Trial Outcomes & Findings for Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis (NCT NCT03254602)
NCT ID: NCT03254602
Last Updated: 2017-12-07
Results Overview
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.
COMPLETED
NA
33 participants
At 12 weeks after the first treatment
2017-12-07
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intense Therapeutic Ultrasound Treatment
n=33 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=33 Participants
|
|
Age, Continuous
|
56 years
n=33 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=33 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=33 Participants
|
|
Patients with Chronic Plantar Fasciitis where Standard of Care Therapy failed to Reduce Pain
|
33 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: At 12 weeks after the first treatmentPopulation: Patients receiving 2 Intense Therapeutic Ultrasound Treatments, beginning 12 Weeks ago.
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.
Outcome measures
| Measure |
Intense Therapeutic Ultrasound Treatment
n=29 Participants
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
|
|---|---|
|
Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction
|
86 Percent of Patients meeting criteria
|
SECONDARY outcome
Timeframe: At 12 Weeks after the first treatmentPopulation: Patients receiving 2 Intense Therapeutic Ultrasound Treatments - Average % Volume Reduction of Hypoechoic Plantar Fascia Lesions
Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments
Outcome measures
| Measure |
Intense Therapeutic Ultrasound Treatment
n=26 Participants
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
|
|---|---|
|
Ultrasound Changes
|
56 percentage of Lesion Size Reduction
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: At 12 Weeks after the first treatmentPopulation: Patients receiving 2 Intense Therapeutic Ultrasound treatments beginning 12 weeks ago
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)
Outcome measures
| Measure |
Intense Therapeutic Ultrasound Treatment
n=26 Participants
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
|
|---|---|
|
Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline
Mean % PF Pain Change
|
-54 percentage of Change
Interval -100.0 to 100.0
|
|
Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline
Mean % Change in PF Hypoechoic Lesion Volume
|
-56 percentage of Change
Interval -100.0 to 100.0
|
Adverse Events
Intense Therapeutic Ultrasound Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place