Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.
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Sự miêu tả
Temporomandibular Disorders (TMDs) are a subgroup of painful orofacial disorders of the stomatognathic system, characterized by TemporoMandibular Joint (TMJ) pain, fatigue of the cranio-cervico-facial muscles (especially the masticatory muscles), limitation of mandibular movement and the presence of a click or crackling sound in the ATM.
The main signs and symptoms associated with TMDs are bruxism (33%), myofascial pain (14%), headache (96%) and functional limitation (93%), the latter being related to posture.
The quality of life of patients with TMD involvement is diminished in various facets of their lives, leading to a private expense for the patient as well as a public expense resulting from a poor referral due to the lack of adequate treatment for TMDs. This expense ranges in Spanish public hospitals at € 146.9 with a minimum of € 52 and a maximum of € 425.
From this study, we are going to carry out a non-invasive, analgesic, anti-inflammatory treatment and without negative side effects for the patient through radial extracorporeal shock waves (rESWT), and manual therapy (TM).
Among the effects produced by shock waves we find that they improve circulation due to increased blood flow and oxygenation, at tissue level the permeability of the membrane increases and its metabolic process, therefore facilitating the activation of tissue regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle relaxation.
The main objective of the study is to evaluate the capacity of the shock waves to improve the alterations due to temporomandibular disorders. To meet the above objective, a single-blind randomized clinical trial study has been designed. The selected subjects will be of legal age diagnosed with temporomandibular disorder and those subjects that due to their own characteristics are not able to carry out the study will be excluded. Subjects will receive a weekly physical therapy session for four weeks. Subjects will be randomly assigned to two groups: T1 intervention group consisting of subjects who will receive manual therapy treatment and shock waves and T2 placebo group in which the subjects will receive manual therapy and placebo shock waves.
Subjects will be evaluated using sociodemographic variables such as age, sex, weight, height, Body Mass Index, educational level, work, smoking, alcohol and physical activity and function tests and quality of life questionnaires will be used. Measurements will be made pre and post-treatment, one month after the last evaluation, the measurements will be made again for follow-up. The intervention will be one day a week for four consecutive weeks.
The data will be collected using a self-implementing questionnaire, these data will be transferred to an excel table and then transferred to SPSS 19.0 (SPSS Inc., Chicago, IL) and MedCalc 19.1 (MedCalc Software Bv, Ostend, Belgium, http: // wwww .medcalc.org; 2019) for the subsequent statistical analysis, the data being stripped of any direct reference to the subject to preserve confidentiality.
The descriptive analysis will be carried out with means and standard deviations for continuous variables, frequencies and percentages for categorical variables. The normality of the continuous variables will be calculated with the Kolmogorov-Smirnov test and the homocedasticity of the sample with the Levene test.
All the statistical analysis will be carried out with a confidence level of 95% (p <0.05), for the comparison of the two groups we will use the Student's t-test and the Chi-square test. Comparisons between treatment group and placebo group will be made using repeated measures analysis of variance and ANOVA, followed by Bonferroni to compare measures replicated over time.
ngày
Xác minh lần cuối: | 06/30/2020 |
Đệ trình đầu tiên: | 07/06/2020 |
Đăng ký ước tính đã được gửi: | 07/13/2020 |
Đăng lần đầu: | 07/19/2020 |
Cập nhật lần cuối được gửi: | 07/13/2020 |
Cập nhật lần cuối đã đăng: | 07/19/2020 |
Ngày bắt đầu nghiên cứu thực tế: | 10/04/2020 |
Ngày hoàn thành chính ước tính: | 12/09/2020 |
Ngày hoàn thành nghiên cứu ước tính: | 01/28/2021 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Other: Manual therapy and extracorporeal radial shock waves therapy
Giai đoạn
Nhóm cánh tay
Cánh tay | Can thiệp / điều trị |
---|---|
Experimental: Blue Four sessions (one per week along one month) of manual therapy (15 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes (2000 shots approximately) of extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles at 4bars and 15 Hertzs | |
Placebo Comparator: Red Four sessions (one per week along one month) of manual therapy (15 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes of placebo extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles |
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: - Diagnosed of temporomandibular disorder by medical doctor. Exclusion Criteria: - Subjects who due to their own characteristics are not able to carry out the study tests |
Kết quả
Các biện pháp kết quả chính
1. Temporomandibular joint pain [Baseline]
2. Temporomandibular joint pain [At one month]
3. Temporomandibular joint pain Temporomandibular joint pain [At two months]
4. Neck function [Baseline]
5. Neck function [At one month]
6. Neck function [At two months]
Các biện pháp kết quả thứ cấp
1. Pain threshold [Baseline]
2. Pain threshold [At one month]
3. Pain threshold [At two months]
4. Headache impact in quality of life [Baseline]
5. Headache impact in quality of life [At one month]
6. Headache impact in quality of life [At two months]
7. Dizziness [Baseline]
8. Dizziness [At one month]
9. Dizziness [At two months]
10. Quality of life Measured with SF-12 [Baseline]
11. Quality of life Measured with SF-12 [At one month]
12. Quality of life Measured with SF-12 [At two months]
13. Temporomandibular joint function [Baseline]
14. Temporomandibular joint function [At one month]
15. Temporomandibular joint function [At two months]
16. Temporomandibular joint function [Baseline]
17. Temporomandibular joint function [At one month]
18. Temporomandibular joint function [At two months]