Fibromyalgia
Conditions
Brief summary
The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.
Detailed description
Patients and healthy controls will be enrolled in the study for a total of 6 weeks. This includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks), and a follow-up visit and treatment 1 week after completion of the study treatment sessions. To determine the effects of acupuncture on pain, patients and healthy controls will undergo psychophysical pain testing at four points throughout the study: Baseline (appointment 1), post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up session (1 week from last treatment - appointment 10).Participants will also fill out a brief report on pain, sleep, and functioning on a palm pilot. This is expected to take less than 2 minutes per day and will occur throughout the 6 week study period.
Interventions
PROCEDUREAcupuncture
Treatment given twice per week for 4 weeks
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-50 2. Fibromyalgia patient OR healthy control 3. No current opioid use 4. Patients: must have had Fibromyalgia for 6 months or longer
Exclusion criteria
1. Inflammatory disorder (lupus, rheumatoid arthritis) 2. Current untreated depression 3. Active infection 4. Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study 5. Heart disease or use of a cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale | Measured at last study acupuncture session (6 weeks post enrollment) |
Secondary
| Measure | Time frame |
|---|---|
| Change in Fibromyalgia Impact Questionnaire | Change from first to last study treatment session (6 weeks) |
| Change in Brief Pain Inventory | Change from first to last treatment session (6 weeks) |
Countries
United States
Outcome results
None listed