Long Duration Therapeutic Ultrasound on Tendon Injuries

Sponsor

ZetrOZ, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02340273

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury.

Condition or Disease	Intervention/Treatment	Phase
Tendon Injuries Musculoskeletal Pain	Device: Therapeutic ultrasound Device: Placebo therapeutic ultrasound	N/A

Detailed Description

The ability of long duration therapeutic ultrasound to reduce pain, increase strength, and improve quality of life for patients with tendon injury [e.g. tendinopathy of the elbow (medial or lateral], Achilles tendon, or patellar tendon) will be assessed. During the 7-week protocol, participants will receive 4 continuous hours of therapy daily.

For the first week, baseline data will be collected as participants report pain scores (VAS) in the morning, noon, and night. During the next 6 weeks, participants will self-apply the device each day and record their pain score (VAS) before and treatment; and record their pain score (VAS) while performing specified movements designed to evaluate tendon rehabilitation. At bi-weekly site visits, strength measurements will be performed on the injured and uninjured limb. Participants will also complete a standardized questionnaire to assess disability due to the specific tendon injury at baseline and study conclusion.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Long Duration Therapeutic Ultrasound on Tendon Injuries

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapeutic ultrasound device Patients receive treatment from the long duration therapeutic ultrasound device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.	Device: Therapeutic ultrasound Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2. Other Names: Therapeutic ultrasound (active) wearable ultrasound device long duration ultrasound LITUS device long duration low intensity device
Placebo Comparator: Placebo therapeutic ultrasound device Patients receive the "sham" long duration therapeutic ultrasound device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.	Device: Placebo therapeutic ultrasound Patients receive "sham" therapeutic ultrasound daily for 4 hours.

Arm

Intervention/Treatment

Experimental: Therapeutic ultrasound device

Patients receive treatment from the long duration therapeutic ultrasound device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Device: Therapeutic ultrasound

Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.

Other Names:

Therapeutic ultrasound (active)

wearable ultrasound device

long duration ultrasound

LITUS device

long duration low intensity device

Placebo Comparator: Placebo therapeutic ultrasound device

Patients receive the "sham" long duration therapeutic ultrasound device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound.

Device: Placebo therapeutic ultrasound

Patients receive "sham" therapeutic ultrasound daily for 4 hours.

Outcome Measures

Primary Outcome Measures

Change in pain on the visual analog scale (VAS) from baseline to study conclusion [Baseline, Week 7]

Secondary Outcome Measures

Pressure point sensitivity as measured through algometry [Baseline, Week 7]
Change in pain during functional testing as measured by VAS [Baseline, Week 7]
Change in strength of limb through dynamometry [Baseline, Week 7]
Quality of life and functioning through limb-specific standardized questionnaires [Baseline, Week 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has been diagnosed with tendinitis in the elbow (medial or lateral epicondyles), patella, or Achilles tendon based on physical examination by a healthcare practitioner and medical history. Physical examination must include one of the following: assessment of pain during manual movements of the injured limb (e.g. a positive Mill's Test [Wadsworth, 1987] for elbow tendinitis), or local tenderness upon palpation over the tendon
Experience tendon pain greater than 1 (using the VAS scale of 0-10) during the week preceding study screening
Between 18 and 70 years of age
Willing and able to self-administer the study device to the treatment area daily
Have access to a mobile phone or camera to take a picture of the treatment area immediately after use of the device
Body Mass Index (BMI) is less than or equal to 34.0
Agree to document all pain medications and associated dosages during participation in the study.
If taking prescription pain medication, agree to keep dosage constant (unchanged) during participation in the study.
Agree not to use any topical solution such as analgesic cream or ointment on the treatment area during participation in the study

Exclusion Criteria:

Subjects that cannot speak, read or write English
History or current diagnosis of tendinosis or a tendon tear
Known neuropathy (nerve damage that affects the treatment area)
Surgery in the treatment area within the last 6 months
Non-ambulatory (unable to walk)
Prisoner
Pregnant
Have a pacemaker
Malignancy in the treatment area
Refuse to discontinue all other interventional treatment modalities (i.e. transcutaneous electrical nerve stimulation (TENS), electrical stimulation, or other ultrasound therapy) during the study
Local corticosteroid or platelet-rich plasma (PRP) injection within the past 3 months
Clinically significant or unstable medical or psychological conditions that would compromise participation in the study
Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Involved in any injury-related litigation in the treatment area
Open sores or wounds in the treatment area that would prevent use of the device
Arthritis in the treatment area
Carpal tunnel syndrome (if subject has elbow tendinitis)