NCT04201795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

December 9, 2019

Last Update Submit

January 29, 2020

Conditions

Keywords

fasciamyofascialplantar fasciapostural balancestabilometryplatform

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • static footprint after intervention

    Through study completion, an average of 1 month

  • stabilometry variables eyes open after intervention

    Through study completion, an average of 1 month

  • stabilometry variables eyes after intervention

    Through study completion, an average of 1 month

Study Arms (2)

pressure and traction

EXPERIMENTAL

pressure and traction durin 5 minutes will be applied in plantar fascia

Other: pressure and traction tecnique

Laser

SHAM COMPARATOR

Applied during 5 minutes each plantar fascia of sham laser

Other: Laser

Interventions

LaserOTHER

laser with no emision will applied

Laser

pressure and traction in plantar fascia with hands will be applied

pressure and traction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Must have no pain

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Related 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.

    PMID: 24703512BACKGROUND
  • 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.

    PMID: 22236639BACKGROUND
  • 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.

    PMID: 25892389BACKGROUND
  • 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.

    PMID: 16776486BACKGROUND
  • 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.

    PMID: 28715296BACKGROUND

MeSH Terms

Interventions

LasersPressure

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesMechanical PhenomenaPhysical Phenomena

Study Officials

  • Eva María Martínez-Jimenez

    Mayuben Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blind masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two arms parallel ( intervention and control) will be randomized asigned to compare pressure and traction tecnique versus laser placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 17, 2019

Study Start

November 29, 2019

Primary Completion

December 30, 2019

Study Completion

January 29, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations