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

NCT02324712 | Withdrawn

• 1 other identifier: 14-0919
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in cytokine IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

  Baseline, 4 weeks

Secondary Outcomes (22)

• Change in patient-reported symptoms on the Measure Yourself Medical Outcome Profile (MYMOP; a 1-page paper questionnaire) after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

  Baseline, 4 weeks

• Change in patient-reported pain intensity on the Pain Scale (a 1-page paper questionnaire) after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

  Baseline, 4 weeks

• Change in cytokine MCP-1 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

  Baseline, 4 weeks

• Change in cytokine IL-1ra levels in circulating blood and saliva after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

  Baseline, 4 weeks

• Change in cytokine IL-2 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1.

  Week 1

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

Acupuncture treatment for TMD

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Acupuncture treatment for TMD using the non-penetrating Park Sham Acupuncture Device

Device: Sham Acupuncture

Interventions

Acupuncture DEVICE

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

Acupuncture

Sham Acupuncture DEVICE

Acupuncture using non-penetrating Park Sham Needles for 20 minutes

Sham Acupuncture

Eligibility Criteria

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

You may qualify if:

• Signed, informed consent; females and males aged 18-64; planning on living in the area for the next 2 months; fluent in written and spoken English;
• Myofascial pain with referral diagnosed according to TMD diagnostic criteria (Schiffman et al. 2014):
• pain in the temporalis and masseter muscles report of familiar pain with palpation of the two muscles report of pain at a site beyond the boundary of the muscle being palpated.

You may not qualify if:

• Traumatic facial injury or surgery on the face or jaw; currently receiving orthodontic treatment;
• Systemic inflammatory disorders such as lupus, kidney failure or renal dialysis, heart disease or heart failure, chronic respiratory disease, hypertension, un- controlled diabetes, epilepsy or seizures
• Hyperthyroidism; chemotherapy or radiation therapy; trigeminal neuralgia; cluster headache;
• Drug or alcohol abuse; active or uncontrolled psychiatric disorders or recent (within 6 months) psychiatric hospitalization; pending pension or worker's claim/litigation; previous experience with acupuncture for TMD
• Current use of NSAIDS and/or steroidal medications.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Related Publications (3)

• Cho SH, Whang WW. Acupuncture for temporomandibular disorders: a systematic review. J Orofac Pain. 2010 Spring;24(2):152-62.

  PMID: 20401353 BACKGROUND

• La Touche R, Goddard G, De-la-Hoz JL, Wang K, Paris-Alemany A, Angulo-Diaz-Parreno S, Mesa J, Hernandez M. Acupuncture in the treatment of pain in temporomandibular disorders: a systematic review and meta-analysis of randomized controlled trials. Clin J Pain. 2010 Jul-Aug;26(6):541-50. doi: 10.1097/AJP.0b013e3181e2697e.

  PMID: 20551730 BACKGROUND

• Slade GD, Conrad MS, Diatchenko L, Rashid NU, Zhong S, Smith S, Rhodes J, Medvedev A, Makarov S, Maixner W, Nackley AG. Cytokine biomarkers and chronic pain: association of genes, transcription, and circulating proteins with temporomandibular disorders and widespread palpation tenderness. Pain. 2011 Dec;152(12):2802-2812. doi: 10.1016/j.pain.2011.09.005. Epub 2011 Oct 14.

  PMID: 22000099 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jongbae (Jay) Park, KMD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Primary Completion: February 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02