Plantar Fasciitis and Therapeutic Ultrasound

Plantar Fasciitis Clinical Trial

Official title:

The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679326
• Other study ID #: 4/2015
• Status: Completed
• Phase: N/A
• First received: February 7, 2016
• Last updated: October 3, 2017
• Start date: May 2015
• Est. completion date: May 28, 2017

Study information

• Verified date: January 2017
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 28, 2017
• Est. primary completion date: May 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• Therapeutic ultrasound

Locations

Country	Name	City	State
Israel	Maccabee Health Services Physical therapy Clinic	Rehovot	Darom

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NPRS during the day	pain level during the day.	1 day
Secondary	Foot & Ankle computerized adaptive test (CAT)	Questionnaire of quality of life	2 & 4 weeks of treatment
Secondary	Algometric test	Average of 3 testing of Pressure on the medial tuberosity	4 weeks of treatment