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Temporomandibular DisorderNCT05728905

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

A study testing Therapeutic exercise and Orthopedic manual therapy in people with Temporomandibular Disorder and Manual Therapy, run by Fisioterapia Manual Ortopedica at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Temporomandibular Disorder, Manual Therapy
What is being tested?
Therapeutic exercise and Orthopedic manual therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteMexico
Study dates
21 Jan 2020to 5 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Clinic

    Hermosillo, Sonora, 83150

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Therapeutic exercise, Orthopedic manual therapy
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic exerciseOther

    Also called Exercise

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

  • Orthopedic manual therapyOther

    Also called Physiotherapy

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

Study groups in NCT05728905
Study groupRoleWhat they receive
Therapeutic exerciseExperimentalThe 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.
Receives: Other: Therapeutic exercise
Therapeutic exercise + orthopedic manual therapyExperimentalThe 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.
Receives: Other: Therapeutic exercise; Other: Orthopedic manual therapy
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3 months

  2. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2023
  2. Study start21 Jan 2020
  3. Primary completion9 May 2021
  4. Study completion5 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized single blind clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05728905
Sponsor's protocol ID
FMO Fisioterapia
Status last verified
Feb 2023
First submitted
25 Jul 2022
Last updated
15 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8366455

  • 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.

    PubMed 12555926

  • 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.

    PubMed 31520538

  • 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.

    PubMed 26294683

  • 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.

    PubMed 22318373

  • 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.

    PubMed 34382921

  • 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.

    PubMed 16813476

  • 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.

    PubMed 23768273

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic exercise and Orthopedic manual therapy in people with Temporomandibular Disorder and Manual Therapy, run by Fisioterapia Manual Ortopedica at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects on pain when implementing an orthopedic manual therapy intervention compared to an exercise program intervention in patients with painful disc displacement with reduction (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05728905, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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