Acupuncture and Pain Processing
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Procedure: Acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acupuncture and Pain Processing |
- Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale [ Time Frame: Measured at last study acupuncture session (6 weeks post enrollment) ] [ Designated as safety issue: No ]
- Change in Fibromyalgia Impact Questionnaire [ Time Frame: Change from first to last study treatment session (6 weeks) ] [ Designated as safety issue: No ]
- Change in Brief Pain Inventory [ Time Frame: Change from first to last treatment session (6 weeks) ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | April 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Acupuncture |
Procedure: Acupuncture
Treatment given twice per week for 4 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18-50
- Fibromyalgia patient OR healthy control
- No current opioid use
- Patients: must have had Fibromyalgia for 6 months or longer
Exclusion Criteria:
- Inflammatory disorder (lupus, rheumatoid arthritis)
- Current untreated depression
- Active infection
- Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study
- Heart disease or use of a cardiac pacemaker
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Sean Mackey | Stanford University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sean Mackey, Assistant Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01270607 History of Changes |
| Other Study ID Numbers: | SU-04132010-5662 |
| Study First Received: | April 14, 2010 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013