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Trial Outcomes & Findings for Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction (NCT NCT03255655)

NCT ID: NCT03255655

Last Updated: 2017-12-13

Results Overview

Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

12 weeks after 1st Treatment

Results posted on

2017-12-13

Participant Flow

Patients 18 - 85 years previously diagnosed with unilateral Chronic Plantar Fasciitis (\>90 days), where Standard of Care therapies had failed to reduce pain.

Participant milestones

Participant milestones
Measure
ITU Treatment for Chronic Plantar Fasciitis
Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Sham ITU Treatment for Chronic Plantar Fasciitis
Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Overall Study
STARTED
29
12
Overall Study
COMPLETED
22
8
Overall Study
NOT COMPLETED
7
4

Reasons for withdrawal

Reasons for withdrawal
Measure
ITU Treatment for Chronic Plantar Fasciitis
Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Sham ITU Treatment for Chronic Plantar Fasciitis
Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Overall Study
Lost to Follow-up
7
4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ITU Treatment for Chronic Plantar Fasciitis
n=29 Participants
Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Sham ITU Treatment for Chronic Plantar Fasciitis
n=12 Participants
Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Total
n=41 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=29 Participants
0 Participants
n=12 Participants
0 Participants
n=41 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
n=29 Participants
11 Participants
n=12 Participants
39 Participants
n=41 Participants
Age, Categorical
>=65 years
1 Participants
n=29 Participants
1 Participants
n=12 Participants
2 Participants
n=41 Participants
Age, Continuous
54 years
n=29 Participants
47 years
n=12 Participants
51 years
n=41 Participants
Sex: Female, Male
Female
24 Participants
n=29 Participants
8 Participants
n=12 Participants
32 Participants
n=41 Participants
Sex: Female, Male
Male
5 Participants
n=29 Participants
4 Participants
n=12 Participants
9 Participants
n=41 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
29 participants
n=29 Participants
12 participants
n=12 Participants
41 participants
n=41 Participants

PRIMARY outcome

Timeframe: 12 weeks after 1st Treatment

Population: Total population of respondents at 12 weeks.

Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.

Outcome measures

Outcome measures
Measure
ITU Treatment for Chronic Plantar Fasciitis
n=22 Participants
Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Sham ITU Treatment for Chronic Plantar Fasciitis
n=8 Participants
Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Average Percentage of Change as Reported Using Foot Function Index Pain Subscale
-54 percentage of Change
Interval -100.0 to 100.0
-25 percentage of Change
Interval -100.0 to 100.0

PRIMARY outcome

Timeframe: 12 Weeks after the first Treatment

Population: Male and Female previously diagnosed with Chronic Plantar Fasciitis, between the age of 18 and 85.

Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).

Outcome measures

Outcome measures
Measure
ITU Treatment for Chronic Plantar Fasciitis
n=22 Participants
Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Sham ITU Treatment for Chronic Plantar Fasciitis
n=8 Participants
Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart. Intense Therapeutic Ultrasound Treatment - ITU
Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging
-81 percentage of Hypoechoic Lesion Change
Standard Error 8
26 percentage of Hypoechoic Lesion Change
Standard Error 4

Adverse Events

ITU Treatment for Chronic Plantar Fasciitis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham ITU Treatment for Chronic Plantar Fasciitis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rich Amodei, RDMS

Guided Therapy Systems

Phone: 480-649-8587

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place