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Recruiting
NCT07494162
Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome
Conditions: Myofascial Pain Syndrome (MPS), Chronic Low-back Pain (cLBP)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: University of California, Davis
Location: UC Davis EXPLORER Molecular Imaging Center Sacramento California
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.
Eligibility Criteria
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\
Source: ClinicalTrials.gov (NCT07494162). StuddyBuddy aggregates publicly available trial information.