NCT03555201

Brief Summary

Objective: To evaluate the efficacy of a manual therapy protocol composed of articulatory and myofascial techniques in patients with temporomandibular dysfunction (TMD). Methods: Randomized and controlled clinical study of patients presenting TMD. The subjects will be divided into 2 groups: 1) manual therapy group; 2) control group. There will be 4 treatment sessions during 4 weeks, with evaluations before and after the study, which include: severity of dysfunction (Helkimo Index), quality of life (Short Form 36 Health Survey), pressure pain threshold (algometer) ), cervical mobility (goniometer), mouth opening (caliper), pain intensity (Visual Analogue Scale) and cervical disability (Neck Disability Index).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

First Submitted

Initial submission to the registry

May 31, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

May 31, 2018

Last Update Submit

October 6, 2019

Conditions

Temporomandibular Dysfunction (TMD)

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Pain intensity scale. This scale consists of a horizontal line of 100 mm, delimited at one end by 0 mm (no pain) and at the other end by 100 mm (worst pain imaginable). This scale has shown a high validity and reliability for the assessment of the pain intensity of the patient

    8 weeks

Secondary Outcomes (6)

  • Severity and degree of dysfunction

    8 weeks

  • Health status

    8 weeks

  • Cervical disability

    8 weeks

  • Opening range of the mouth

    8 weeks

  • Pressure pain threshold

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Manual therapy

EXPERIMENTAL

Protocol of soft tissue techniques

Other: Regular treatment control.

Regular treatment control.

ACTIVE COMPARATOR

Regular treatment control.

Other: Manual therapy

Interventions

Manual therapyOTHER

protocol of soft tissues techniques

Regular treatment control.
Regular treatment control.OTHER

Regular treatment control.

Manual therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with TMD or myofascial pain according to the Helkimo index.
  • Use of the discharge splint, except in the 2 weeks prior to the study.
  • Age of the subjects between 18 and 65 years old.
  • Presence of TMD signs and symptoms in the 3 months prior to the study, such as limitations in movements, pain and / or deviation during opening of the mouth, muscular sensitivity, and sounds produced by the joint during opening of the mouth.
  • Limitation of active vertical opening of the mouth \<40 mm.
  • Bilateral pain that surrounds the areas of the temporal and the masseter.
  • Presence of at least one trigger point in the masseter and temporal muscles.
  • Patients who sign the informed consent.

You may not qualify if:

  • That they did not use the splint, except in the 2 weeks prior to the study.
  • Presence of systemic, rheumatic or central nervous system diseases.
  • Trauma or previous surgical intervention in the ATM region.
  • History of some type of treatment (physiotherapy or acupuncture) in the 3 months prior to the study.
  • Use of analgesics or muscle relaxants at least 24 hours before the evaluations and during the treatment period.
  • Presence of another type of orofacial pain disorder.
  • Presence of signs or symptoms of disc displacement, osteoarthritis or TMJ arthritis.
  • Positive extension-rotation test (vertebral artery test or Klein test) or cerebrovascular changes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 13, 2018

Study Start

May 31, 2018

Primary Completion

July 31, 2018

Study Completion

August 15, 2018

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations

ES(1)