NCT07494162

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

IMPACT-MPS: Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Myofascial pain syndrome (MPS) is a musculoskeletal pain disorder characterized by localized muscle pain, trigger points, and functional limitations. MPS is frequently associated with chronic low back pain and contributes substantially to reduced quality of life and increased healthcare utilization. Despite its prevalence, diagnosis and treatment monitoring rely largely on subjective clinical examination and patient-reported outcomes because validated objective biomarkers of myofascial tissue dysfunction are lacking. Acupuncture is widely used as a non-pharmacologic treatment for chronic pain and has demonstrated benefit in several chronic low back pain studies. However, the biological mechanisms underlying acupuncture's therapeutic effects remain poorly understood, in part because objective measures of tissue-level response are limited. Total-body positron emission tomography/computed tomography (TB-PET/CT) is a highly sensitive molecular imaging technique capable of assessing metabolic activity and blood flow throughout the body. Recent observational work using TB-PET/CT has demonstrated the ability to differentiate painful myofascial tissue from non-painful tissue, suggesting that this technology may provide quantitative biomarkers of myofascial dysfunction. The IMPACT-MPS study is a two-arm, randomized, participant- and assessor-blinded, sham-controlled clinical trial designed to evaluate both the clinical efficacy of acupuncture and the utility of TB-PET/CT imaging biomarkers in MPS. A total of 64 adults with chronic low back pain associated with myofascial pain syndrome will be enrolled and randomized in a 1:1 ratio to receive either standardized acupuncture treatment or sham acupuncture. Participants will receive up to three acupuncture or sham sessions per week for eight weeks. TB-PET/CT imaging and patient-reported outcome assessments will be performed at baseline and at 8 weeks, with an optional imaging and assessment visit at week 4. Clinical outcomes will include standardized pain and function measures, including the PEG (Pain intensity, Enjoyment of life, General activity) scale and other NIH HEAL Common Data Elements. The primary clinical endpoint is the change in PEG score from baseline to 8 weeks. The primary imaging endpoint is the change in standardized uptake values in predefined myofascial regions of interest measured by TB-PET/CT. Secondary outcomes include additional patient-reported outcomes and imaging measures of myofascial tissue metabolism and perfusion. This study aims to determine whether acupuncture improves clinical outcomes in patients with myofascial pain syndrome and to evaluate TB-PET/CT as an objective imaging biomarker of myofascial tissue dysfunction and treatment response. The results may support the development of imaging-based tools for evaluating chronic musculoskeletal pain and monitoring treatment effects.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-04-01
• Completion: 2030-04-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States