search
Back to results

Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Primary Purpose

Thumb Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEMF device
Sham PEMF device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Medicine Outpatient CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PEMF device

Sham PEMF device

Arm Description

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

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").
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.
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?").

Full Information

First Posted
March 15, 2022
Last Updated
June 20, 2023
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT05315297
Brief Title
Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis
Official Title
Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEMF device
Arm Type
Experimental
Arm Title
Sham PEMF device
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
PEMF device
Other Intervention Name(s)
ActiPatch
Intervention Description
PEMF device wear overnight daily for four weeks
Intervention Type
Device
Intervention Name(s)
Sham PEMF device
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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").
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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").
Time Frame
6 weeks
Title
Patient-Rated Wrist/Hand Evaluation (PRWHE)
Description
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.
Time Frame
4 and 6 weeks
Title
Single Assessment Numeric Evaluation (SANE)
Description
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?").
Time Frame
4 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Chou, MD
Phone
(650) 723-5256
Email
aleary18@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Kenney
Email
dkenney@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Chou, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Medicine Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Chou, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

We'll reach out to this number within 24 hrs