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Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD

NCT02324712 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-02-23

No results posted yet for this study

Summary

Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines and growth factors in the circulating blood (and cytokine levels only in saliva) of patients with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine differences in cytokine profiles between real and sham acupuncture in circulating blood of patients with chronic TMD; and 3) To explore correlations between these changes and clinical outcomes.

Participants: Patients with chronic TMD pain recruited through the University of North Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic.

Procedures (methods): Participants will complete a self-administered questionnaire assessing TMD-related comorbidity. During the initial visit, study examiners will record clinical characteristics of muscles and joints of the head, neck and body according to newly recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index (computed from numeric rating scales) of masseter, temporalis and the supplemental painful muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile; MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and after acupuncture treatments. Participants will self-collect pre-treatment and post-treatment saliva samples. Patients will receive 4 acupuncture treatments, once per week for 4 weeks. The primary outcome measure is change in IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with sham acupuncture. Secondary outcome measures include comparing changes in levels of nerve growth factor (NGF), tumor necrosis factor-alpha (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10, before and after real acupuncture at Week 1 compared with sham acupuncture and before and after real acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome measure is correlation between changes in cytokine levels and clinical variables after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

Conditions

  • Temporomandibular Joint Disorders

Interventions

DEVICE

Acupuncture

Acupuncture using standard stainless steel acupuncture needles inserted into intramuscular tissue for 20 minutes

DEVICE

Sham Acupuncture

Acupuncture using non-penetrating Park Sham Needles for 20 minutes

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jongbae (Jay) Park, KMD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02324712 on ClinicalTrials.gov