Plantar Fasciitis and Therapeutic Ultrasound

NCT ID: NCT02679326

Last Updated: 2017-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-05-28

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.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

study group

will receive stretching guidance and high level active Ultrasound

Group Type: EXPERIMENTAL

Therapeutic ultrasound

Intervention Type: DEVICE

control group

will receive stretching guidance and very low level of Ultrasound

Group Type: PLACEBO_COMPARATOR

Therapeutic ultrasound

Intervention Type: DEVICE

Interventions

Therapeutic ultrasound

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assuta Hospital Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Ben-izhak, PHD

Role: PRINCIPAL_INVESTIGATOR

Maccabi Healthcare Services, Israel

Locations

Maccabee Health Services Physical therapy Clinic

Rehovot, Southern District, Israel

Countries

Israel

Other Identifiers

4/2015

Identifier Type: -

Identifier Source: org_study_id