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
The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).
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.
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 →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.
Exclusion Criteria:
will receive stretching guidance and high level active Ultrasound
Device: Therapeutic ultrasound
will receive stretching guidance and very low level of Ultrasound
Device: Therapeutic ultrasound
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
NPRS during the day
pain level during the day.
Time frame: 1 day
Foot & Ankle computerized adaptive test (CAT)
Questionnaire of quality of life
Time frame: 2 & 4 weeks of treatment
Algometric test
Average of 3 testing of Pressure on the medial tuberosity
Time frame: 4 weeks of treatment
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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Assuta Hospital Systems