Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with thumb carpometacarpal (CMC) joint osteoarthritis (OA). Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks. Pain and function questionnaires will be obtained for all patients at enrollment, four weeks, and six weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
PEMF device wear overnight daily for four weeks
Sham PEMF device wear overnight daily for four weeks. Sham PEMF devices do not emit a radiofrequency electromagnetic field but are otherwise identical in appearance to the PEMF device
Stanford Medicine Outpatient Center
Redwood City, California, United States
Numeric Pain Rating Scale (NPRS)
NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time frame: 4 weeks
Numeric Pain Rating Scale (NPRS)
NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time frame: 6 weeks
Patient-Rated Wrist/Hand Evaluation (PRWHE)
PRWHE consists of 15 questions on symptoms with daily activities scored on a 11-point numeric scale, in which '0' represents no difficulty or pain. The total score is then scaled from '0' representing no disability to '100' representing most severe disability.
Time frame: 4 weeks
Single Assessment Numeric Evaluation (SANE)
SANE is a single-question outcome measure that asks patient to rate their function of the treated area on a scale from '0' to '100' ("For the problem that you are seeking treatment for today, out of 100% (100% being normal), how would you rate the function of your RIGHT/LEFT thumb today?").
Time frame: 4 weeks
Patient-Rated Wrist/Hand Evaluation (PRWHE)
PRWHE consists of 15 questions on symptoms with daily activities scored on a 11-point numeric scale, in which '0' represents no difficulty or pain. The total score is then scaled from '0' representing no disability to '100' representing most severe disability.
Time frame: 6 weeks
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Single Assessment Numeric Evaluation (SANE)
SANE is a single-question outcome measure that asks patient to rate their function of the treated area on a scale from '0' to '100' ("For the problem that you are seeking treatment for today, out of 100% (100% being normal), how would you rate the function of your RIGHT/LEFT thumb today?").
Time frame: 6 weeks