NCT04122352

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

October 1, 2019

Last Update Submit

April 27, 2020

Conditions

Keywords

temporomandibular jointtrigger pointsmyofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Graded Chronic Pain Scale version 2 (GCPS v2)

    Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment.

  • Jaw Range of Motions (ROM)

    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.

  • Jaw Functional Limitation Scale-8 (JFLS-8)

    The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment.

  • Pain Pressure Threshold (PPT)

    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.

Study Arms (2)

Exercises + ischemic compression group

EXPERIMENTAL

volunteer patients with temporomandibular joint dysfunction with trigger points

Other: Ischemic compressionOther: Exercises (Rocabodo's 6x6 exercises and posture exercises)

Exercises group

OTHER

volunteer patients with temporomandibular joint dysfunction with trigger points

Other: Exercises (Rocabodo's 6x6 exercises and posture exercises)

Interventions

Ischemic compression was performed 3 times ; after the initial evaluation, after the first week evaulation and after the second week evaulations.

Exercises + ischemic compression group

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.

Exercises + ischemic compression groupExercises group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Bakırköy / Florya, 34153, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

MeSH Terms

Conditions

Temporomandibular Joint DisordersMyofascial Pain Syndromes

Interventions

AcupressureExercise

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Olcay Şakar, Prof. Dr.

    Istanbul University

    PRINCIPAL INVESTIGATOR
  • Hanifegül Taşkıran, Prof. Dr.

    IstanbulAydın

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individuals included in the study were randomized into two groups ; Group 1 : Exercises + ischemic compression Group 2 : Exercises Rocabado's 6x6 jaw exercises are shown to be applied to both groups for 4 weeks. After 1 week, posture exercises are added to the exercise programs of the patients. In addition to the exercises, Group 1 is given a total of 4 sessions of trigger point treatment after the initial evaluation, 1 week later, 2 weeks later and 4 weeks later.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof. Dr, PhD

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 10, 2019

Study Start

July 7, 2019

Primary Completion

December 7, 2019

Study Completion

March 15, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations