Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia

Status Completed

Clinical Trial Summary

This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia.

Clinical Trial Description

Fibromyalgia is one of the most common rheumatic diseases, second only to osteoarthritis. It causes chronic muscle pain and fatigue. Acupuncture functions by targeting specific nerve pathways to different organs or parts of the body. Research has shown that acupuncture is effective in decreasing or eliminating people's sensitivity to pain in targeted regions. However, some believe that the reduction in pain is due to a placebo response rather than acupuncture itself. This study will use two brain-imaging techniques to determine the brain response to acupuncture versus a simulation of acupuncture, thereby assessing whether acupuncture is actually effective in relieving pain.

Participants in this single-blind study will be randomly assigned to receive either acupuncture or a placebo treatment. The placebo will consist of a simulation of acupuncture. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to assess activity of brain mu-opioid receptors. These receptors are involved in the body's ability to perceive pain. All participants will be scanned twice using the fMRI scanner, once before any treatment sessions and once at the conclusion of all treatment sessions. Both fMRI sessions will involve applying pressure to the thumb to elicit a response in the brain in order to assess the corresponding fMRI blood oxygen level dependent (BOLD) signal and whether this activation changes after treatment intervention. Participants will then receive nine treatments of acupuncture or placebo outside the scanner over a 4-week period. The PET portion of this study is optional, and, if you elect to participate, your first treatment session will be performed in the PET scanner. After this first session, participants will have seven additional treatment sessions outside of the scanner over a 4-week period. The last session will be performed in the PET scanner to assess changes in mu-opioid receptor activity that may have occurred over the 4 weeks. A baseline visit to determine eligibility and a close-out visit at week 8 are also part of the participation schedule. It is very important that participants live within driving distance of Ann Arbor, MI due to the significant number of visits to our Center. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00142597
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	May 2005
Completion date	March 2011

View Details

See also
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.