Plantar Fasciitis
Conditions
Keywords
Therapeutic ultrasound, Treatment, Plantar fasciitis
Brief summary
The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).
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.
Interventions
DEVICETherapeutic ultrasound
Sponsors
Assuta Hospital Systems
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Double blinded RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NPRS) at morning | at morning after 4 weeks of treatment | pain level at the heel at the first step in the morning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NPRS during the day | 1 day | pain level during the day. |
| Foot & Ankle computerized adaptive test (CAT) | 2 & 4 weeks of treatment | Questionnaire of quality of life |
| Algometric test | 4 weeks of treatment | Average of 3 testing of Pressure on the medial tuberosity |
Countries
Israel
Outcome results
None listed