Ignite Creation Date:
2024-05-06 @ 3:35 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02324712
Status:
WITHDRAWN
Last Update Posted:
2016-02-23
First Post:
2014-12-19
Brief Title:
Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD
Status:
WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI relocated to another institution study may be resubmitted at a later date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TNFαvascular 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
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 TNFαvascular 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
Detailed Description:
Temporomandibular disorder TMD is known to be the second most frequent musculoskeletal pain condition following low back pain According to the NIDCR TMD affects 5-12 of the population at an annual cost estimated at 4 billion dollars in the US Recent studies that have investigated acupuncture as a treatment for musculoskeletal pain have reported various results Several meta-analyses and systematic reviews of randomized controlled trials suggest that acupuncture treatment improves TMD-related pain Its mechanism of action in improving TMD pain however is largely unclear
Elevated levels of pro-inflammatory cytokines eg MCP-1 and IL-8 have been found in circulating blood of patients with TMD Upregulated pro-inflammatory cytokine levels have been correlated with greater sensitivity to pain evoking stimuli Abnormalities in levels of pro-inflammatory cytokines are often accompanied by alterations in levels of anti-inflammatory cytokines eg IL-1ra which are associated with reductions in pain and inflammation The effects of acupuncture on pro- and anti-inflammatory cytokines growth factors and clinical pain and function have not been reported in a prospective cohort of TMD patients at multiple time points in the clinical setting The proposed mechanistic study seeks to ascertain if acupuncture compared to sham acupuncture produces measurable changes in circulating pro- and anti-inflammatory cytokines and growth factors in a manner that is associated with patient self-reports of pain and function over a 4-week treatment period Cytokine and growth factor levels will be measured in blood and saliva saliva will be used to measure cytokine levels only
Elevated levels of pro-inflammatory cytokines eg MCP-1 and IL-8 have been found in circulating blood of patients with TMD Upregulated pro-inflammatory cytokine levels have been correlated with greater sensitivity to pain evoking stimuli Abnormalities in levels of pro-inflammatory cytokines are often accompanied by alterations in levels of anti-inflammatory cytokines eg IL-1ra which are associated with reductions in pain and inflammation The effects of acupuncture on pro- and anti-inflammatory cytokines growth factors and clinical pain and function have not been reported in a prospective cohort of TMD patients at multiple time points in the clinical setting The proposed mechanistic study seeks to ascertain if acupuncture compared to sham acupuncture produces measurable changes in circulating pro- and anti-inflammatory cytokines and growth factors in a manner that is associated with patient self-reports of pain and function over a 4-week treatment period Cytokine and growth factor levels will be measured in blood and saliva saliva will be used to measure cytokine levels only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None