- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122352
The Effects of Trigger Point Treatment in Temporomandibular Joint Dysfunction
The Effects of Trigger Point Treatment on Pain and Functionality in Temporomandibular Joint Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
TMD is most common of pain and functional limitations of jaw. The ischemic compression and the exercises (Rocabado's 6x6 exercises and posture exercises) each relieve pain and increase funcitonality on TMD but which one has the more effect should be investigated.
The ROCABODO's 6x6 exercise program, which is a special for temporomandibular joint, includes repetitive movements that include patient education, patient self-care, lifestyle modifications, and recognizing which actions have the effect of increasing the symptoms of an individual's active participation. The repetitive movements relax the chewing muscles and reduce pain by helping the synovial fluid move along the joint surfaces, increasing circulation, removing joint nutrition, and removing the metabolites of articular cartilage.
Postural exercise is commonly used for pain/tension in neck or back, but can also be applied in the orofacial region, aiming to relief muscle symptoms such as pain, tension, stiffness, and tiredness ,by improving the position of the head or the mandibular. It is believed that wrong head position can cause muscle pain due to acceleration of muscle activity in the neck and jaw muscles, as well as postural reflex. Postural exercise includes head posture correction and myofascial release.
Ischemic compression, that is a frequently used manual pressure technique, is a pressure application that is applied with the thumb to the maximum tolerable pain point on the trigger points. With this application, the sense of pain signals reduce pain by inhibiting the sense of touch signals.
The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, ROM, PPT and functionality on patient with TMD. 42 patients were randomized into 2 groups : Group 2 (n:21) received only exercises (Rocabado's 6x6 exercises and posture exercises) as treatment, Group 1(n:21) received exercises (Rocabado's 6x6 exercises and posture exercises) and ischemic compression as treatment.The rest, activity and night pain in activity were assessed by visual analog scale, ROM assessed by a ruler and PPT assessed by a digital algometer at baseline (before treatment), after 1week treatment, after 2 week treatment and after 4 week treatment. Chronic pain severity were assessed by Graded Chronic Pain Scale version 2 and functionality were assessed by Jaw Function Limitation Scale-8 at baseline (before treatment) and after 4 week treatment. The efect size was calculated for the assessments used in the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bakırköy / Florya
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Istanbul, Bakırköy / Florya, Turkey, 34153
- Istanbul Aydin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercises + ischemic compression group
volunteer patients with temporomandibular joint dysfunction with trigger points
|
Ischemic compression was performed 3 times ; after the initial evaluation, after the first week evaulation and after the second week evaulations.
Rocabodo's 6x6 exercises exercise was shown to be administered for 4 weeks.
After the first week evaluation, posture exercises are added to the exercise programs of the patients.
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Other: Exercises group
volunteer patients with temporomandibular joint dysfunction with trigger points
|
Rocabodo's 6x6 exercises exercise was shown to be administered for 4 weeks.
After the first week evaluation, posture exercises are added to the exercise programs of the patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 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.
|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graded Chronic Pain Scale version 2 (GCPS v2)
Time Frame: Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment.
|
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.
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Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment.
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Jaw Range of Motions (ROM)
Time Frame: 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.
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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.
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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.
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Jaw Functional Limitation Scale-8 (JFLS-8)
Time Frame: The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment.
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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.
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The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment.
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Pain Pressure Threshold (PPT)
Time Frame: 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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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.
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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olcay Şakar, Prof. Dr., Istanbul University
- Principal Investigator: Hanifegül Taşkıran, Prof. Dr., IstanbulAydın
Publications and helpful links
General Publications
- Shaffer SM, Brismee 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.
- 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.
- 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.
- 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/j.jmpt.2013.07.001. Epub 2013 Aug 28.
- 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, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Shaffer SM, Brismee 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/81
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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