Trial Outcomes & Findings for The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients (NCT NCT01180244)
NCT ID: NCT01180244
Last Updated: 2014-06-09
Results Overview
Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm\^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of "less pain" sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome).
COMPLETED
NA
91 participants
Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
2014-06-09
Participant Flow
Participant milestones
| Measure |
Active Treatment
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
46
|
|
Overall Study
Received Treatment
|
40
|
45
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Active Treatment
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
7
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
Baseline characteristics by cohort
| Measure |
Active Treatment
n=39 Participants
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
n=38 Participants
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatmentTender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm\^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of "less pain" sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome).
Outcome measures
| Measure |
Active Treatment
n=39 Participants
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
n=38 Participants
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Change in Tender Point Pain Threshold
|
19.6 units on a scale
Standard Deviation 8.4
|
-3.2 units on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatmentThe number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations. A tender point is considered "positive" if less than 4 kilograms per centimeter squared pressure is required to elicit a painful response. The change in number of positive tender points is determined by subtracting the number of positive tender points at baseline from the number of positive tender points at end of treatment. Thus, a negative number represents pain improvement (i.e. better outcome), whereas a positive number represents a worsening of pain (i.e. worse outcome).
Outcome measures
| Measure |
Active Treatment
n=39 Participants
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
n=38 Participants
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Change in Number of Positive Tender Points
|
-7.4 Number of positive tender points
Standard Deviation 4.4
|
-0.2 Number of positive tender points
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatmentPopulation: Participants who correctly completed the outcome questionniare
The Fibromyalgia Impact Questionnaire yields a score ranging from 0 to 100, with higher scores representing a greater impact or level of symptoms. The change in Fibromyalgia Impact Questionnaire is determined by subtracting scores at baseline from scores at end of treatment. Thus negative numbers represent symptom improvement (i.e. a better outcome) and positive numbers represent symptom worsening (i.e. a worse outcome).
Outcome measures
| Measure |
Active Treatment
n=36 Participants
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
n=35 Participants
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Change in Fibromyalgia Impact Questionnaire Overall Score
|
-15.5 units on a scale
Standard Deviation 20.2
|
-5.6 units on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatmentPopulation: Participants who correctly completed the outcome questionniare
The Fibromyalgia Impact Questionnaire includes a pain visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater pain. The change in Fibromyalgia Impact Questionnaire pain visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents pain improvement (i.e. a better outcome), while a positive value represents pain worsening (i.e. a worse outcome).
Outcome measures
| Measure |
Active Treatment
n=36 Participants
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
n=35 Participants
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale
|
-2.0 units on a scale
Standard Deviation 3.0
|
-0.6 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatmentPopulation: Participants who correctly completed the outcome questionnaire
The Fibromyalgia Impact Questionnaire includes a sleep visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater difficulty with sleep. The change in Fibromyalgia Impact Questionnaire sleep visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents sleep improvement (i.e. a better outcome), while a positive value represents sleep worsening (i.e. a worse outcome).
Outcome measures
| Measure |
Active Treatment
n=36 Participants
Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device
Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
|
Placebo Group
n=35 Participants
Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device
Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
|
|---|---|---|
|
Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale
|
-2.1 units on a scale
Standard Deviation 2.5
|
-0.7 units on a scale
Standard Deviation 2.4
|
Adverse Events
Active Treatment
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeffrey B. Hargrove
Department of Mechanical Engineering, Kettering University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place