NCT05728905

Brief Summary

The objective of this study was to compare the short- and medium-term effects in pain and temporomandibular joint (TMJ) and function of implementing a manual therapy (MT) intervention treatment combined with a therapeutic exercise (TE) program, versus an isolated TE program and a non-intervention in patients with disc displacement with reduction (DDCR) with pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration 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

January 21, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

July 25, 2022

Last Update Submit

February 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Effects on pain when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction

    Pain prevalence within patients with disc displacement, evaluated using Visual Analogue Scale (VAS).

    3 months

  • Effects on function when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction

    Prevalence of jaw disfunction in patients with disc displacement, assessed using Jaw Functional Limitation Scale-20.

    3 months

Study Arms (3)

Therapeutic exercise

EXPERIMENTAL

The patients assigned to this group performed a self-treatment program that included three coordination exercises, two post-isometric relaxation (contraction-relaxation) and one self-traction. All exercises were performed in front of a mirror. It was performed every 3 hours, 5 times a day, for 4 weeks. The patient was instructed and supervised by a physiotherapist until they were executed correctly. All participants were provided with a video where the procedure and dosage of each exercise was described in detail.

Other: Therapeutic exercise

Therapeutic exercise + orthopedic manual therapy

EXPERIMENTAL

The patients assigned to this group performed the exercise program and also received a manual therapy treatment applied by a physiotherapist. Two sessions were held per week for 4 weeks (8 sessions). Treatment consisted of traction, mobilization, and friction massage of the muscles of mastication.

Other: Therapeutic exerciseOther: Orthopedic manual therapy

Control

NO INTERVENTION

The patients assigned to this group did not receive any type of intervention during the 4 weeks. They were asked not to change their habits or receive any other type of treatment.

Interventions

Intervention with therapeutic exercise: coordination, relaxation and disc recapture exercises.

Also known as: Exercise
Therapeutic exerciseTherapeutic exercise + orthopedic manual therapy

Intervention with orthopedic manual therapy: traction, ventral sliding and massage.

Also known as: Physiotherapy
Therapeutic exercise + orthopedic manual therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disc displacement with reduction diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders; in the last 30 days, any TMJ noise present during the exam or clicking detected with palpation during at least one of three repetitions of jaw opening, closing, protrusion, or laterotrusion movements.
  • equal or greater than 30 mm on the VAS scale
  • Age is greater than or equal to18 years.

You may not qualify if:

  • Participants were excluded if they had received interventions of TMJ surgery or TMJ steroid injections in the previous month, a rheumatoid diagnosis, neurological or psychiatric diseases, or pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic

Hermosillo, Sonora, 83150, Mexico

Location

Related Publications (8)

  • Au AR, Klineberg IJ. Isokinetic exercise management of temporomandibular joint clicking in young adults. J Prosthet Dent. 1993 Jul;70(1):33-9. doi: 10.1016/0022-3913(93)90034-l.

    PMID: 8366455BACKGROUND
  • Yoda T, Sakamoto I, Imai H, Honma Y, Shinjo Y, Takano A, Tsukahara H, Morita S, Miyamura J, Yoda Y, Sasaki Y, Tomizuka K, Takato T. A randomized controlled trial of therapeutic exercise for clicking due to disk anterior displacement with reduction in the temporomandibular joint. Cranio. 2003 Jan;21(1):10-6. doi: 10.1080/08869634.2003.11746226.

    PMID: 12555926BACKGROUND
  • Wanman A, Marklund S. Treatment outcome of supervised exercise, home exercise and bite splint therapy, respectively, in patients with symptomatic disc displacement with reduction: A randomised clinical trial. J Oral Rehabil. 2020 Feb;47(2):143-149. doi: 10.1111/joor.12888. Epub 2019 Sep 30.

    PMID: 31520538BACKGROUND
  • Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.

    PMID: 26294683BACKGROUND
  • Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.

    PMID: 22318373BACKGROUND
  • Campos Lopez A, De-Miguel EE, Malo-Urries M, Acedo TC. Mouth opening, jaw disability, neck disability, pressure pain thresholds, and myofascial trigger points in patients with disc displacement with reduction: A descriptive and comparative study. Cranio. 2024 May;42(3):309-315. doi: 10.1080/08869634.2021.1956214. Epub 2021 Aug 12.

    PMID: 34382921BACKGROUND
  • Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.

    PMID: 16813476BACKGROUND
  • Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Exercise TherapyExercisePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • ARMANDO CAMPOS

    FMO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessing physiotherapist did not know to which group the patient belongs
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized single blind clinical trial
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 25, 2022

First Posted

February 15, 2023

Study Start

January 21, 2020

Primary Completion

May 9, 2021

Study Completion

November 5, 2021

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations