Plantar FascitisNCT03677167
The Effect of Barefoot Walking Plantar Chronic Heel Pain
A study testing walking on a treadmill in people with Plantar Fascitis, run by Meuhedet. Healthcare Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- walking on a treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Aug 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Plantar Fascitis
- Being tested
- walking on a treadmill
- Keywords
- chronic plantar heel pain, barefoot, treadmill, Plantar Fascitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking on a treadmillOther
Also called Ultrasound wave therapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: walking on a treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1st intervention, after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start29 Aug 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meuhedet. Healthcare Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rael Strous, MD,MHA, Principal investigator, Meuhedet Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677167
- Sponsor's protocol ID
- MeuhedetHCO
- Status last verified
- Dec 2019
- First submitted
- 29 Aug 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of the research in the university's databases and scientific journals
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Barefoot Walking on Pain Level, Functional Status and Pressure Pain Threshold in Patients With Plantar Chronic Heel Pain
- ClinicalTrials.gov ID
- NCT03677167
- Acronym / sponsor ID
- MeuhedetHCO
- Conditions
- Plantar Fascitis
- Keywords
- chronic plantar heel pain, barefoot, treadmill, Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Meuhedet. Healthcare OrganizationUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| walking on a treadmill barefoot group | Experimental | Other: walking on a treadmill26 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 |
| Walking on a treadmill with shoes group | Active comparator | Other: walking on a treadmill26 Patients in this group will walk with shoes on the treadmill |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking on a treadmillAlso: Ultrasound wave therapyPatients 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 | Walking on a treadmill with shoes group, walking on a treadmill barefoot group |
Primary outcome
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.
6 secondary outcomes
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)
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)
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)
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
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
short borg scale
Time frame: 1st intervention, after 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Yes. Publication of the research in the university's databases and scientific journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rael Strous, MD,MHA principal investigator
Meuhedet Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking on a treadmill in people with Plantar Fascitis, run by Meuhedet. Healthcare Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.