Effect of Traditional Acupuncture Compared to Sham Acupuncture on Opioid Pain Relief in Adults with Fibromyalgia
Led by University of California, Irvine · Updated on 2026-06-15
45
Participants Needed
1
Research Sites
34 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether traditional acupuncture can improve pain relief from opioids in people with fibromyalgia who already use these pain medications. The study compares traditional acupuncture to sham acupuncture, which mimics the procedure without actual needle insertion or stimulation, to see if acupuncture enhances the opioid effect on pain reduction. Participants complete a pain questionnaire before and after acupuncture treatments to assess changes.
Participants receive either traditional acupuncture, where thin needles are inserted at specific points on the body and manually manipulated to create a sensation called De Qi, or sham acupuncture, which involves non-penetrating pricking sensations at non-acupuncture points. The treatments are given in a controlled, randomized, and double-blind manner to fairly compare the effects over about two weeks.
During the study, participants complete the Brief Pain Inventory and visual pain scales before starting opioid challenges and again one week after completing the acupuncture therapies. Researchers measure changes in pain scores over time to evaluate the impact of the treatments. The study includes adults aged 18 to 80 with fibromyalgia who are on continuous opioid therapy and experience moderate to severe baseline pain. Safety and supportive care continue throughout the study period.
CONDITIONS
Brief Title
Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
Research Team
S
Shima Khanahmadi, MD
H
Hannah Cho, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Traditional acupuncture
Sham acupuncture
What is it?
Traditional acupuncture involves inserting fine needles into specific points on the body, with the goal of relieving pain and altering pain pathways.
Sham acupuncture uses superficial needle insertion at non-therapeutic sites without stimulation. It is designed to mimic the acupuncture experience but is not intended to have therapeutic effects.
Role in trial
Active trial arm. Traditional acupuncture is evaluated for its capacity to improve analgesic response to opioids in patients with fibromyalgia.
Control arm. Used to separate the true effects of acupuncture from placebo and procedural effects in opioid-using fibromyalgia patients.
Primary use in fibromyalgia
Investigated for supporting pain control and assessing changes in opioid-induced analgesia among people with chronic fibromyalgia pain.
Serves as an inert comparison to determine whether observed changes in pain or opioid response are due to the active acupuncture technique or to participant expectation or procedural effects.
How is it given?
Performed by inserting fine needles at specific body points, with techniques and stimulation as per traditional acupuncture practice.
Performed by superficially placing needles at non-acupuncture points without active stimulation, intended to control for procedural aspects.
Evidence status in fibromyalgia
Multiple randomized trials demonstrate that traditional acupuncture can reduce pain and improve symptoms in some people with fibromyalgia compared to sham acupuncture. Responses vary, and neuroimaging evidence suggests distinct biological effects.
Sham acupuncture often produces significant placebo responses in fibromyalgia but does not show the same neurobiological effects or magnitude of pain relief as traditional acupuncture in most studies.
Important limitations
The exact mechanisms for analgesia are not fully established. Not all patients respond, and effects can depend on individual pain sensitivity and expectations. Benefits may be moderate and require regular sessions.
Sham acupuncture is intended as a placebo but can yield meaningful pain relief due to nonspecific effects. It is not a clinical therapy and its benefits may largely reflect placebo responses.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
Are 18 - 80 years old
Have been diagnosed with Fibromyalgia for more than 6 months
Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily
Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)
You will not qualify if you...
Are younger than 18 or older than 80 years old
Have been diagnosed with a Substance Use Disorder (SUD)
Pregnant
Have an active litigation or worker's compensation case
Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation
Are prescribed and actively using low dose Naltrexone
Have tried acupuncture in the last 6 months
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 weeks
Participants receive either traditional acupuncture with needle insertion at specific points or sham acupuncture that mimics the procedure without skin penetration.
Multiple visits during treatment period
Follow-up
Duration - 1 week
Participants complete pain assessments one week after finishing acupuncture treatments to evaluate changes in pain scores.
1 visit (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Pressure Pain Sensitivity and Insular Combined Glutamate and Glutamine (Glx) Are Associated with Subsequent Clinical Response to Sham But Not Traditional Acupuncture in Patients Who Have Chronic Pain.