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NCT05728905 Clinical Trial

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

Temporomandibular Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05728905
Other study ID # FMO Fisioterapia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2020
Est. completion date November 5, 2021

Study information
Verified date February 2023
Source Fisioterapia Manual Ortopedica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date November 5, 2021
Est. primary completion date May 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Therapeutic exercise
Intervention with therapeutic exercise: coordination, relaxation and disc recapture exercises.
• Orthopedic manual therapy
Intervention with orthopedic manual therapy: traction, ventral sliding and massage.

Locations
Country Name City State
Mexico Clinic Hermosillo Sonora

Sponsors (1)
Lead Sponsor Collaborator
Fisioterapia Manual Ortopedica

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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