Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plantar Fasciitis and Therapeutic Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679326
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems

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

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Device: Therapeutic ultrasound Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Double blinded RCT
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Treating Plantar Fasciitis With Therapeutic Ultrasound
Study Start Date : May 2015
Actual Primary Completion Date : May 28, 2017
Actual Study Completion Date : May 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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



Primary Outcome Measures :
  1. Numerical Pain Rating Scale (NPRS) at morning [ Time Frame: at morning after 4 weeks of treatment ]
    pain level at the heel at the first step in the morning.


Secondary Outcome Measures :
  1. NPRS during the day [ Time Frame: 1 day ]
    pain level during the day.

  2. Foot & Ankle computerized adaptive test (CAT) [ Time Frame: 2 & 4 weeks of treatment ]
    Questionnaire of quality of life

  3. Algometric test [ Time Frame: 4 weeks of treatment ]
    Average of 3 testing of Pressure on the medial tuberosity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679326


Locations
Layout table for location information
Israel
Maccabee Health Services Physical therapy Clinic
Rehovot, Darom, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Layout table for investigator information
Principal Investigator: Ron Ben-izhak, PHD Maccabi Healthcare Services, Israel
Layout table for additonal information
Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT02679326    
Other Study ID Numbers: 4/2015
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: January 2017
Keywords provided by Assuta Hospital Systems:
Therapeutic ultrasound, Treatment, Plantar fasciitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases