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

NCT07494162 | Not Yet Recruiting DMC

• 2 other identifiers: 2344364R33AT012187
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in PEG score from Baseline to 8 weeks

  Change in PEG (Pain intensity, Enjoyment of life, General activity) score from baseline to 8 weeks. The PEG is a 3-item patient-reported outcome measure assessing pain intensity and pain interference with enjoyment of life and general activity. Higher scores indicate worse pain severity and interference. This is the primary clinical endpoint.

  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

  Change in standardized uptake values (SUV) in predefined myofascial regions of interest as measured by total-body positron emission tomography/computed tomography (TB-PET/CT) from baseline to 8 weeks. This is the primary imaging endpoint.

  Baseline and 8 weeks post-intervention

Secondary Outcomes (7)

• Percent Change in PET-Derived K1 Perfusion (mL/min/g) Averaged Across Predefined Myofascial Regions of Interest

  Baseline and 8 weeks post-intervention

• Change in PROMIS Sleep Disturbance Short Form 6a T-Score

  Baseline and 8 weeks post-intervention

• Change in Pain Catastrophizing Scale - Short Form 6 Score

  Baseline and 8 weeks post-intervention

• Patient Global Impression of Change at 8 Weeks

  8 weeks post-intervention

• Change in Patient Health Questionnaire-2 Score

  Baseline and 8 weeks post-intervention

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

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.

Procedure: Acupuncture; Procedure: Total-Body PET/CT Imaging

Sham Acupuncture

SHAM COMPARATOR

Participants randomized to the control arm will receive sham acupuncture using non-penetrating needles designed to mimic acupuncture procedures without therapeutic needle penetration.

Procedure: Sham Acupuncture; Procedure: Total-Body PET/CT Imaging

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).

Acupuncture

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.

Sham Acupuncture

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.

Acupuncture; Sham Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institutes of Health (NIH): collaborator
• University of California, Davis: lead

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Abhijit J Chaudhari, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)