Temporomandibular Joint Dysfunction Clinical Trial
Official title:
The Effects of Trigger Point Treatment on Pain and Functionality in Temporomandibular Joint Dysfunction
NCT number | NCT04122352 |
Other study ID # | 2019/81 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 7, 2019 |
Est. completion date | March 15, 2020 |
Verified date | April 2020 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, range of motion(ROM), pain pressure threshold (PPT) and functionality on patient with temporomandibular joint dysfunction.(TMD)
Status | Completed |
Enrollment | 42 |
Est. completion date | March 15, 2020 |
Est. primary completion date | December 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diagnosis of TMD according to the criteria of DC / TMD (Diagnostic Criteria for Temporomandibular Disorders) - Detection of trigger point during palpation of masticatory muscles - Volunteer to participate in the study Exclusion Criteria: - To have undergone TMJ or cervical surgery and have been treated from these regions in the last 3 months - Presence of rheumatic disease including TMJ - Patients with TMJ instability or fractures - Cases with cognitive impairment - Presence of chronic pain such as trigeminal neuralgia - Cases who do not regularly participate in treatment are excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Aydin University | Istanbul | Bakirköy / Florya |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa |
Turkey,
Cagnie B, Dewitte V, Coppieters I, Van Oosterwijck J, Cools A, Danneels L. Effect of ischemic compression on trigger points in the neck and shoulder muscles in office workers: a cohort study. J Manipulative Physiol Ther. 2013 Oct;36(8):482-9. doi: 10.1016 — View Citation
McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25. Review. — View Citation
Mulet M, Decker KL, Look JO, Lenton PA, Schiffman EL. A randomized clinical trial assessing the efficacy of adding 6 x 6 exercises to self-care for the treatment of masticatory myofascial pain. J Orofac Pain. 2007 Fall;21(4):318-28. — View Citation
Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, — View Citation
Shaffer SM, Brismée JM, Sizer PS, Courtney CA. Temporomandibular disorders. Part 1: anatomy and examination/diagnosis. J Man Manip Ther. 2014 Feb;22(1):2-12. doi: 10.1179/2042618613Y.0000000060. Review. — View Citation
Shaffer SM, Brismée JM, Sizer PS, Courtney CA. Temporomandibular disorders. Part 2: conservative management. J Man Manip Ther. 2014 Feb;22(1):13-23. doi: 10.1179/2042618613Y.0000000061. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) | Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity and at night (on a 0-10 numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain). The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment. | The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment. | |
Secondary | Graded Chronic Pain Scale version 2 (GCPS v2) | Chronic pain severity was assesed using the GCPS v2. Scores are calculated for 3 subscales: the characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain; the disability score, which ranges from 0-100, is calculated as the mean rating for difficulty performing daily, social, and work activities; and the disability points score, which ranges from 0-3, is derived from a combination of ranked categories of number of disability days and disability score. The 3 subscale scores are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting. Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment. | Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment. | |
Secondary | Jaw Range of Motions (ROM) | Jaw ROM measurements of unassisted painless mouth opening, maximum unassisted opening, maximum assisted opening, right lateral excursion and left lateral excursion were taken using a ruler. ROM were assessed by a ruler at before treatment, 1 week after start of treatment, 2 week after start of treatment and 4 week after start of treatment. | ROM were assessed by a ruler at before and after 1 week of treatment, before and after 2 week of treatment, before and after 4 week of treatment. | |
Secondary | Jaw Functional Limitation Scale-8 (JFLS-8) | The functionality was assessed using JFLS-8. The JFLS-8 was developed as an 8-item global scale for overall functional limitation of the masticatory system. All items are evaluated between 0 and 10. (0: no restrictions, 10: maximum restrictions) JFLS-8 are calculated as the mean of the available items. The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment. | The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment. | |
Secondary | Pain Pressure Threshold (PPT) | PPT was assessed using the digital algometer. Assessment was performed massater, temporalis, lateral of the temporomandibular joint, sternocleidomastoideus and trapezius. PPT was evaluated by a digital algometer at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment. | PPT was evaluated by a digital algometer at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment. |
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