Plantar Fasciitis and Therapeutic Ultrasound

The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound

The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Device: Therapeutic ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Darom
    • Rehovot, Darom, Israel
      • Maccabee Health Services Physical therapy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; will receive stretching guidance and high level active Ultrasound	Device: Therapeutic ultrasound
Placebo Comparator: control group; will receive stretching guidance and very low level of Ultrasound	Device: Therapeutic ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	2 & 4 weeks of treatment
Algometric test	Average of 3 testing of Pressure on the medial tuberosity	4 weeks of treatment

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems
• Investigators: Principal Investigator: Ron Ben-izhak, PHD, Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 28, 2017
• Study Completion (Actual): May 28, 2017

Study Registration Dates

• First Submitted: February 7, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Therapeutic ultrasound, Treatment, Plantar fasciitis
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 4/2015