Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

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 Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Device: PEMF device; Device: Sham PEMF device

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Chou, MD; Phone Number: (650) 723-5256; Email: aleary18@stanford.edu
• Study Contact Backup: Name: Deborah Kenney; Email: dkenney@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Medicine Outpatient Center
      • Contact: Raymond Chou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham PEMF device	Device: Sham PEMF device; 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
Experimental: PEMF device	Device: PEMF device; PEMF device wear overnight daily for four weeks; Other Names: ActiPatch

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Raymond Chou, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 64143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No