Trial Outcomes & Findings for Static Magnetic Therapy for Carpal Tunnel Syndrome (NCT NCT02609113)

Results Overview

Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2018-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Strong Magnetic Wristband Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband	Weaker Magnetic Wristband Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband
Overall Study STARTED	11	11
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Static Magnetic Therapy for Carpal Tunnel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Strong Magnetic Wristband n=9 Participants Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband	Weaker Magnetic Wristband n=9 Participants Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband	Total n=18 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 9.60 • n=5 Participants	52 years STANDARD_DEVIATION 6.12 • n=7 Participants	48.7 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.

Outcome measures

Outcome measures
Measure	Strong Magnetic Wristband n=9 Participants Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband	Weaker Magnetic Wristband n=9 Participants Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks	48.6 units on a scale Standard Deviation 6.6	45.4 units on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: The Median Nerve Echogenicity (% hypoechoic) was the same at 89%.

Ultrasound to assess the anatomy of the median nerve

Outcome measures

Outcome measures
Measure	Strong Magnetic Wristband n=9 Participants Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband	Weaker Magnetic Wristband n=9 Participants Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks	89 percentage of hypoechoic	89 percentage of hypoechoic

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Ultrasound to assess the anatomy of the median nerve

Outcome measures

Outcome measures
Measure	Strong Magnetic Wristband n=9 Participants Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband	Weaker Magnetic Wristband n=9 Participants Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks	11.6 mm^2 Standard Deviation 2.8	14.2 mm^2 Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Ultrasound to assess the anatomy of the median nerve

Outcome measures

Outcome measures
Measure	Strong Magnetic Wristband n=9 Participants Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband	Weaker Magnetic Wristband n=9 Participants Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks	33 percentage of Abnormal	33 percentage of Abnormal

Adverse Events

Strong Magnetic Wristband

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weaker Magnetic Wristband

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vanessa Baute, MD

Wake Forest Baptist Health

Phone: 336-716-8140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place