Clinical trial NCT03677167: The Effect of Barefoot Walking Plantar Chronic Heel Pain
Official title: The Effect of Barefoot Walking on Pain Level, Functional Status and Pressure Pain Threshold in Patients With Plantar Chronic Heel Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: chronic plantar heel pain
barefoot
treadmill
Plantar Fascitis
Lead sponsor: Meuhedet. Healthcare Organization
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in results of sf-36 scale from baseline to 4 weeks of intervention and 8 weeks
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: change in results of Three clinical tests to diagnose chronic pain in the heel, from baseline to 4 weeks and 8 weeks
timeFrame: 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)
measure: 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
timeFrame: 1st intervention, after 4 weeks of intervention
measure: change in the walking speed (Kilometer/hour) on the treadmill until reaching level 6 on the short borg scale,from baseline to 4 weeks
timeFrame: 1st intervention, after 4 weeks of intervention
measure: short borg scale
timeFrame: 1st intervention, after 4 weeks of intervention
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Meuhedet Health Care Phisiotherapy Clinic
Study officials:
affiliation: Meuhedet Health Care
name: Rael Strous, MD,MHA
role: PRINCIPAL_INVESTIGATOR
References: