Thumb Osteoarthritis
Conditions
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.
Interventions
DEVICEPEMF device
PEMF device wear overnight daily for four weeks
DEVICESham 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
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Patient-Rated Wrist/Hand Evaluation (PRWHE) | 4 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. |
| Single Assessment Numeric Evaluation (SANE) | 4 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?). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEMF Device PEMF device: PEMF device wear overnight daily for four weeks | 31 |
| 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 | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | PEMF Device | Total | Sham PEMF Device |
|---|---|---|---|
| Age, Continuous | 67 years | 66 years | 65 years |
| Numeric Pain Rating Scale (NPRS) | 5 units on a scale | 5 units on a scale | 5 units on a scale |
| Patient Rated Wrist/Hand Evaluation (PRWHE) | 47 score on a scale | 48 score on a scale | 48 score on a scale |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 31 participants | 61 participants | 30 participants |
| Sex: Female, Male Female | 21 Participants | 46 Participants | 25 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 5 Participants |
| Single Assessment Numeric Evaluation (SANE) | 70 units on a scale | 65 units on a scale | 65 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 5 / 31 | 4 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
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).
Time frame: 4 weeks
Population: Excludes participants with missing data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEMF Device | Numeric Pain Rating Scale (NPRS) | 3 units on a scale |
| Sham PEMF Device | Numeric Pain Rating Scale (NPRS) | 3 units on a scale |
p-value: 0.87Wilcoxon (Mann-Whitney)
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).
Time frame: 6 weeks
Population: Excludes participants with missing data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEMF Device | Numeric Pain Rating Scale (NPRS) | 3 units on a scale |
| Sham PEMF Device | Numeric Pain Rating Scale (NPRS) | 4 units on a scale |
p-value: 0.13Wilcoxon (Mann-Whitney)
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.
Time frame: 4 weeks
Population: Excludes participants with missing data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEMF Device | Patient-Rated Wrist/Hand Evaluation (PRWHE) | 39 score on a scale |
| Sham PEMF Device | Patient-Rated Wrist/Hand Evaluation (PRWHE) | 39 score on a scale |
p-value: 0.78Wilcoxon (Mann-Whitney)
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.
Time frame: 6 weeks
Population: Excludes participants with missing data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEMF Device | Patient-Rated Wrist/Hand Evaluation (PRWHE) | 35 score on a scale |
| Sham PEMF Device | Patient-Rated Wrist/Hand Evaluation (PRWHE) | 43 score on a scale |
p-value: 0.37Wilcoxon (Mann-Whitney)
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?).
Time frame: 4 weeks
Population: Excludes participants with missing data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEMF Device | Single Assessment Numeric Evaluation (SANE) | 75 units on a scale |
| Sham PEMF Device | Single Assessment Numeric Evaluation (SANE) | 75 units on a scale |
p-value: 0.59Wilcoxon (Mann-Whitney)
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?).
Time frame: 6 weeks
Population: Excludes participants with missing data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEMF Device | Single Assessment Numeric Evaluation (SANE) | 73 units on a scale |
| Sham PEMF Device | Single Assessment Numeric Evaluation (SANE) | 65 units on a scale |
p-value: 0.19Wilcoxon (Mann-Whitney)