NCT04811495

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 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

February 5, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

24 days

First QC Date

March 19, 2021

Last Update Submit

March 19, 2021

Conditions

Keywords

range of motion, articulardisorders, temporomandibular joint

Outcome Measures

Primary Outcomes (3)

  • Range motion

    The range of movement in the temporomandibular joint is assessed.

    14 days

  • VAS

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

    14 days

  • Strength

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

    14 days

Study Arms (1)

patient with temporomandibular joint disorders

EXPERIMENTAL
Other: Physiotherapy treatment

Interventions

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

patient with temporomandibular joint disorders

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Men
  • No temporomandibular joint pain or hyperlaxity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564310/

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 23, 2021

Study Start

February 5, 2021

Primary Completion

March 1, 2021

Study Completion

March 19, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations