The Effect of Barefoot Walking Plantar Chronic Heel Pain

NCT03677167 | Completed

• 1 other identifier: MeuhedetHCO
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fascitis

Keywords

chronic plantar heel pain; barefoot; treadmill; Plantar Fascitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  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

  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

  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

  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

  1st intervention, after 4 weeks of intervention

Study Arms (2)

walking on a treadmill barefoot group

EXPERIMENTAL

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

Walking on a treadmill with shoes group

ACTIVE COMPARATOR

26 Patients in this group will walk with shoes on the treadmill

Other: walking on a treadmill

Interventions

walking on a treadmill OTHER

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

Also known as: Ultrasound wave therapy

Walking on a treadmill with shoes group; walking on a treadmill barefoot group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meuhedet. Healthcare Organization: lead

Study Sites (1)

Meuhedet Health Care Phisiotherapy Clinic

Jerusalem, 9530807, Israel

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rael Strous, MD,MHA

  Meuhedet Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physiotherapist who examines patients before and after the intervention does not know which group the patient belongs to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will include 52 subjects with heel pain for more than 12 weeks. The subjects will be randomly assigned to one of two groups: a barefoot walking group on a treadmill and a walking group in shoes on a treadmill. The subjects will receive treatment twice a week at the Meuhedet Health Fund Institute for 4 weeks. All subjects will be instructed to walk on the treadmill until they reach level 6 on the Short Borg Scale. In addition, all subjects will receive an ultrasound treatment for 5 minutes each session. Before and after the intervention, the subjects will complete the SF-36 questionnaire, and will assess the level of pain they experience on the heel during initial treading down from the bed in the morning. In addition, the minimum pain threshold and pain tolerance will be checked with an algometer at relevant points in the heel and the speed and walking time will be documented.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 19, 2018
• Study Start: August 29, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2021
• 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

Locations

IL (1)