Plantar Fasciitis, Chronic
Conditions
Brief 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.
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.
Interventions
Sponsors
Guided Therapy Systems
University Foot and Ankle Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction | At 12 weeks after the first treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Changes | At 12 Weeks after the first treatment | Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments |
| Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline | At 12 Weeks after the first treatment | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Intense Therapeutic Ultrasound Treatment | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Intense Therapeutic Ultrasound Treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Age, Continuous | 56 years | — |
| Patients with Chronic Plantar Fasciitis where Standard of Care Therapy failed to Reduce Pain | 33 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 33 Participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
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
Population: Patients receiving 2 Intense Therapeutic Ultrasound Treatments, beginning 12 Weeks ago.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intense Therapeutic Ultrasound Treatment | Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction | 86 Percent of Patients meeting criteria |
Secondary
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
Population: Patients receiving 2 Intense Therapeutic Ultrasound treatments beginning 12 weeks ago
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intense Therapeutic Ultrasound Treatment | Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline | Mean % PF Pain Change | -54 percentage of Change |
| Intense Therapeutic Ultrasound Treatment | Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline | Mean % Change in PF Hypoechoic Lesion Volume | -56 percentage of Change |
Secondary
Ultrasound Changes
Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments
Time frame: At 12 Weeks after the first treatment
Population: Patients receiving 2 Intense Therapeutic Ultrasound Treatments - Average % Volume Reduction of Hypoechoic Plantar Fascia Lesions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intense Therapeutic Ultrasound Treatment | Ultrasound Changes | 56 percentage of Lesion Size Reduction |