:

Forty healthy subjects wil be recruited for a simple blind study. Participants will be from 1 to 40 years old, not obese. Participants will be randomized into two groups. Experimental group performed a bilateral plantar fascia manual pressure and traction technique. Control group performed a laser placebo. The time duration (5 minutes), position, and therapist were the same for both treatments. 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: 40
• Est. completion date: January 29, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy individuals

• Must have no pain

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)

Related Conditions & MeSH terms

• Foot
• Healthy
• Manual Therapy

Intervention

Other:
• Laser
laser with no emision will applied
• pressure and traction tecnique
pressure and traction in plantar fascia with hands will be applied

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)

Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21. — View Citation

Ajimsha MS, Chithra S, Thulasyammal RP. Effectiveness of myofascial release in the management of lateral epicondylitis in computer professionals. Arch Phys Med Rehabil. 2012 Apr;93(4):604-9. doi: 10.1016/j.apmr.2011.10.012. Epub 2012 Jan 10. — View Citation

Hyland MR, Webber-Gaffney A, Cohen L, Lichtman PT. Randomized controlled trial of calcaneal taping, sham taping, and plantar fascia stretching for the short-term management of plantar heel pain. J Orthop Sports Phys Ther. 2006 Jun;36(6):364-71. — View Citation

Ichikawa K, Takei H, Usa H, Mitomo S, Ogawa D. Comparative analysis of ultrasound changes in the vastus lateralis muscle following myofascial release and thermotherapy: a pilot study. J Bodyw Mov Ther. 2015 Apr;19(2):327-36. doi: 10.1016/j.jbmt.2014.11.018. Epub 2014 Dec 23. — View Citation

Lee M, Kim M, Oh S, Choi YJ, Lee D, Lee SH, Yoon B. A self-determination theory-based self-myofascial release program in older adults with myofascial trigger points in the neck and back: A pilot study. Physiother Theory Pract. 2017 Sep;33(9):681-694. doi: 10.1080/09593985.2017.1345024. Epub 2017 Jul 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	static footprint	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	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 (27), 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 closed	Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), 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 closed	Through study completion, an average of 1 month
Secondary	static footprint 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	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 (27), 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 after intervention	Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), 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 closed	Through study completion, an average of 1 month