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Plantar Fasciitis and Therapeutic Ultrasound

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Therapeutic ultrasound
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Therapeutic ultrasound, Treatment, Plantar fasciitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maccabee Health Services Physical therapy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

will receive stretching guidance and high level active Ultrasound

will receive stretching guidance and very low level of Ultrasound

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale (NPRS) at morning
pain level at the heel at the first step in the morning.

Secondary Outcome Measures

NPRS during the day
pain level during the day.
Foot & Ankle computerized adaptive test (CAT)
Questionnaire of quality of life
Algometric test
Average of 3 testing of Pressure on the medial tuberosity

Full Information

First Posted
February 7, 2016
Last Updated
October 3, 2017
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02679326
Brief Title
Plantar Fasciitis and Therapeutic Ultrasound
Official Title
The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 28, 2017 (Actual)
Study Completion Date
May 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Therapeutic ultrasound, Treatment, Plantar fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Double blinded RCT
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
will receive stretching guidance and high level active Ultrasound
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
will receive stretching guidance and very low level of Ultrasound
Intervention Type
Device
Intervention Name(s)
Therapeutic ultrasound
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS) at morning
Description
pain level at the heel at the first step in the morning.
Time Frame
at morning after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
NPRS during the day
Description
pain level during the day.
Time Frame
1 day
Title
Foot & Ankle computerized adaptive test (CAT)
Description
Questionnaire of quality of life
Time Frame
2 & 4 weeks of treatment
Title
Algometric test
Description
Average of 3 testing of Pressure on the medial tuberosity
Time Frame
4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Ben-izhak, PHD
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maccabee Health Services Physical therapy Clinic
City
Rehovot
State/Province
Darom
Country
Israel

12. IPD Sharing Statement

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Plantar Fasciitis and Therapeutic Ultrasound

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