Trial Outcomes & Findings for Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain (NCT NCT02064296)
NCT ID: NCT02064296
Last Updated: 2022-09-22
Results Overview
Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM, as shown by the difference in brain connectivity between healthy controls and FM patients as measured by FMRI (occurrence rate of co-activation pattern). For each arm, the coactivation pattern was assessed at rest and during a pressure pain stimulation. This is measured by the percent of scan time that an individual's brain displayed a particular coactivation pattern related to the somatosensory system.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
At baseline
Results posted on
2022-09-22
Participant Flow
15 FM Participants were consented and eligible for the study but withdrew prior to being randomized to treatment.
Participant milestones
| Measure |
Controls
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Mock Laser Acupuncture
39 fibromyalgia (FM) patients were randomized to control mock laser acupuncture (Vita Laser 650, Lhasa OMS). They received 2 treatments per week for 4 weeks. As consented, they were told, with IRB permission, that they were receiving laser acupuncture. This deception was essential to maintaining scientific integrity of the masking.
Laser acupuncture (Non-traditional Acupuncture): For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions. There was no palpation prior to positioning these devices, and there was no physical contact between device and skin.
|
Electro-Acupuncture
40 fibromyalgia patients were randomized to receive electro-acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co). They received 2 treatments per week for 4 weeks.
Needle acupuncture (Traditional Acupuncture): This group received needle acupuncture at 3 pairs of sites. The needles were stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).
|
|---|---|---|---|
|
Eligibility to Baseline Data Collection
STARTED
|
27
|
39
|
40
|
|
Eligibility to Baseline Data Collection
COMPLETED
|
26
|
39
|
40
|
|
Eligibility to Baseline Data Collection
NOT COMPLETED
|
1
|
0
|
0
|
|
Baseline Data Collection
STARTED
|
26
|
39
|
40
|
|
Baseline Data Collection
COMPLETED
|
26
|
39
|
40
|
|
Baseline Data Collection
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention
STARTED
|
0
|
39
|
40
|
|
Intervention
COMPLETED
|
0
|
38
|
38
|
|
Intervention
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Controls
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Mock Laser Acupuncture
39 fibromyalgia (FM) patients were randomized to control mock laser acupuncture (Vita Laser 650, Lhasa OMS). They received 2 treatments per week for 4 weeks. As consented, they were told, with IRB permission, that they were receiving laser acupuncture. This deception was essential to maintaining scientific integrity of the masking.
Laser acupuncture (Non-traditional Acupuncture): For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions. There was no palpation prior to positioning these devices, and there was no physical contact between device and skin.
|
Electro-Acupuncture
40 fibromyalgia patients were randomized to receive electro-acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co). They received 2 treatments per week for 4 weeks.
Needle acupuncture (Traditional Acupuncture): This group received needle acupuncture at 3 pairs of sites. The needles were stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).
|
|---|---|---|---|
|
Eligibility to Baseline Data Collection
Withdrawal by Subject
|
1
|
0
|
0
|
|
Intervention
Withdrawal by Subject
|
0
|
1
|
2
|
Baseline Characteristics
Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
Baseline characteristics by cohort
| Measure |
Controls
n=26 Participants
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Non-Traditional (Mock) Acupuncture
n=38 Participants
39 fibromyalgia patients were randomized to non-traditional laser acupuncture (Vita Laser 650, Lhasa OMS).
They received 2 treatments per week for 4 weeks. As consented, they were told, with IRB permission, that they were receiving laser acupuncture. This deception was essential to maintaining scientific integrity of the masking.
Laser acupuncture (Non-traditional Acupuncture): For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions. There was no palpation prior to positioning these devices, and there was no physical contact between device and skin.
|
Traditional Acupuncture
n=38 Participants
40 fibromyalgia patients were randomized to receive electro-acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co). They received 2 treatments per week for 4 weeks.
Needle acupuncture (Traditional Acupuncture): This group received needle acupuncture at 3 pairs of sites. The needles were stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 14.542881 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 9.865814 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 12.40337 • n=5 Participants
|
43 years
STANDARD_DEVIATION 12.203111 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: Because this is at baseline (pre-treatment) all fibromyalgia patients are combined in a single analysis group. Some individuals' data was unable to be analyzed because of typical collection challenges (e.g. participant movement). Three participants were lost to follow-up. Four fibromyalgia patients were excluded due to: pain from shingles (N=1), starting Adderall treatment (N=1), inadequate treatments (N=1), and doubling pregabalin dosage (N=1), taking place during the study.
Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM, as shown by the difference in brain connectivity between healthy controls and FM patients as measured by FMRI (occurrence rate of co-activation pattern). For each arm, the coactivation pattern was assessed at rest and during a pressure pain stimulation. This is measured by the percent of scan time that an individual's brain displayed a particular coactivation pattern related to the somatosensory system.
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Fibromyalgia Patients
n=63 Participants
All fibromyalgia patients measured at baseline (regardless of randomization).
|
|---|---|---|
|
Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
Sensorimotor co-activation pattern at rest
|
0.1281 percentage of scan time
Standard Deviation 0.05229
|
0.1190 percentage of scan time
Standard Deviation 0.03835
|
|
Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
Salience network co-activation pattern at rest
|
0.1213 percentage of scan time
Standard Deviation 0.05289
|
0.1345 percentage of scan time
Standard Deviation 0.04560
|
|
Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
Sensorimotor co-activation pattern at pressure pain
|
0.1328 percentage of scan time
Standard Deviation 0.05213
|
0.1362 percentage of scan time
Standard Deviation 0.03972
|
|
Brain Neurocircuitry Underlying Chronic Pain (Percent of Time of a Somato-sensory Cortex Coactivation Pattern)
Salience network co-activation pattern at pressure pain
|
0.1121 percentage of scan time
Standard Deviation 0.05065
|
0.1054 percentage of scan time
Standard Deviation 0.04662
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Of the 38 participants in each arm who completed the intervention, three participants from the traditional acupuncture arm and one from the mock laser acupuncture arm were excluded from analysis for reasons complicating treatment interpretation, (e.g. addition of a new pain symptom or addition of an external study treatment.) Three participants from the Traditional Acupuncture arm were excluded due to poor data quality at either the pre- or post-treatment scanning visit.
Brain connectivity will be assessed at baseline and following either electro-acupuncture or mock laser acupuncture. Primary somatosensory cortex to insula connectivity. (Z-stat) A positive Z score reflects positive correlation in FMRI signal between different between brain areas. A negative Z score represents anti-correlation between in FMRI signal between brain regions. These scores reflect either positive connectivity or inhibitory connectivity. A mean of 0 represents no correlation or connectivity between regions.
Outcome measures
| Measure |
Healthy Controls
n=37 Participants
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Fibromyalgia Patients
n=32 Participants
All fibromyalgia patients measured at baseline (regardless of randomization).
|
|---|---|---|
|
Change in Brain Connectivity With Acupuncture Treatment
Baseline
|
0.5492 Z - stat
Standard Deviation 1.799
|
-0.3013 Z - stat
Standard Deviation 1.178
|
|
Change in Brain Connectivity With Acupuncture Treatment
Post-treatment (4 weeks)
|
-0.08589 Z - stat
Standard Deviation 1.182
|
1.125 Z - stat
Standard Deviation 1.379
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Sixteen of the thirty-nine Non-Traditional Acupuncture treatment participants were excluded either for missing data or poor data quality while twenty-one of the forty Traditional Acupuncture treatment participants were excluded for missing data or poor data quality.
Brain neurochemistry assessed at baseline and following either electro-acupuncture or mock laser acupuncture using proton magnetic resonance spectroscopy (1H-MRS) measures of combined glutamate and glutamine (Glx).
Outcome measures
| Measure |
Healthy Controls
n=23 Participants
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Fibromyalgia Patients
n=19 Participants
All fibromyalgia patients measured at baseline (regardless of randomization).
|
|---|---|---|
|
Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment
Glx at baseline
|
11.91 AIU (arbitrary institutional units)
Standard Deviation 1.005
|
12.11 AIU (arbitrary institutional units)
Standard Deviation 1.940
|
|
Change in Brain Neurochemistry of Combined Glutamate and Glutamine (Glx) Within the Anterior Insular Cortex With Acupuncture Treatment
Glx at 4 weeks
|
11.82 AIU (arbitrary institutional units)
Standard Deviation 1.042
|
11.88 AIU (arbitrary institutional units)
Standard Deviation 1.572
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Fourteen of the thirty-nine Non-Traditional Acupuncture treatment participants were excluded either for missing data or poor data quality while twenty-two of the forty Traditional Acupuncture treatment participants were excluded for missing data or poor data quality.
Brain neurochemistry assessed at baseline and following either electro-acupuncture or mock laser acupuncture using proton magnetic resonance spectroscopy (1H-MRS) measures gama-aminobutyric acid (GABA).
Outcome measures
| Measure |
Healthy Controls
n=25 Participants
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Fibromyalgia Patients
n=18 Participants
All fibromyalgia patients measured at baseline (regardless of randomization).
|
|---|---|---|
|
Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment
GABA at baseline
|
3.250 AIU (arbitrary institutional units)
Standard Deviation 0.9074
|
3.264 AIU (arbitrary institutional units)
Standard Deviation 0.4840
|
|
Change in Brain Neurochemistry of Gama-aminobutyric Acid (GABA) Within the Anterior Insular Cortex With Acupuncture Treatment
GABA at 4 weeks
|
3.135 AIU (arbitrary institutional units)
Standard Deviation 0.6650
|
3.210 AIU (arbitrary institutional units)
Standard Deviation 0.8271
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineBaseline neuroimaging outcomes of neurochemistry are used to predict subsequent response to electro-acupuncture and laser acupuncture.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineBaseline neuroimaging outcomes of connectivity are used to predict subsequent response to electroacupuncture and laser acupuncture.
Outcome measures
Outcome data not reported
Adverse Events
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Traditional (Mock) Acupuncture
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Traditional Acupuncture
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Controls
n=27 participants at risk
Healthy pain free controls were recruited for comparison with fibromyalgia patients.
|
Non-Traditional (Mock) Acupuncture
n=39 participants at risk
39 fibromyalgia (FM) patients were randomized to control mock laser acupuncture (Vita Laser 650, Lhasa OMS). They received 2 treatments per week for 4 weeks. As consented, they were told, with IRB permission, that they were receiving laser acupuncture. This deception was essential to maintaining scientific integrity of the masking.
Laser acupuncture (Non-traditional Acupuncture): For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) was positioned over all of the same acupoints used in electro-acupuncture (EA), but was turned off during treatment sessions. There was no palpation prior to positioning these devices, and there was no physical contact between device and skin.
|
Traditional Acupuncture
n=40 participants at risk
40 fibromyalgia patients were randomized to receive electro-acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co). They received 2 treatments per week for 4 weeks.
Needle acupuncture (Traditional Acupuncture): This group received needle acupuncture at 3 pairs of sites. The needles were stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
10.3%
4/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
7.5%
3/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Vascular disorders
Bruising
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
0.00%
0/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
12.5%
5/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Psychiatric disorders
Pain Attack
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
0.00%
0/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.0%
2/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.1%
2/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.0%
2/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Nervous system disorders
Migraine
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
0.00%
0/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
7.5%
3/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Musculoskeletal and connective tissue disorders
Ear Tenderness
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
0.00%
0/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.0%
2/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia Flare
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
7.7%
3/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.0%
2/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramp
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
0.00%
0/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.0%
2/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Burning
|
0.00%
0/27 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
0.00%
0/39 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
5.0%
2/40 • AE data for healthy volunteers was collected for visits 2 through 3, which were both within 3 days of each other, up to 4 days total. No further AE data was collected for the healthy volunteers. For fibromyalgia participants, in both treatment arms, AE data was collected at every visit, covering a period of at least 6 weeks and then for up to another 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place