Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

NCT ID: NCT05315297

Last Updated: 2025-08-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thumb Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PEMF device

Group Type EXPERIMENTAL

PEMF device

Intervention Type DEVICE

PEMF device wear overnight daily for four weeks

Sham PEMF device

Group Type SHAM_COMPARATOR

Sham PEMF device

Intervention Type 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

Interventions

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PEMF device

PEMF device wear overnight daily for four weeks

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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ActiPatch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Raymond Chou

Clinical Assistant Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Chou, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Medicine Outpatient Center

Redwood City, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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64143

Identifier Type: -

Identifier Source: org_study_id

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