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CompletedNCT03254602ITUUpdated Dec 7, 2017Results posted

Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis

An interventional study of Intense Therapeutic Ultrasound Treatment in Plantar Fasciitis, Chronic, sponsored by University Foot and Ankle Foundation. Completed. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by University Foot and Ankle Foundation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.

Read the detailed description

Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.

02

Conditions studied

  • Plantar Fasciitis, Chronic
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Chronic Pain (>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
  • No History of surgery to the affected anatomy.
  • No alternative treatment procedures within the last 90 days.
  • Age: 18 - 85, depending on the study.
  • Unilateral Pain
  • Willingness to complete treatment and post treatment regimen as described.
  • Patients who have provided written and verbal informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
  • Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
  • Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
  • At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Intense Therapeutic Ultrasound Treatment

    Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.

    Device: Intense Therapeutic Ultrasound Treatment

Interventions

  • DeviceIntense Therapeutic Ultrasound Treatment

    Also known as: Guided Therapy Systems, Ardent Sound, GTS, ITU, Actisound

05

What researchers measure

Primary outcomes

  1. Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction

    Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.

    Time frame: At 12 weeks after the first treatment

Secondary outcomes

  1. Ultrasound Changes

    Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments

    Time frame: At 12 Weeks after the first treatment

  2. Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline

    Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)

    Time frame: At 12 Weeks after the first treatment

06

Results

Posted Nov 17, 2017
Limitations and caveats
Bias was mitigated as much as possible within the protocol by way of the blinding throughout the layers of patients and personnel involved in the study.

Participant flow

Participant flow — Overall Study
MilestoneIntense Therapeutic Ultrasound Treatment
Started33
Completed29
Not completed4
Withdrew: Lost to follow-up4

Outcome measures

PrimaryPatient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction

Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.

Time frame:
At 12 weeks after the first treatment
Reported as:
Number · Percent of Patients meeting criteria
Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction
Percent of Patients meeting criteriaIntense Therapeutic Ultrasound Treatment
Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction86
SecondaryUltrasound Changes

Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments

Time frame:
At 12 Weeks after the first treatment
Reported as:
Mean · percentage of Lesion Size Reduction
Ultrasound Changes
percentage of Lesion Size ReductionIntense Therapeutic Ultrasound Treatment
Ultrasound Changes56 (0 to 100)
SecondaryPercentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline

Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)

Time frame:
At 12 Weeks after the first treatment
Reported as:
Mean · percentage of Change
Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline
percentage of ChangeIntense Therapeutic Ultrasound Treatment
Mean % PF Pain Change-54 (-100 to 100)
Mean % Change in PF Hypoechoic Lesion Volume-56 (-100 to 100)

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intense Therapeutic Ultrasound Treatment0/29 (0%)0/29 (0%)0/29 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intense Therapeutic Ultrasound Treatment
<=18 years0
Between 18 and 65 years30
>=65 years3
Age, Continuous
Age, Continuous(years)Intense Therapeutic Ultrasound Treatment
Mean56 (31 to 73)
Sex: Female, Male
Sex: Female, Male(Participants)Intense Therapeutic Ultrasound Treatment
Female13
Male20
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Intense Therapeutic Ultrasound Treatment
Region of Enrollment
Region of Enrollment(Participants)Intense Therapeutic Ultrasound Treatment
United States33
Patients with Chronic Plantar Fasciitis where Standard of Care Therapy failed to Reduce Pain
Patients with Chronic Plantar Fasciitis where Standard of Care Therapy failed to Reduce Pain(Participants)Intense Therapeutic Ultrasound Treatment
Count of participants33
07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22. PubMed 17224484 ↗
  • Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039. PubMed 20115948 ↗
  • Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88. PubMed 17372061 ↗
  • Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x. PubMed 18429926 ↗
  • Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004. PubMed 12696985 ↗
  • Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305. PubMed 16801514 ↗

Study documents

  • Informed consent form · May 26, 2016
  • Study protocol · Apr 27, 2016
  • Statistical analysis plan · May 26, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03254602
Lead sponsor
University Foot and Ankle Foundation
Collaborators
Guided Therapy Systems
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Aug 4, 2016
Primary completion
Apr 10, 2017
Completion
Apr 10, 2017
Results posted
Nov 17, 2017
Last update
Dec 7, 2017

Study contacts

Bob Baravarian, DPM
principal investigator · University Foot and Ankle Foundation

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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