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Disorders, Temporomandibular JointNCT04811495

Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity

A study testing Physiotherapy treatment in people with Disorders, Temporomandibular Joint and Range of Motion, Articular, run by Universidad Católica de Ávila at 1 site in Spain.

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

A 14-day physiotherapy treatment for temporomandibular joint hyperlaxity is established. Pre-intervention measurements and intermediate and end-of-treatment measurements are taken. Range of movement, algometry and muscle balance are assessed. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Physiotherapy treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteSpain
Study dates
5 Feb 2021to 19 Mar 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 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Woman with temporomandicular joint pain for six months and diagnosed with hyperlaxity in the joint.

Who cannot join

  • Men
  • No temporomandibular joint pain or hyperlaxity

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Católica de Ávila

    Ávila, 05005

Other trials in Spain

About this study

Official title: Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity: a Case Report.

A 14-day physiotherapy treatment for temporomandibular joint hyperlaxity is established. Pre-intervention measurements and intermediate and end-of-treatment measurements are taken. Range of movement, algometry and muscle balance are assessed.

Being tested
Physiotherapy treatment
Keywords
range of motion, articular, disorders, temporomandibular joint
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.

  • Physiotherapy treatmentOther

    A treatment plan is carried out which aims to improve pain, muscle balance and range of motion of the temporomandibular joint.

Study groups in NCT04811495
Study groupRoleWhat they receive
patient with temporomandibular joint disordersExperimentalNot described
Receives: Other: Physiotherapy treatment

What is being measured

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

  1. Range motion

    The range of movement in the temporomandibular joint is assessed.

    Measured: 14 days

  2. VAS

    Pain in the temporomandibular artiuclation measured with an algometer and VAS is assessed.

    Measured: 14 days

  3. Strength

    The strength of the temporomandibular joint musculature measured with an algometer is assessed.

    Measured: 14 days

Timeline

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

  1. First posted23 Mar 2021
  2. Study start5 Feb 2021
  3. Primary completion1 Mar 2021
  4. Study completion19 Mar 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811495
Sponsor's protocol ID
19/03/2021
Status last verified
Mar 2021
First submitted
19 Mar 2021
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Buvinic S, Balanta-Melo J, Kupczik K, Vasquez W, Beato C, Toro-Ibacache V. Muscle-Bone Crosstalk in the Masticatory System: From Biomechanical to Molecular Interactions. Front Endocrinol (Lausanne). 2021 Mar 1;11:606947. doi: 10.3389/fendo.2020.606947. eCollection 2020.

    PubMed 33732211

  • Al-Jewair T, Shibeika D, Ohrbach R. Temporomandibular Disorders and Their Association with Sleep Disorders in Adults: A Systematic Review. J Oral Facial Pain Headache. 2021 Winter;35(1):41-53. doi: 10.11607/ofph.2780.

    PubMed 33730126

  • Kaya DI, Ataoglu H. Botulinum toxin treatment of temporomandibular joint pain in patients with bruxism: A prospective and randomized clinical study. Niger J Clin Pract. 2021 Mar;24(3):412-417. doi: 10.4103/njcp.njcp_251_20.

    PubMed 33723117

  • Angelo DF, Moreira A, Sanz D, Sao Joao R. Hearing changes after temporomandibular joint arthroscopy: a prospective study. Int J Oral Maxillofac Surg. 2021 Nov;50(11):1491-1495. doi: 10.1016/j.ijom.2021.02.013. Epub 2021 Mar 11.

    PubMed 33714614

  • Candido Dos Reis A, Theodoro de Oliveira T, Vidal CL, Borsatto MC, Lima da Costa Valente M. Effect of Auricular Acupuncture on the Reduction of Symptoms Related to Sleep Disorders, Anxiety and Temporomandibular Disorder (TMD). Altern Ther Health Med. 2021 Mar;27(2):22-26.

    PubMed 33711819

  • Asquini G, Rushton A, Pitance L, Heneghan N, Falla D. The effectiveness of manual therapy applied to craniomandibular structures in the treatment of temporomandibular disorders: protocol for a systematic review. Syst Rev. 2021 Mar 8;10(1):70. doi: 10.1186/s13643-021-01623-7.

    PubMed 33685496

  • Memmedova F, Emre U, Yalin OO, Dogan OC. Evaluation of temporomandibular joint disorder in headache patients. Neurol Sci. 2021 Nov;42(11):4503-4509. doi: 10.1007/s10072-021-05119-z. Epub 2021 Feb 18.

    PubMed 33604763

  • Castien RF, Scholten-Peeters GG. Letter to the Editor concerning 'Effects of physical therapy for temporomandibular disorders on headache pain intensity: A systematic review' by van der Meer et al. Musculoskelet Sci Pract. 2021 Jun;53:102324. doi: 10.1016/j.msksp.2021.102324. Epub 2021 Feb 16. No abstract available.

    PubMed 33602632

  • Wu M, Cai J, Yu Y, Hu S, Wang Y, Wu M. Therapeutic Agents for the Treatment of Temporomandibular Joint Disorders: Progress and Perspective. Front Pharmacol. 2021 Jan 29;11:596099. doi: 10.3389/fphar.2020.596099. eCollection 2020.

    PubMed 33584275

  • Peixoto KO, da Silva Bezerra A, Melo RA, de Resende CMBM, de Almeida EO, Barbosa GAS. Short-Term Effect of Scalp Acupuncture on Pain, Sleep Disorders, and Quality of Life in Patients with Temporomandibular Disorders: A A Randomized Clinical Trial. Pain Med. 2021 Apr 20;22(4):905-914. doi: 10.1093/pm/pnab048.

    PubMed 33561277

  • Onoda N, Mikami T, Saito N, Kobayashi T. Evaluation of oral health-related quality of life in patients with temporomandibular disorders. Cranio. 2023 Nov;41(6):486-493. doi: 10.1080/08869634.2021.1883378. Epub 2021 Feb 8.

    PubMed 33554774

  • Nahian A, Mathew Jr J. Osteopathic Manipulative Treatment: Facial Muscle Energy, Direct MFR, and BLT Procedure - for TMJ Dysfunction. 2023 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564310/

    PubMed 33231980

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy treatment in people with Disorders, Temporomandibular Joint and Range of Motion, Articular, run by Universidad Católica de Ávila at 1 site in Spain.

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 1 inclusion and 2 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 23 Mar 2021. 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 Spain. 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?

Range motion (time frame: 14 days). The study lists 3 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 NCT04811495, which also lists 12 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 23 Mar 2021.

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