Clinical trial NCT04201795: Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance
Official title: Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance Against a Placebo Laser: A Randomized Single Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Foot
Manual Therapy
Keywords: fascia
myofascial
plantar fascia
postural balance
stabilometry
platform
Lead sponsor: Mayuben Private Clinic
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms parallel ( intervention and control) will be randomized asigned to compare pressure and traction tecnique versus laser placebo
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: static footprint
timeFrame: Through study completion, an average of 1 month
measure: stabilometry variables eyes open
timeFrame: Through study completion, an average of 1 month
measure: stabilometry variables eyes closed
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: static footprint after intervention
timeFrame: Through study completion, an average of 1 month
measure: stabilometry variables eyes open after intervention
timeFrame: Through study completion, an average of 1 month
measure: stabilometry variables eyes after intervention
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: San Sebastián De Los Reyes
country: Spain
facility: Mayuben Clinic
state: Madrid
Study officials:
affiliation: Mayuben Clinic
name: Eva María Martínez-Jimenez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. doi: 10.2519/jospt.2006.2078.
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.