Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Not Applicable

Completed

• Conditions: Thumb Osteoarthritis
• Interventions: Device: Sham PEMF device; Device: PEMF device

• Registration Number: NCT05315297
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-07
• Study Start: 2023-06-20
• Status Verified: 2024-08
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham PEMF device	Sham PEMF device	-
PEMF device	PEMF device	-

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	4 weeks	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").

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	6 weeks	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").
Single Assessment Numeric Evaluation (SANE)	4 and 6 weeks	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?").
Patient-Rated Wrist/Hand Evaluation (PRWHE)	4 and 6 weeks	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.

Trial Locations

Locations (1)

Stanford Medicine Outpatient Center; 🇺🇸 Redwood City, California, United States