Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

NCT05315297 | Completed Results FDA Device

• 1 other identifier: 64143
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Numeric Pain Rating Scale (NPRS)

  6 weeks

• Patient-Rated Wrist/Hand Evaluation (PRWHE)

  4 weeks

• Single Assessment Numeric Evaluation (SANE)

  4 weeks

• Patient-Rated Wrist/Hand Evaluation (PRWHE)

  6 weeks

• Single Assessment Numeric Evaluation (SANE)

  6 weeks

Study Arms (2)

PEMF device

EXPERIMENTAL

Device: PEMF device

Sham PEMF device

SHAM COMPARATOR

Device: Sham PEMF device

Interventions

PEMF device DEVICE

PEMF device wear overnight daily for four weeks

Also known as: ActiPatch

PEMF device

Sham PEMF device 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

Sham PEMF device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Results Point of Contact

• Title: Dr. Raymond Chou, MD
• Organization: Stanford University School of Medicine

raymond.chou@stanford.edu

650-723-5256

Study Officials

• Raymond Chou, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 7, 2022
• Study Start: June 20, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 3, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)