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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00993577
Other study ID # 155/04
Secondary ID
Status Completed
Phase Phase 1
First received October 9, 2009
Last updated October 29, 2009
Start date February 2004
Est. completion date March 2007

Study information

Verified date October 2009
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).

Physical therapy is of importance in the treatment of myogenic temporomandibular disorders (TMD). Both stretching exercise and global posture reeducation are equally effective in the treatment of TMD.


Description:

Purpose: To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).

Methods: A total of 24 subjects with TMD were randomized into two treatment groups: GPR, where therapy involved muscle global chain stretching, or SS, with conventional static stretching. Eight treatment sessions lasting 40 minutes each (weekly) were performed. Assessments were conducted at baseline, immediately after treatment end, and again two months later. Measurements included pain intensity at the temporomandibular joint, headache, cervicalgia (visual analogue scale - VAS) and teeth clenching. Additionally, electromyographic activity and pain thresholds were measured at the masseter, anterior temporalis, sternocleidomastoid, and upper trapezius muscles. Two-way analysis of variance (ANOVA) with Tukey post-hoc test was used for in-between group comparisons. Significance level was 0.05.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2007
Est. primary completion date July 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria:

- Helkimo index III,

- Myogenic TMD, AND

- Presence of para-functional habits, such as: bruxism, teeth clenching, mouth-breathing and lip biting.

Exclusion Criteria:

- Surgery or trauma in the orofacial region,

- Systemic or degenerative diseases, OR

- Undergoing odontological, psychological, or physical therapy treatments.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Stretching exercises
Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
Device:
Stretching exercises
Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.
Exercises
Treatment consisted of eight individual sessions (once a week), over two months. At the first 10 minutes of sessions, patients rested (supine position) with all limbs relaxed. Manual therapy maneuvers were made as described by Bienfait,17 associated to breathing exercises, in order to stretch the fasciae that recover the shoulders, as well as the cervical spine muscles. After that, stretching treatment (global or static) was conducted for another 30 minutes.

Locations

Country Name City State
Brazil Physicaltherapy, Speech and Ocupational Therapy Department Rua Cipotânea, 51 São Paulo
Brazil Clinical Hospital of University of São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain 2 Yes
Secondary Quality of life 2 Yes
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