Trial Outcomes & Findings for Transcranial Magnetic Stimulation (TMS) for CRPS (NCT NCT02067273)
NCT ID: NCT02067273
Last Updated: 2017-05-15
Results Overview
Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline, post-treatment, one week follow-up
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
TMS Intervention for 1 Day
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)
|
TMS Intervention for 5 Days
Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
15
|
|
Overall Study
COMPLETED
|
5
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only data from participants who completed the study were analyzed.
Baseline characteristics by cohort
| Measure |
TMS Intervention for 1 Day
n=5 Participants
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)
|
TMS Intervention for 5 Days
n=12 Participants
Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Only data from participants who completed the study were analyzed.
|
0 Participants
n=7 Participants • Only data from participants who completed the study were analyzed.
|
0 Participants
n=5 Participants • Only data from participants who completed the study were analyzed.
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants • Only data from participants who completed the study were analyzed.
|
11 Participants
n=7 Participants • Only data from participants who completed the study were analyzed.
|
15 Participants
n=5 Participants • Only data from participants who completed the study were analyzed.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants • Only data from participants who completed the study were analyzed.
|
1 Participants
n=7 Participants • Only data from participants who completed the study were analyzed.
|
2 Participants
n=5 Participants • Only data from participants who completed the study were analyzed.
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 16.47 • n=5 Participants
|
42.92 years
STANDARD_DEVIATION 13.69 • n=7 Participants
|
44.94 years
STANDARD_DEVIATION 14.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
12 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-treatment, one week follow-upPopulation: Data from participants who completed the study were analyzed.
Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.
Outcome measures
| Measure |
TMS Intervention (1 Day)
n=5 Participants
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)
|
TMS Intervention (5 Days)
n=12 Participants
Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)
|
|---|---|---|
|
Present Pain Intensity
Baseline
|
6.5 Units on a scale
Standard Deviation 2.3
|
6.3 Units on a scale
Standard Deviation 1.4
|
|
Present Pain Intensity
Post-treatment
|
3.1 Units on a scale
Standard Deviation 3.1
|
3.7 Units on a scale
Standard Deviation 3.0
|
|
Present Pain Intensity
One week follow-up
|
4.6 Units on a scale
Standard Deviation 4.0
|
4.3 Units on a scale
Standard Deviation 2.7
|
Adverse Events
TMS Intervention for 1 Day
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TMS Intervention for 5 Days
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TMS Intervention for 1 Day
n=5 participants at risk
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS)
|
TMS Intervention for 5 Days
n=15 participants at risk
Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS)
|
|---|---|---|
|
General disorders
Headache
|
20.0%
1/5 • Number of events 1
|
46.7%
7/15 • Number of events 7
|
|
General disorders
Muscle spasms
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Procedural discomfort
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Increased pain
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Neck pain
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Nausea
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Gingival pain
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
Additional Information
Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Stanford University School of Medicine
Phone: (650) 498-6477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place