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CompletedNCT02679326Updated Oct 4, 2017

Plantar Fasciitis and Therapeutic Ultrasound

An interventional study of Therapeutic ultrasound in Plantar Fasciitis, sponsored by Assuta Hospital Systems. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-04.

Sponsored by Assuta Hospital Systems · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Plantar Fasciitis

Keywords

  • Therapeutic ultrasound, Treatment, Plantar fasciitis
03

In context

Fasciitis

235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.

This study's enrollment of 51 is close to the median of 54 across 192 interventional studies indexed under Fasciitis.

Browse Fasciitis studies →

Lead sponsor

Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Pregnancy.
  • Foot infection or diabetic foot.
  • Stress fractures of the heel.
  • Unavailability in advance to participate in research.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    study group

    will receive stretching guidance and high level active Ultrasound

    Device: Therapeutic ultrasound

  • Placebo comparator
    control group

    will receive stretching guidance and very low level of Ultrasound

    Device: Therapeutic ultrasound

Interventions

  • DeviceTherapeutic ultrasound
06

What researchers measure

Primary outcomes

  1. Numerical Pain Rating Scale (NPRS) at morning

    pain level at the heel at the first step in the morning.

    Time frame: at morning after 4 weeks of treatment

Secondary outcomes

  1. NPRS during the day

    pain level during the day.

    Time frame: 1 day

  2. Foot & Ankle computerized adaptive test (CAT)

    Questionnaire of quality of life

    Time frame: 2 & 4 weeks of treatment

  3. Algometric test

    Average of 3 testing of Pressure on the medial tuberosity

    Time frame: 4 weeks of treatment

07

Study locations

1 site
  • Maccabee Health Services Physical therapy Clinic
    Rehovot, Darom, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02679326
Lead sponsor
Assuta Hospital Systems
Responsible party
Sponsor
First posted
Feb 10, 2016
Start date
May 2015
Primary completion
May 28, 2017
Completion
May 28, 2017
Last update
Oct 4, 2017

Study contacts

Ron Ben-izhak, PHD
principal investigator · Maccabi Healthcare Services, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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