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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEMF device | Experimental |
| |
| Sham PEMF device | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEMF device | Device | PEMF device wear overnight daily for four weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Chou, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medicine Outpatient Center | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEMF Device | PEMF device: PEMF device wear overnight daily for four weeks |
| FG001 | Sham PEMF 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEMF Device | PEMF device: PEMF device wear overnight daily for four weeks |
| BG001 | Sham PEMF 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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"). | Excludes participants with missing data | Posted | Median | Full Range | units on a scale | 4 weeks |
|
Data collected weekly for 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEMF Device | PEMF device: PEMF device wear overnight daily for four weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin allergy/blistering | Skin and subcutaneous tissue disorders | Systematic Assessment | Attributed to the adhesive tape used to secure the device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Chou, MD | Stanford University School of Medicine | 650-723-5256 | raymond.chou@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2022 | Jul 3, 2025 | Prot_SAP_000.pdf |
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| 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 |
|
| 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 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 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. | 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?"). | 6 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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"). | Median | Full Range | units on a scale |
|
| 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. | Median | Full Range | score on a scale |
|
| 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?"). | Median | Full Range | units on a scale |
|
|
|
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| Secondary | 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"). | Excludes participants with missing data | Posted | Median | Full Range | units on a scale | 6 weeks |
|
|
|
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| Secondary | 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. | Excludes participants with missing data | Posted | Median | Full Range | score on a scale | 4 weeks |
|
|
|
|
| Secondary | 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?"). | Excludes participants with missing data | Posted | Median | Full Range | units on a scale | 4 weeks |
|
|
|
|
| Secondary | 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. | Excludes participants with missing data | Posted | Median | Full Range | score on a scale | 6 weeks |
|
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|
|
| Secondary | 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?"). | Excludes participants with missing data | Posted | Median | Full Range | units on a scale | 6 weeks |
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| 31 |
| 0 |
| 31 |
| 5 |
| 31 |
| EG001 | Sham PEMF 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 | 0 | 30 | 0 | 30 | 4 | 30 |
|
| Increased thumb pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Increased Dupuytren's contracture | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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