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WithdrawnNCT01954511Updated Sep 27, 2019

Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders

An interventional study of Manual therapy and Manual therapy in Temporomandibular Joint Dysfunction Syndrome, sponsored by Universidade Federal de Sao Carlos. Withdrawn. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Universidade Federal de Sao Carlos · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Project was suspended for personal issues
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
Female
01

Study summary

The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.

Read the detailed description

Temporomandibular disorder (TMD) is a general term that refers to disorders associated with the temporomandibular joint (TMJ) and the masticatory muscles. Among the main symptoms are pre-auricular pain (in the region of the TMJ) and/or pain in the masticatory muscles.

It's usual to observe that subjects with TMD also present cervical alteration. Beside this, cervical postural alterations produced by muscle tension can influence mandibular position.

The intervention protocol was based on manual therapy, stabilization exercises and stretching.

The technique are:.

  1. Upper cervical flexion mobilization;
  2. C5 central posterior-anterior mobilization;
  3. Stabilization exercise: Cranio-cervical flexor stabilization exercise
  4. Stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid
02

Conditions studied

  • Temporomandibular Joint Dysfunction Syndrome

Keywords

  • Stomatognathic diseases;
  • Temporomandibular Joint Dysfunction Syndrome
03

In context

Temporomandibular Joint Dysfunction Syndrome

416 studies on the registry are indexed under Temporomandibular Joint Dysfunction Syndrome; 69 are open to participants now.

Browse Temporomandibular Joint Dysfunction Syndrome studies →

Lead sponsor

Universidade Federal de Sao Carlos is the lead sponsor of 86 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with myogenic or mixed temporomandibular disorders

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed with arthrogenic or discogenic temporomandibular disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    Manual therapy

    Upper cervical flexion mobilization, C5 central posterior-anterior mobilization, Pressure biofeedback device

    Other: Manual therapy · Device: Pressure biofeedback device

Interventions

  • OtherManual therapy

    The patient was supine with the cervical spine in a neutral position. The therapist brought about a contact of the occipital bone with the first finger and medial aspect of the hand, and other hand over the frontal region of the patient's head. The mobilizing force was delivered by flexing the upper cervical region using a combination of cephalic traction with the occipital hand and caudal pressure with the frontal hand. This technique was applied for 10 minutes

    Also known as: Upper cervical flexion mobilization

  • OtherManual therapy

    The patient was prone with the cervical spine in a neutral position. The therapist placed the tips of his thumbs on the posterior surface of the C5 spinous process, while the other fingers rested gently around the patients' neck. This technique was applied for 9 minutes

    Also known as: C5 central posterior-anterior mobilization

  • DevicePressure biofeedback device

    Device: Stabilizer - Chattanooga Group Inc., Chattanooga, Tennessee, USA The cranio-cervical flexor stabilization exercise was done 10 times holding 10 seconds the flexing position graded through feedback from a pressure biofeedback device

    Also known as: Stabilizer

06

What researchers measure

Primary outcomes

  1. Changing in maximum mouth opening pain free

    The clinical signs was based on Research Diagnostic Criteria protocol and it was measured maximum mouth opening pain free using a caliper ((Somet, 150mm, Inox, Czechoslovakia)

    Time frame: Before and 5 days follow-up intervetion

Secondary outcomes

  1. Changing of Pain

    To evaluate pain it was applied a scale from Research Diagnostic Criteria protocol, that consists of a line scored from 0 to 10, where 0 represents no pain and 10 the worst pain that the subject has experienced, allowing it to check the number that features their pain at the moment.

    Time frame: Before and 5 days follow-up intervetion

Other outcomes

  1. Changing in Mandibular Function Impairment Questionnaire -MFIQ

    To evaluated mandibular function was used the Mandibular Function Impairment Questionnaire

    Time frame: Before and 5 days follow-up intervetion

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2013
First posted
Oct 1, 2013
Start
Jul 2012
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
Sep 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01954511
Lead sponsor
Universidade Federal de Sao Carlos
Responsible party
Bruno Leonardo da Silva Grüninger (Pt, Universidade Federal de Sao Carlos) — Principal investigator
First posted
Oct 1, 2013
Start date
Jul 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Sep 27, 2019

Study contacts

Ana Beatriz Oliveira, Phd
study director · Clinical professor - UFSCar
Letícia Bojikian Calixtre, Pt
principal investigator · UFSCar
Francisco Alburquerque Sendín, Phd
principal investigator · University of Salamanca
Melina Nevoeiro Haik, MSc
principal investigator · UFSCar

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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