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NCT Number: NCT03677167

The Effect of Barefoot Walking 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.

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Key information

Conditions

Plantar Fascitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meuhedet Health Care Phisiotherapy Clinic

Jerusalem, 9530807, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Ultrasound wave therapy

Primary outcomes

  1. change in results of sf-36 scale from baseline to 4 weeks of intervention and 8 weeks

    Time frame: 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)

    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.

Secondary outcomes

  1. 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

    Time frame: 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)

    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

  2. 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

    Time frame: 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)

    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

  3. change in results of Three clinical tests to diagnose chronic pain in the heel, from baseline to 4 weeks and 8 weeks

    Time frame: 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)

    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)

  4. 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

    Time frame: 1st intervention, after 4 weeks of intervention

    the duration of walking on the treadmill until reaching level 6 on the short borg scale.

  5. change in the walking speed (Kilometer/hour) on the treadmill until reaching level 6 on the short borg scale,from baseline to 4 weeks

    Time frame: 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

  6. short borg scale

    Time frame: 1st intervention, after 4 weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

Meuhedet. Healthcare Organization

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2018
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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