NCT03622684

Brief Summary

Temporomandibular joint disorders are ranked third among the most common stomatological diseases after dental caries and periodontal problems. Type of dysfunction is determined by environmental, genetic and psycho-emotional factors. It has been observed that increasing level of stress leads to the increase of harmful parafunctional habits in the stomatognathic system whose long-term effect prevents the ability of the organism to compensate and adapt the function, which contributes to the pain within the masticatory system. Nowadays applied methods in treatment of temporomandibular joint disorders are still under investigation. However, they have not been developed effectively yet. Satisfactory methods of masticatory muscle relaxation (with the exception for drug treatment) are only related to mental patients. Significant impact factor and psycho-emotional stress in the etiology of dysfunction indicate the need of the routine approach in the treatment of patients with temporomandibular joint disorders to be changed. The attempt to cooperate with a psychologist may facilitate the effectiveness of traditional rehabilitation of patients with dysfunction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

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

March 20, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

November 21, 2017

Last Update Submit

August 7, 2018

Conditions

Keywords

TMJ- temporomandibular joint-disorderMuscle relaxationPsychoemotional factorStress

Outcome Measures

Primary Outcomes (1)

  • Number of patients with assesment of psycho emotional factor and stress

    Analyses based on a survey questionnaire in the development of their own - scoring scale

    2 years

Secondary Outcomes (2)

  • Incidence of CIB values in both groups before and after treatments relaxation assessed by specialized statistical package "R" i386

    1 Month

  • Incidence of OBC values in both groups before and after treatments relaxation assessed by specialized statistical package "R" i386

    1 Month

Study Arms (1)

Muscle relaxation according to Jacobson

EXPERIMENTAL

. Does the use of the method of progressive relaxation according to Jacobson will be beneficial to reduce pain and improve the functioning of the stomatognathic system being evaluated in clinical trials?

Behavioral: Muscle relaxation according to Jacobson

Interventions

Muscle relaxation according to Jacobson

Eligibility Criteria

Age20 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe study included 100 patients of both sexes, aged from 20 to 35 years who were diagnosed with pain due to temporomandibular joint disorders accompanied with high muscle tension of masticatory muscles.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good general health
  • painful form of temporomandibular joint disorders- masticatory muscles pain with high muscle tension
  • pain lasting for at least 3 weeks prior to admission
  • patients with full arches without previous orthodontic treatment.

You may not qualify if:

  • joint component of functional disorders (pain in the temporomandibular joints, acoustic symptoms)
  • deterioration of the posture resulting from relaxation training (aggravation of muscular pain, worsening of mental state)
  • unstable musculoskeletal system (frequent painful muscle spasms), tetanus, other diseases that prevent the patient from continuing the study (fever)
  • the lack of the patient's informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Alvarez-Arenal A, Junquera LM, Fernandez JP, Gonzalez I, Olay S. Effect of occlusal splint and transcutaneous electric nerve stimulation on the signs and symptoms of temporomandibular disorders in patients with bruxism. J Oral Rehabil. 2002 Sep;29(9):858-63. doi: 10.1046/j.1365-2842.2002.00923.x.

    PMID: 12366541BACKGROUND
  • Almoznino G, Zini A, Zakuto A, Sharav Y, Haviv Y, Hadad A, Chweidan H, Yarom N, Benoliel R. Oral Health-Related Quality of Life in Patients with Temporomandibular Disorders. J Oral Facial Pain Headache. 2015 Summer;29(3):231-41. doi: 10.11607/ofph.1413.

    PMID: 26244431BACKGROUND
  • Costa YM, Porporatti AL, Stuginski-Barbosa J, Bonjardim LR, Conti PC. Additional effect of occlusal splints on the improvement of psychological aspects in temporomandibular disorder subjects: A randomized controlled trial. Arch Oral Biol. 2015 May;60(5):738-44. doi: 10.1016/j.archoralbio.2015.02.005. Epub 2015 Feb 20.

    PMID: 25768709BACKGROUND
  • Jacobson E. Interview with Edmund Jacobson. Biofeedback Self Regul. 1978 Sep;3(3):287-300. doi: 10.1007/BF00999297. No abstract available.

    PMID: 728486BACKGROUND
  • Golombek U. [Progressive muscle relaxation (PMR) according to Jacobson in a department of psychiatry and psychotherapy - empirical results]. Psychiatr Prax. 2001 Nov;28(8):402-4. doi: 10.1055/s-2001-18615. German.

    PMID: 11721228BACKGROUND
  • Wilk C, Turkoski B. Progressive muscle relaxation in cardiac rehabilitation: a pilot study. Rehabil Nurs. 2001 Nov-Dec;26(6):238-42; discussion 243. doi: 10.1002/j.2048-7940.2001.tb01963.x.

    PMID: 12035725BACKGROUND
  • Grossi ML, Goldberg MB, Locker D, Tenenbaum HC. Irritable bowel syndrome patients versus responding and nonresponding temporomandibular disorder patients: a neuropsychologic profile comparative study. Int J Prosthodont. 2008 May-Jun;21(3):201-9.

    PMID: 18548956BACKGROUND
  • Takemura T, Takahashi T, Fukuda M, Ohnuki T, Asunuma T, Masuda Y, Kondoh H, Kanbayashi T, Shimizu T. A psychological study on patients with masticatory muscle disorder and sleep bruxism. Cranio. 2006 Jul;24(3):191-6. doi: 10.1179/crn.2006.031.

    PMID: 16933460BACKGROUND
  • van Selms MK, Lobbezoo F, Visscher CM, Naeije M. Myofascial temporomandibular disorder pain, parafunctions and psychological stress. J Oral Rehabil. 2008 Jan;35(1):45-52. doi: 10.1111/j.1365-2842.2007.01795.x.

    PMID: 18190360BACKGROUND
  • Hutchings DF, Reinking RH. Tension headaches: what form of therapy is most effective? Biofeedback Self Regul. 1976 Jun;1(2):183-90. doi: 10.1007/BF00998585.

    PMID: 791381BACKGROUND

Related Links

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction SyndromeTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic 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
Doctor of medical sciences, assistant, research worker, principal investigator of Jagiellonian University, Medical College, Prosthodontic Department, Room of Functional Disorders of Masticatory System, Poland, Krakow

Study Record Dates

First Submitted

November 21, 2017

First Posted

August 9, 2018

Study Start

March 20, 2014

Primary Completion

May 20, 2015

Study Completion

June 20, 2016

Last Updated

August 9, 2018

Record last verified: 2018-08