Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Conditions
-----------------
Thumb Osteoarthritis

Intervention / Treatment
-----------------
* Device: PEMF device
* Device: Sham PEMF device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically identified CMC OA reported pain intensity during activities of daily living less than 7 on the Numeric Pain Rating Scale (NPRS) Exclusion Criteria: pregnant unable to consent with current infection in hand or upper extremity have had prior fracture, significant hand injury, tenosynovitis, complex regional pain syndrome, and/or Dupuytren's disease affecting the thumb history of surgical or procedural intervention for CMC OA in the hand of study interest do not speak English have hand or wrist implants have heart or brain implants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEMF device<br> | Device: PEMF device<br>* PEMF device wear overnight daily for four weeks<br>* Other names: ActiPatch;|
| Sham Comparator: Sham PEMF device<br> | Device: Sham PEMF device<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 4 and 6 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?). | 4 and 6 weeks |