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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2020
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms

  • Joint Diseases
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
Ischemic compression
Ischemic compression was performed 3 times ; after the initial evaluation, after the first week evaulation and after the second week evaulations.
Exercises (Rocabodo's 6x6 exercises and posture exercises)
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.

Locations

Country Name City State
Turkey Istanbul Aydin University Istanbul Bakirköy / Florya

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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

Outcome

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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