Fibromyalgia Clinical Trial
Official title:
A Randomized, Double-blind,Placebo-controlled, Two-way Crossover Study to Evaluate the Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging Activation Patterns in Patients With Fibromyalgia
Verified date | October 2017 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue. Researchers want to find out if "a drug" called milnacipran can help people with fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of fibromyalgia. In this study, milnacipran will be given to find out more about how it affects pain and thinking in people with fibromyalgia.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - You may be eligible to take part in this study if the following are true: - You are between the age of 18 and 70 years - If you are female - If you are right handed - You have a diagnosis of fibromyalgia for at least 3 months, as defined by the American College of Rheumatology 1990 Criteria - You are willing to stop taking certain medicines that you may be taking on a regular basis. The researchers will discuss these medications with you in detail Exclusion Criteria: - You may not be eligible take part in this study if any of the following are true for you: - You have problems with your heart or cardiovascular system - You have problems with your liver or kidneys - You have an autoimmune disease, or a whole-body infection like HIV or hepatitis - You have cancer - You are pregnant or breastfeeding - You abuse drugs or alcohol - You have suicidal thoughts or wishes - You have taken milnacipran or another study drug within the last 30 days - You have a medical problem not listed here that would make it unsafe for you to take part in the study - The research team feels that you will be unable to complete all phases of the study |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan, Chronic Pain and Fatigue Research Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment | Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later | ||
Other | Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns) | Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later | ||
Other | Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment. | Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later | ||
Primary | Pain Threshold at Baseline | The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm^2. | Baselines measured at week 0 and week 9 after washout from first assignment to treatment | |
Primary | Change in Pain Threshold From Baseline to End of Treatment. | The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome. | baseline compared with 6 weeks of treatment | |
Secondary | Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline. | 0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome. | Baselines measured at week 0 and week 9 after washout from first assignment to treatment | |
Secondary | Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment. | 0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome. | baseline compared with 6 weeks of treatment | |
Secondary | Pain Tolerance at Baseline | The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline. | Baselines measured at week 0 and week 9 after washout from first assignment to treatment | |
Secondary | Change in Pain Tolerance From Baseline to End of Treatment | The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome. | baseline compared wtih 6 weeks of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A |