Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07494162
Status
Not Yet Recruiting

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Conditions

  • Chronic Low-back Pain (cLBP)
  • Myofascial Pain Syndrome (MPS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acupuncture — PROCEDURE
    Participants assigned to the acupuncture group will receive standardized acupuncture treatments administered by a licensed acupuncturist. Treatments will occur up to three times per week for eight weeks (maximum of 24 sessions).
  • Sham Acupuncture — PROCEDURE
    Participants assigned to the sham control group will receive sham acupuncture using non-penetrating placebo needles designed to mimic the appearance and sensation of acupuncture without skin penetration. Sessions will occur up to three times per week for eight weeks (maximum of 24 sessions) and will follow procedures similar in duration and setting to the acupuncture intervention.
  • Total-Body PET/CT Imaging — PROCEDURE
    Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging using 18F-fluorodeoxyglucose (18F-FDG). Imaging will be performed at baseline (prior to the first acupuncture/sham acupuncture) and at 8 weeks (after the last acupuncture/sham acupuncture session), with an optional mid-treatment scan at 4 weeks, to evaluate metabolic activity and perfusion in myofascial tissue.

Study Details

This study will evaluate the clinical and biological effects of acupuncture for chronic low back pain associated with myofascial pain syndrome (MPS). In this randomized, participant- and assessor-blinded clinical trial, 64 adults with chronic low back pain due to MPS will be assigned to receive either true acupuncture or sham acupuncture for eight weeks. Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging and complete standardized pain and functional questionnaires at baseline and after treatment. The study will evaluate whether acupuncture improves pain and function compared with sham treatment and whether TB-PET/CT imaging can detect changes in myofascial tissue metabolism and perfusion that correspond with clinical outcomes.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Acupuncture
    Participants randomized to the experimental arm will receive standardized acupuncture treatment up to three sessions per week for eight weeks (maximum of 24 sessions) administered by a licensed acupuncturist.
  • Sham Comparator: Sham Acupuncture
    Participants randomized to the control arm will receive sham acupuncture using non-penetrating needles designed to mimic acupuncture procedures without therapeutic needle penetration.

Primary Outcome Measure

Change in PEG score from Baseline to 8 weeks [ Time Frame: Baseline and 8 weeks post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis EXPLORER Molecular Imaging CenterSacramentoCalifornia95816
Clinical Research Coordinator Team
916-731-9004
Abhijit J Chaudhari, PhD (PRINCIPAL_INVESTIGATOR)

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