Clinical trial NCT02679326: Plantar Fasciitis and Therapeutic Ultrasound
Official title: The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Therapeutic ultrasound, Treatment, Plantar fasciitis
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Double blinded RCT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS) at morning
timeFrame: at morning after 4 weeks of treatment
Secondary outcomes:
measure: NPRS during the day
timeFrame: 1 day
measure: Foot & Ankle computerized adaptive test (CAT)
timeFrame: 2 & 4 weeks of treatment
measure: Algometric test
timeFrame: 4 weeks of treatment
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Maccabee Health Services Physical therapy Clinic
state: Darom
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Ron Ben-izhak, PHD
role: PRINCIPAL_INVESTIGATOR
References: