Trial Outcomes & Findings for Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS) (NCT NCT02421757)

NCT ID: NCT02421757

Last Updated: 2021-11-23

Results Overview

Immediate relief measured by Numeric Pain Rating Scale (NPRS) Scale from 0-10 0=No pain 10= Worse possible pain

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

60 minutes

Results posted on

2021-11-23

Participant Flow

Recruited at the Pain Management Center at University of Maryland Rehabilitation \& Orthopaedic Institute from 8/22/2016-4/27/2017.

Patients who agreed to participate were provided with a pain diary and were instructed to document their average pain each day for a week using the Numeric Pain Rating Scale (NPRS) to establish their baseline level of pain. Patients were also given the Global Pain Scale (GPS) to complete and return on the day of treatment.

Participant milestones

Participant milestones
Measure	Transcutaneous Magnetic Stimulation Transcutaneous Magnetic Stimulation Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation	Sham Device Sham Device Placebo: The placebo Transcutaneous device
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcutaneous Magnetic Stimulation n=11 Participants Transcutaneous Magnetic Stimulation Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation	Sham Device n=9 Participants Sham Device Placebo: The placebo Transcutaneous device	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Immediate relief measured by Numeric Pain Rating Scale (NPRS) Scale from 0-10 0=No pain 10= Worse possible pain

Outcome measures

Outcome measures
Measure	Transcutaneous Magnetic Stimulation n=11 Participants Transcutaneous Magnetic Stimulation Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation	Sham Device n=9 Participants Sham Device Placebo: The placebo Transcutaneous device
Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)	4.89 score on a scale Interval 0.0 to 10.0	5.18 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 30 days

Durable pain relief measured by Numeric Pain Rating Scale (NPRS) 0= No pain 10= Worse imaginable pain

Outcome measures

Outcome measures
Measure	Transcutaneous Magnetic Stimulation n=11 Participants Transcutaneous Magnetic Stimulation Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device: Transcutaneous Magnetic Stimulation	Sham Device n=9 Participants Sham Device Placebo: The placebo Transcutaneous device
Durable Pain Measured by Numeric Pain Rating Scale (NPRS)	6.00 score on a scale Interval 0.0 to 10.0	6.57 score on a scale Interval 0.0 to 10.0

Adverse Events

Transcutaneous Magnetic Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Device

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

Dr. Peter Rock

University of Maryland School of Medicine

Phone: 410-328-6933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place