Plantar FasciitisNCT02679326
Plantar Fasciitis and Therapeutic Ultrasound
A study testing Therapeutic ultrasound in people with Plantar Fasciitis, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Therapeutic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to 28 May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Worsening symptoms first steps in the morning or at the beginning of walking after sitting for long periods, and after long walking or standing.
- Pain at the bottom of the heel produced by weight bearing or local press.
- Pain level 3 or higher on NPRS at first steps in the morning.
- Tenderness, swelling, or both in the region of proximal plantar fascia and at medial plantar tuberosity of the calcaneous.
- Gradual development of pain at the bottom of the heel.
Who cannot join
- Peripheral neuropathy.
- Tarsal tunnel syndrome (TTS) \ Fat Pad Syndrome (FPS).
- Calcaneal cyst, Fracture or bone cancer.
- Osteo Arthritis (OA) of the foot fingers or Rheumatoid arthritis (RA).
- Foot surgery at the last year.
- Steroid injections at the last six months.
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- Pregnancy.
- Foot infection or diabetic foot.
- Stress fractures of the heel.
- Unavailability in advance to participate in research.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Maccabee Health Services Physical therapy Clinic
Rehovot, Southern District
About this study
Official title: The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound
The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).
Read the detailed description
Plantar fasciitis (PF) is the main cause of pain in the bottom of the heel. According to the American Physical Therapy Association guidelines since 2008, many treatments have been described to correct the problem, but there are very few high level randomized trials that proved them. Although not mentioned even in clinical treatment guidelines in PF, one of the most common conservative treatments for use, in general and Israel in particular, is a therapeutic ultrasound device. Despite this widespread use, there are very few research evidence which examining the effectiveness of this device for the treatment of PF. The purpose of this study is to evaluate the effect of therapeutic ultrasound versus sham ultrasound on pain, function and quality of life of patients with PF. Our hypothesis is that the use of ultrasound parameters that cause an increase in the target tissue heat (from 1.75 to 1 W/cm2, Continues intensity of 1 MHZ) will result in a significant improvement than placebo. To evaluate this hypothesis, we will do a prospective, controlled, randomized, double-blind interventional clinical study. The study population will include 60 patients, aged 18 or older, suffering from PF and meet inclusion criteria. Subjects will be divided randomly into study or control group, Both groups will receive stretching Instructions, when the study group will Receive active ultrasound and the control group will Receive sham ultrasound. Both groups will receive 8 treatments, twice a week.
- Conditions
- Plantar Fasciitis
- Being tested
- Therapeutic ultrasound
- Keywords
- Therapeutic ultrasound, Treatment, Plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | will receive stretching guidance and high level active Ultrasound Receives: Device: Therapeutic ultrasound |
| control group | Placebo comparator | will receive stretching guidance and very low level of Ultrasound Receives: Device: Therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS) at morning
pain level at the heel at the first step in the morning.
Measured: at morning after 4 weeks of treatment
Secondary outcomes (3)
NPRS during the day
pain level during the day.
Measured: 1 day
Foot & Ankle computerized adaptive test (CAT)
Questionnaire of quality of life
Measured: 2 & 4 weeks of treatment
Algometric test
Average of 3 testing of Pressure on the medial tuberosity
Measured: 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startMay 2015
- Primary completion28 May 2017
- Study completion28 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies 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
- Single group
- Model description
- Double blinded RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Ben-izhak, PHD, Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679326
- Sponsor's protocol ID
- 4/2015
- Status last verified
- Jan 2017
- First submitted
- 7 Feb 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound
- ClinicalTrials.gov ID
- NCT02679326
- Acronym / sponsor ID
- 4/2015
- Conditions
- Plantar Fasciitis
- Keywords
- Therapeutic ultrasound, Treatment, Plantar fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 28 May 2017 (actual)
- Study completion
- 28 May 2017 (actual)
- First posted
- 10 Feb 2016 (estimated)
- 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.
The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).
Detailed description
Plantar fasciitis (PF) is the main cause of pain in the bottom of the heel. According to the American Physical Therapy Association guidelines since 2008, many treatments have been described to correct the problem, but there are very few high level randomized trials that proved them. Although not mentioned even in clinical treatment guidelines in PF, one of the most common conservative treatments for use, in general and Israel in particular, is a therapeutic ultrasound device. Despite this widespread use, there are very few research evidence which examining the effectiveness of this device for the treatment of PF. The purpose of this study is to evaluate the effect of therapeutic ultrasound versus sham ultrasound on pain, function and quality of life of patients with PF. Our hypothesis is that the use of ultrasound parameters that cause an increase in the target tissue heat (from 1.75 to 1 W/cm2, Continues intensity of 1 MHZ) will result in a significant improvement than placebo. To evaluate this hypothesis, we will do a prospective, controlled, randomized, double-blind interventional clinical study. The study population will include 60 patients, aged 18 or older, suffering from PF and meet inclusion criteria. Subjects will be divided randomly into study or control group, Both groups will receive stretching Instructions, when the study group will Receive active ultrasound and the control group will Receive sham ultrasound. Both groups will receive 8 treatments, twice a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded RCT
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Therapeutic ultrasoundwill receive stretching guidance and high level active Ultrasound |
| control group | Placebo comparator | Device: Therapeutic ultrasoundwill receive stretching guidance and very low level of Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Worsening symptoms first steps in the morning or at the beginning of walking after sitting for long periods, and after long walking or standing.
- Pain at the bottom of the heel produced by weight bearing or local press.
- Pain level 3 or higher on NPRS at first steps in the morning.
- Tenderness, swelling, or both in the region of proximal plantar fascia and at medial plantar tuberosity of the calcaneous.
- Gradual development of pain at the bottom of the heel.
Key exclusion criteria (10 listed)
- Peripheral neuropathy.
- Tarsal tunnel syndrome (TTS) \ Fat Pad Syndrome (FPS).
- Calcaneal cyst, Fracture or bone cancer.
- Osteo Arthritis (OA) of the foot fingers or Rheumatoid arthritis (RA).
- Foot surgery at the last year.
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 |
|---|---|---|
| Therapeutic ultrasound | Device | control group, study group |
Primary outcome
Numerical Pain Rating Scale (NPRS) at morning
Time frame: at morning after 4 weeks of treatment
pain level at the heel at the first step in the morning.
3 secondary outcomes
NPRS during the day
Time frame: 1 day
Foot & Ankle computerized adaptive test (CAT)
Time frame: 2 & 4 weeks of treatment
Algometric test
Time frame: 4 weeks of treatment
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 4 Oct 2017.
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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.
Ron Ben-izhak, PHD principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic ultrasound in people with Plantar Fasciitis, run by Assuta Hospital Systems 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 5 inclusion and 10 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 4 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
Numerical Pain Rating Scale (NPRS) at morning (time frame: at morning after 4 weeks of treatment). 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 4 Oct 2017.