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Effects on Pain and Function of Orthopedic Manual Therapy in Patients With Painful Disc Displacement With Reduction

Primary Purpose

Temporomandibular Disorder, Manual Therapy

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Therapeutic exercise
Orthopedic manual therapy
Sponsored by
Fisioterapia Manual Ortopedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Therapeutic exercise

Therapeutic exercise + orthopedic manual therapy

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
February 12, 2023
Sponsor
Fisioterapia Manual Ortopedica
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1. Study Identification

Unique Protocol Identification Number
NCT05728905
Brief Title
Effects on Pain and Function of Orthopedic Manual Therapy in Patients With Painful Disc Displacement With Reduction
Official Title
Effects on Pain and Function When Implementing an Orthopedic Manual Therapy Intervention Compared to an Exercise Program Intervention in Patients With Painful Disc Displacement With Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
May 9, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fisioterapia Manual Ortopedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study Design: The study adopted a single-blind, randomized, controlled clinical trial approach. Adults with disc displacement with reduction clinical diagnosis, pain and loss of function were eligible for inclusion. Intervention: Patients in the study were randomized into three groups, 25 subjects to the manual therapy and therapeutic exercise group, 25 to the therapeutic exercise group and 25 to the no intervention group. Subjects were excluded if there was presence of surgical history, dentistry treatment and use of medication. The dependent variables were the presence of clicking, TMJ function, cervical disability, pain, and range of motion of the TMJ. Subjects in every group were assessed after four weeks of intervention and after eight weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Manual Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized single blind clinical trial
Masking
Outcomes Assessor
Masking Description
The assessing physiotherapist did not know to which group the patient belongs
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic exercise + orthopedic manual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Other Intervention Name(s)
Exercise
Intervention Description
Intervention with therapeutic exercise: coordination, relaxation and disc recapture exercises.
Intervention Type
Other
Intervention Name(s)
Orthopedic manual therapy
Other Intervention Name(s)
Physiotherapy
Intervention Description
Intervention with orthopedic manual therapy: traction, ventral sliding and massage.
Primary Outcome Measure Information:
Title
Effects on pain when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction
Description
Pain prevalence within patients with disc displacement, evaluated using Visual Analogue Scale (VAS).
Time Frame
3 months
Title
Effects on function when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction
Description
Prevalence of jaw disfunction in patients with disc displacement, assessed using Jaw Functional Limitation Scale-20.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ARMANDO CAMPOS
Organizational Affiliation
FMO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83150
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8366455
Citation
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.
Results Reference
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PubMed Identifier
12555926
Citation
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.
Results Reference
background
PubMed Identifier
31520538
Citation
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.
Results Reference
background
PubMed Identifier
26294683
Citation
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.
Results Reference
background
PubMed Identifier
22318373
Citation
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.
Results Reference
background
PubMed Identifier
34382921
Citation
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. 2021 Aug 12:1-7. doi: 10.1080/08869634.2021.1956214. Online ahead of print.
Results Reference
background
PubMed Identifier
16813476
Citation
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.
Results Reference
background
PubMed Identifier
23768273
Citation
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.
Results Reference
result

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Effects on Pain and Function of Orthopedic Manual Therapy in Patients With Painful Disc Displacement With Reduction

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