Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture

University of California Irvine (UCI)

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Procedure: Sham Acupuncture; Procedure: Traditional Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06571110

4736

Details and patient eligibility

About

This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.

Full description

The investigator hypothesizes that traditional acupuncture (TA) enhances binding of the MOR receptor which will then enhance the pain-reducing effects of opioids compared to sham acupuncture (SA). The investigator will test the hypothesis by giving participants a validated Brief Pain Inventory to complete during the pre-therapy opioid challenge and one week after TA or SA therapy is completed.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Traditional acupuncture

Active Comparator group

Description:

During TA, 9 acupuncture needles (Seirin 0.25 · 50 mm) are inserted at GV20,earShenmen,LI4,LI11,SP6,LR3,GB34,and bilateral ST 36. Needle insertion depth is approximately 2 cm for all TA points except for DU 20 and ear Shenmen, which have shallower insertion depths. All needles below the neck level are manually manipulated to elicit De Qi sensations.

Treatment:

Procedure: Traditional Acupuncture

Sham acupuncture

Sham Comparator group

Description:

SA participants experience a non-skin penetrating pricking sensation at 9 non-acupuncture point locations, sham intervention did not penetrate the skin and was designed to not elicit De Qi. somatosensory component generated by this procedure would be likely to be less than the skin penetrating-TA protocol that elicited De Qi. The sham locations were within similar body locations as the TA points; however, the SA location is not on known acupuncture points or meridians.

Treatment:

Procedure: Sham Acupuncture