Trial Outcomes & Findings for Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis (NCT NCT05315297)

NCT ID: NCT05315297

Last Updated: 2025-08-03

Results Overview

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").

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2025-08-03

Participant Flow

Participant milestones

Measure	PEMF Device PEMF device: PEMF device wear overnight daily for four weeks	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
Overall Study STARTED	31	30
Overall Study Completed 4 Weeks	26	28
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	PEMF Device PEMF device: PEMF device wear overnight daily for four weeks	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
Overall Study Lost to Follow-up	6	4
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PEMF Device n=31 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=30 Participants 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	Total n=61 Participants Total of all reporting groups
Age, Continuous	67 years n=31 Participants	65 years n=30 Participants	66 years n=61 Participants
Sex: Female, Male Female	21 Participants n=31 Participants	25 Participants n=30 Participants	46 Participants n=61 Participants
Sex: Female, Male Male	10 Participants n=31 Participants	5 Participants n=30 Participants	15 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	31 participants n=31 Participants	30 participants n=30 Participants	61 participants n=61 Participants
Numeric Pain Rating Scale (NPRS)	5 units on a scale n=31 Participants	5 units on a scale n=30 Participants	5 units on a scale n=61 Participants
Patient Rated Wrist/Hand Evaluation (PRWHE)	47 score on a scale n=31 Participants	48 score on a scale n=30 Participants	48 score on a scale n=61 Participants
Single Assessment Numeric Evaluation (SANE)	70 units on a scale n=31 Participants	65 units on a scale n=30 Participants	65 units on a scale n=61 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Excludes participants with missing data

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").

Outcome measures

Measure	PEMF Device n=25 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=26 Participants 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
Numeric Pain Rating Scale (NPRS)	3 units on a scale Interval 0.0 to 7.0	3 units on a scale Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Excludes participants with missing data

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").

Outcome measures

Measure	PEMF Device n=25 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=25 Participants 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
Numeric Pain Rating Scale (NPRS)	3 units on a scale Interval 1.0 to 6.0	4 units on a scale Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Excludes participants with missing data

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.

Outcome measures

Measure	PEMF Device n=25 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=26 Participants 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
Patient-Rated Wrist/Hand Evaluation (PRWHE)	39 score on a scale Interval 5.0 to 70.0	39 score on a scale Interval 5.0 to 83.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Excludes participants with missing data

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?").

Outcome measures

Measure	PEMF Device n=22 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=22 Participants 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
Single Assessment Numeric Evaluation (SANE)	75 units on a scale Interval 40.0 to 100.0	75 units on a scale Interval 20.0 to 98.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Excludes participants with missing data

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.

Outcome measures

Measure	PEMF Device n=25 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=25 Participants 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
Patient-Rated Wrist/Hand Evaluation (PRWHE)	35 score on a scale Interval 12.0 to 66.0	43 score on a scale Interval 9.0 to 88.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Excludes participants with missing data

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?").

Outcome measures

Measure	PEMF Device n=22 Participants PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=23 Participants 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
Single Assessment Numeric Evaluation (SANE)	73 units on a scale Interval 30.0 to 100.0	65 units on a scale Interval 20.0 to 99.0

Adverse Events

PEMF Device

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham PEMF Device

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PEMF Device n=31 participants at risk PEMF device: PEMF device wear overnight daily for four weeks	Sham PEMF Device n=30 participants at risk 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
Skin and subcutaneous tissue disorders Skin allergy/blistering	9.7% 3/31 • Data collected weekly for 6 weeks	6.7% 2/30 • Data collected weekly for 6 weeks
Musculoskeletal and connective tissue disorders Increased thumb pain	6.5% 2/31 • Data collected weekly for 6 weeks	3.3% 1/30 • Data collected weekly for 6 weeks
Skin and subcutaneous tissue disorders Increased Dupuytren's contracture	0.00% 0/31 • Data collected weekly for 6 weeks	3.3% 1/30 • Data collected weekly for 6 weeks

Additional Information

Dr. Raymond Chou, MD

Stanford University School of Medicine

Phone: 650-723-5256

Email: raymond.chou@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place