Acupuncture for myofascial back pain: imaging and pain outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, blinded study will enroll 64 adults with chronic low back pain from myofascial pain syndrome. Participants receive eight weeks of either true acupuncture or sham acupuncture, with TB-PET/CT imaging and standardized pain and function questionnaires at baseline and after treatment. The study also explores whether metabolic and perfusion changes seen on TB-PET/CT correlate with clinical outcomes. The trial aims to better understand both the clinical efficacy of acupuncture and the potential role of objective imaging biomarkers in myofascial tissue dysfunction. Investigators will compare outcomes between the two arms to determine if imaging can reflect treatment response.

Why it matters

Who can join: the full rules

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

Where it's running

• UC Davis EXPLORER Molecular Imaging Center
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Abhijit J Chaudhari, PhD — University of California, Davis
• Study coordinator: Clinical Research Coordinator Team
• Email: research-radiology-som@health.ucdavis.edu
• Phone: 916-731-9004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.