Recruiting

Acupuncture

Sponsor:

UCLA

Code:

NCT07494162

Conditions

Myofascial Pain Syndrome (MPS)

Chronic Low-back Pain (cLBP)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Sham Acupuncture

Total-Body PET/CT Imaging

Study Details

Brief summary:

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.

Conditions

Myofascial Pain Syndrome (MPS)

Chronic Low-back Pain (cLBP)

Study ID

NCT07494162

Start date

May 18, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to understand the purposes and risks of the trial and willingness to sign an informed consent form
  • Willingness and ability to comply with all protocol required procedures
  • Willingness to be randomized to receive either true acupuncture or sham acupuncture
  • Current self-report of chronic low back pain (cLBP) which has persisted for the past 3 months AND has resulted in pain on > 50% of days in the past 6 months
  • At least one palpable nodule or taut band in paraspinal, quadratus lumborum, or gluteal muscles
  • Reproduction of the patient's dominant pain with palpation of a muscle nodule or taut band
  • Predominantly paramedian pain (may be uni-lateral or bi-lateral)
  • Willing and able to lay motionless in a supine position at least twice, preferably thrice: 70-minute TB-PET/CT scan
  • Willing and able to fast for at least 6 hours before and for the duration of the TB-PET/CT scan
  • Willing to avoid strenuous exercise for 24 hours before the TB-PET/CT scan visit
  • Willingness to practice effective contraception during the study.

Exclusion Criteria:

  • No Primary Care Physician
  • History of spine infection (discitis or osteomyelitis) or spine tumor
  • History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
  • Confounding conditions that are known to be responsible for inducing pain
  • Implants at or in the region of the sites of interest
  • Diagnosis of any vertebral fracture in the last 6 months
  • Cauda equina syndrome or lumbar radiculopathy with functional motor deficit (strength<4/5 on manual motor testing)
  • Spinal implants (including fixation hardware, spinal cord stimulator, intra-thecal pumps, that are present in the region of the sites of interest)
  • Predominantly central pain
  • Pain below the knee
  • Positive straight leg raise test
  • Symptomatic hip arthritis
  • Uncontrolled claustrophobia
  • Pregnant or lactating participants
  • Body weight more than 225 kg (496 pounds) due to the weight limitation of the scanner bed
  • Prisoners
  • Inability to speak, read, and write in the English language
  • Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.

That is, PET scans are not performed as part of a patient's treatment plan (e.g. standard of care, therapeutic purposes, or clinical care) and the research study did not intend to provide therapeutic benefit to the patient.

•Any other criteria, which would make the participant unsuitable to participate in this study as determined by the Principal Investigator

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Acupuncture

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

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

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.

Primary outcome measure

  • Change in PEG score from Baseline to 8 weeks [ Time Frame: Baseline and 8 weeks post-intervention ]
  • Change in Standardized Uptake Values in Myofascial Regions of Interest on TB-PET/CT from Baseline to 8 weeks [ Time Frame: Baseline and 8 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator Team

916-731-9004research-radiology-som@health.ucdavis.edu

Locations

UC Davis EXPLORER Molecular Imaging Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Clinical Research Coordinator Team

916-731-9004Research-radiology-som@health.ucdavis.edu

Principal Investigator:

Abhijit J Chaudhari, PhD

More Information

Sponsor

University of California, Davis

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • acupuncture treatment
  • Total-Body PET
  • FDG PET
  • Myofascial Pain Syndrome
  • Chronic Low Back Pain
  • Imaging Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-06-17.