The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
James A Haley Veterans Hospital
Tampa, Florida, United States
RECRUITINGChange in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Change in the self described pain units on a scale by patient at baseline and post-
Time frame: Through study completion, average of 8 weeks
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).
Time frame: Time Frame: Through study completion, average of 8 weeks
Change in Global Rating of Change (GROC) on a Scale (-7 to +7)
Subject-reported change in overall pain on a scale, -7 = worst, +7 = best.
Time frame: Through study completion, average of 24 weeks.
Change in the Pain & Sleep Questionnaire (PSQ-3)
Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact
Time frame: Through study completion, average of 24 weeks.
Change in Depression Anxiety Stress Scale (DASS21)
Subject-reported measures of depression, anxiety, and stress on a scale of 0-3, 0 being not applicable, 1 meaning applicable to some degree, 2 meaning applicable often, and 3 meaning applicable most of the time. Questions are divided into three categories: depression, anxiety, and stress.
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Time frame: Through study completion, average of 24 weeks.