The Effect of Barefoot Walking Plantar Chronic Heel Pain

The Effect of Barefoot Walking on Pain Level, Functional Status and Pressure Pain Threshold in Patients With Plantar Chronic Heel Pain

Many patients suffer from chronic heel pain, and studies have not yet found the most appropriate treatment. There are some researchers who claim that the pain is caused by weakness in the muscles of the foot, which causes increased pressure in the heel. In walking, the muscles of the foot are activated and strengthened. No research has yet been done on whether walking (barefoot or with shoes) on a treadmill reduces pain in the heel and improves function.

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis
• Intervention / Treatment: Other: walking on a treadmill

Detailed Description

A bare foot functions differently than a foot in a shoe while walking, as there are differences in movement, muscle tone, pressure and sensation. Wearing shoes over the years can cause changes in walking and pain. In the examination of the feet of patients suffering from chronic pain in the heel was found a smaller volume of muscle, and calcification in the heel area that could be caused by increased pressure. Although the trend of physiotherapy treatments has changed in recent years from passive to active treatments, the overwhelming majority of studies are testing passive therapies only as a treatment option for chronic heel pain. Barefoot walking has not been tested as an option for treating chronic pain in the heel, although there are studies indicating that bare feet lead to reduced heel pressure, increased muscle work, and better proprioception.The purpose of this study is to examine the effect of barefoot walking on the level of pain, function and pain threshold for stress in patients with chronic heel pain.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9530807
    • Meuhedet Health Care Phisiotherapy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Local pain in the heel that lasts more than 12 weeks,
• pain in the first steps in the morning
• Pain that disappears in situations of weightlessness
• Ability to walk on a moving track.

Exclusion Criteria:

• Pain in proximal areas along the leg or lower back pain that can radiate to the heel
• Sensory disorders for various reasons
• Tumors, fractures, previous operations in the lower extremities
• Irritable cardiovascular problems
• Balance problems and dizziness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: walking on a treadmill barefoot group; 26 Patients in this group will walk barefoot on the treadmill and will be asked to walk barefoot at home and report the time of barefoot walking at home	Other: walking on a treadmill; Patients will go on the treadmill (barefoot or with shoes) twice a week for a month, up to a medium-high level effort, and will receive ultrasound treatment for the painful heel spot; Other Names: Ultrasound wave therapy
Active Comparator: Walking on a treadmill with shoes group; 26 Patients in this group will walk with shoes on the treadmill	Other: walking on a treadmill; Patients will go on the treadmill (barefoot or with shoes) twice a week for a month, up to a medium-high level effort, and will receive ultrasound treatment for the painful heel spot; Other Names: Ultrasound wave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in results of sf-36 scale from baseline to 4 weeks of intervention and 8 weeks	This is a questionnaire consisting of eight separate parts, each section examining a different aspect of quality of life. In the evaluation of pain in the heel, it is customary to use a part that assesses functional function, and in part that evaluates physical pain. The score ranges from 0 - very low, to 100 - very high. A change of 7.8 points indicates a change in the level of pain and physical function.	before intervention, after 4 weeks of intervention, after 4 weeks from the end of intervention (i.e. baseline to 4 weeks of intervention and 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in results of VAS pain in the heel that appears on the first step in the morning from baseline to 4 weeks and 8 weeks	The ladder is 10 cm long, and the patient must surround the number that corresponds to his or her pain intensity, 0 - does not hurt at all, and 10 - the most severe and intolerable pain. When a change of 1.4 cm out of 10 cm indicates a change in the patient's pain level	before intervention, after 4 weeks of intervention, after 4 weeks from the end of intervention (i.e. baseline to 4 weeks of intervention and 8 weeks)
change in results of Pain threshold severity for minimum pressure and tolerance threshold for pain for pressure at five points in the heel, from baseline to 4 weeks and 8 weeks	The algometer will measure the intensity of the pressure at the point of pain until reaching the minimum pain (P1) and also until reaching the threshold of pain tolerance	before intervention, after 4 weeks of intervention, after 4 weeks from the end of intervention (i.e. baseline to 4 weeks of intervention and 8 weeks)
change in results of Three clinical tests to diagnose chronic pain in the heel, from baseline to 4 weeks and 8 weeks	Three clinical trials have been found to be relevant to the diagnosis of chronic heel pain. All the tests listed below are performed on the painful leg and until the first sensation of pain (p1) is produced: Static standing on one leg: measuring the number of seconds (up to 20 sec) and the level of pain on a visual analog scale (VAS);; Crouching on one leg: measuring the number of repetitions (up to10 rep) and the level of pain according to VAS;; Ascension on fingertips: Measuring the number of repetitions (up to10 rep) and the level of pain according to VAS. It was found that when pain is produced in one of the above tests, the patient may be diagnosed with chronic heel pain. The results options for all of the above tests are "positive" (if at least one of the tests creates pain) or "negative" (if non of the tests creates pain)	before intervention, after 4 weeks of intervention, after 4 weeks from the end of intervention (i.e. baseline to 4 weeks of intervention and 8 weeks)
change in the duration (minuets) of walking on the treadmill until reaching level 6 on the short borg scale,from base line to 4 weeks	the duration of walking on the treadmill until reaching level 6 on the short borg scale.	1st intervention, after 4 weeks of intervention
change in the walking speed (Kilometer/hour) on the treadmill until reaching level 6 on the short borg scale,from baseline to 4 weeks	change in the walking speed (Kilometer/hour) on the treadmill until reaching level 6 on the short borg scale	1st intervention, after 4 weeks of intervention
short borg scale	The short borg scale is a scale that assesses the intensity of physical activity according to the subjective feeling of the patient. The short borg scale ranges from 0 - rest mode to 10 - maximum exertion. Training at level 5-6 has been found to be effective in achieving physiological improvement.	1st intervention, after 4 weeks of intervention

Collaborators and Investigators

• Sponsor: Meuhedet. Healthcare Organization
• Investigators: Principal Investigator: Rael Strous, MD,MHA, Meuhedet Health Care

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: treadmill; Plantar Fascitis; chronic plantar heel pain; barefoot
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: MeuhedetHCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication of the research in the university's databases and scientific journals
• IPD Sharing Time Frame: January 2021
• IPD Sharing Access Criteria: After the thesis is completed, the research details will be available in the databases of Tel Aviv University, and after it is written as an article, it will be available in a journal that will publish the research
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No