Clinical Trial: Plantar Fasciitis and Therapeutic Ultrasound

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound

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

Detailed Summary: 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.
Sponsor: Assuta Hospital Systems

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NPRS during the day [ Time Frame: 1 day ]
    pain level during the day.
  • Foot & Ankle computerized adaptive test (CAT) [ Time Frame: 2 & 4 weeks of treatment ]
    Questionnaire of quality of life
  • Algometric test [ Time Frame: 4 weeks of treatment ]
    Average of 3 testing of Pressure on the medial tuberosity


Original Secondary Outcome: Same as current

Information By: Assuta Hospital Systems

Dates:
Date Received: February 7, 2016
Date Started: May 2015
Date Completion: August 2017
Last Updated: January 26, 2017
Last Verified: January 2017