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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | will receive stretching guidance and high level active Ultrasound |
|
| control group | Placebo Comparator | will receive stretching guidance and very low level of Ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic ultrasound | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Rating Scale (NPRS) at morning | pain level at the heel at the first step in the morning. | at morning after 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| NPRS during the day | pain level during the day. | 1 day |
| Foot & Ankle computerized adaptive test (CAT) | Questionnaire of quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Ben-izhak, PHD | Maccabi Healthcare Services, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maccabee Health Services Physical therapy Clinic | Rehovot | Southern District | Israel |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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Double blinded RCT
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| 2 & 4 weeks of treatment |
| Algometric test | Average of 3 testing of Pressure on the medial tuberosity | 4 weeks of treatment |