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Completed

NCT Number: NCT02679326

Plantar Fasciitis and Therapeutic Ultrasound

The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maccabee Health Services Physical therapy Clinic

Rehovot, Southern District, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

Therapeutic Ultrasound

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. NPRS during the day

    Time frame: 1 day

    pain level during the day.

  2. Foot & Ankle computerized adaptive test (CAT)

    Time frame: 2 & 4 weeks of treatment

    Questionnaire of quality of life

  3. Algometric test

    Time frame: 4 weeks of treatment

    Average of 3 testing of Pressure on the medial tuberosity

Sponsors and collaborators

Lead sponsor

Assuta Hospital Systems

Other

Registry information

Official study title

The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2016
Registry last updated
Oct 4, 2017

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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