Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryParticipants 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
Procedure/SurgeryParticipants 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
Procedure/SurgeryParticipants 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: AcupunctureActive comparator 2 interventions
Group B: Sham AcupunctureSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 8 weeks post-intervention2
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.
Time frame
Baseline and 8 weeks post-interventionSecondary outcomes
1
Percent Change in PET-Derived K1 Perfusion (mL/min/g) Averaged Across Predefined Myofascial Regions of Interest
K1 perfusion parameter (mL/min/g), representing tracer delivery and tissue blood flow, will be quantified using total-body PET/CT in predefined myofascial regions of interest (ROIs). For each participant, K1 values will be calculated for each ROI and averaged across all predefined ROIs to generate a single summary value per timepoint. The outcome measure is the percent change in mean K1 from baseline to 8 weeks post-intervention.
Time frame
Baseline and 8 weeks post-intervention2
Change in PROMIS Sleep Disturbance Short Form 6a T-Score
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance Short Form 6a will be used to assess sleep disturbance. Responses are converted to a standardized T-score (range 0-100), where higher scores indicate greater sleep disturbance. The outcome measure is the change in T-score from baseline to 8 weeks post-intervention.
Time frame
Baseline and 8 weeks post-intervention3
Change in Pain Catastrophizing Scale - Short Form 6 Score
Change in Pain Catastrophizing Scale Short Form 6 score from baseline to 8 weeks. Scores range from 0-24 with higher scores indicating greater pain catastrophizing.
Time frame
Baseline and 8 weeks post-intervention4
Patient Global Impression of Change at 8 Weeks
Participant-reported Patient Global Impression of Change (PGIC) at 8 weeks following treatment. Scores range from 1 to 7, with higher scores indicating worsening.
Time frame
8 weeks post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov