Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD
Từ khóa
trừu tượng
Sự miêu tả
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, e.g., 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, e.g., 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.
ngày
| Xác minh lần cuối: | 01/31/2016 |
| Đệ trình đầu tiên: | 12/18/2014 |
| Đăng ký ước tính đã được gửi: | 12/18/2014 |
| Đăng lần đầu: | 12/23/2014 |
| Cập nhật lần cuối được gửi: | 02/21/2016 |
| Cập nhật lần cuối đã đăng: | 02/22/2016 |
| Ngày hoàn thành chính ước tính: | 01/31/2016 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Device: Acupuncture
Device: Sham Acupuncture
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Active Comparator: Acupuncture Acupuncture treatment for TMD | Device: Acupuncture Acupuncture using standard stainless steel acupuncture needles inserted into intramuscular tissue for 20 minutes |
| Sham Comparator: Sham Acupuncture Acupuncture treatment for TMD using the non-penetrating Park Sham Acupuncture Device | Device: Sham Acupuncture Acupuncture using non-penetrating Park Sham Needles for 20 minutes |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
| Giới tính đủ điều kiện để nghiên cứu | All |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Kết quả
Các biện pháp kết quả chính
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]
Các biện pháp kết quả thứ cấp
1. 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]
2. 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]
3. 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]
4. 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]
5. 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]
6. Change in cytokine IL-4 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
7. Change in cytokine IL-6 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
8. Change in cytokine IL-10 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
9. Change in cytokine IL-2 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
10. Change in cytokine IL-4 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
11. Change in cytokine IL-6 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
12. Change in cytokine IL-10 levels in circulating blood and saliva prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
13. Change in nerve growth factor (NGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
14. Change in vascular endothelial growth factor (VEGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
15. Change in platelet-derived growth factor (PDGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
16. Change in basic fibroblast growth factor (bFGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
17. Change in tumor necrosis factor alpha (TNFa) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 1. [Week 1]
18. Change in nerve growth factor (NGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
19. Change in vascular endothelial growth factor (VEGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
20. Change in platelet-derived growth factor (PDGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
21. Change in basic fibroblast growth factor (bFGF) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
22. Change in tumor necrosis factor alpha (TNFa) levels in circulating blood prior to and after real acupuncture compared with sham acupuncture at study Week 4. [Week 4]
