Trial Outcomes & Findings for ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction (NCT NCT03255733)

Results Overview

Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

12 weeks after 1st Treatment

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Intense Therapeutic Ultrasound Treatment Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart. Intense Therapeutic Ultrasound Treatment
Overall Study STARTED	29
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intense Therapeutic Ultrasound Treatment Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 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

Baseline characteristics by cohort
Measure	Intense Therapeutic Ultrasound Treatment n=29 Participants Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart. Intense Therapeutic Ultrasound Treatment
Age, Categorical <=18 years	0 Participants n=29 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=29 Participants
Age, Categorical >=65 years	1 Participants n=29 Participants
Sex: Female, Male Female	12 Participants n=29 Participants
Sex: Female, Male Male	17 Participants n=29 Participants
Region of Enrollment United States	29 Participants n=29 Participants

PRIMARY outcome

Timeframe: 12 weeks after 1st Treatment

Population: Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment

Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).

Outcome measures

Outcome measures
Measure	Intense Therapeutic Ultrasound Treatment n=25 Participants Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart. Intense Therapeutic Ultrasound Treatment
Percentage of Patients Reporting at Least 25% Overall Pain Reduction	88 percentage of patients with less pain

SECONDARY outcome

Timeframe: 12 weeks after 1st Treatment

Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)

Outcome measures

Outcome measures
Measure	Intense Therapeutic Ultrasound Treatment n=25 Participants Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart. Intense Therapeutic Ultrasound Treatment
Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities	-58 percentage of reported pain change Interval -100.0 to 100.0

Adverse Events

Intense Therapeutic Ultrasound Treatment

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place