Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain

NCT03339739 | Completed

• 1 other identifier: PROPRGFO_2013/004
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The effectiveness of mandibular exercises as a treatment of muscular Orofacial Pain is yet unknown. This study hypothesized that training exercises can be an effective therapy improving pain perception.

Conditions

Temporomandibular Disorders

Keywords

Musculoskeletal Pain; Orofacial Pain; Physical Therapy Modalities; Oral Contraceptives; Mandibular Diseases; Muscular Diseases; Risk factors; Contraceptive Usage; Pain, Chronic; Craniomandibular Disorders

Outcome Measures

Primary Outcomes (3)

• Change in the weekly mean subjective pain index after 21 days of treatment

  Weekly mean subjective pain computed as the arithmetic mean of daily pain subjective values (visual analog scale - VAS) in Visit 1and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") for the different muscular sites tested.

  Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)

• Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment

  Weekly mean pressure pain threshold is computed as the arithmetic mean of daily pressure pain threshold values for muscular sites in Visit 1and prior to each study visit. Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

  Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)

• Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment

  Weekly mean pressure pain tolerance is computed as the arithmetic mean of daily pressure pain tolerance values for muscular sites in Visit 1and prior to each study visit. Plot is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied per anatomical muscle site.

  Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)

Secondary Outcomes (13)

• Change in pressure pain threshold at temporalis muscle after 1 week of treatment

  Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)

• Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment

  Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)

• Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment

  Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)

• Change in pressure pain threshold at masseter muscle after 1 week of treatment

  Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)

• Change in pressure pain threshold at masseter muscle after 2 weeks of treatment

  Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)

Study Arms (3)

Isometric exercise Group

EXPERIMENTAL

Group of participants which perform Isometric mandibular exercises, once a day, for 21 days

Other: Isometric mandibular exercises

Isotonic exercise Group

ACTIVE COMPARATOR

Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days

Other: Isotonic mandibular exercises

Counseling Group

PLACEBO COMPARATOR

Group of participants which receive education brochure and no further interventions.

Behavioral: Counseling group

Interventions

Isometric mandibular exercises OTHER

daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars

Isometric exercise Group

Isotonic mandibular exercises OTHER

daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors

Isotonic exercise Group

Counseling group BEHAVIORAL

subjects included in this group get an education brochure about the disorder and receive no further interventions

Counseling Group

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Temporomandibular Myofascial pain diagnosis
• Oral contraceptives consumption
• Facial pain for at least 3 months (and at least 10 of the last 30 days at Visit 0)
• Agrees to terms for continuing/discontinuing certain prescription/over-the-counter pain medications.

You may not qualify if:

• Other orofacial pain diagnosis
• Oral surgery within 6 months
• Treatment for pain management within past 30 days
• Neurological or psychiatric disorders
• Orthodontic treatment
• History of pregnancy, pregnancy or breastfeeding.

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Musculoskeletal Pain; Facial Pain; Mandibular Diseases; Muscular Diseases; Contraception Behavior; Chronic Pain; Craniomandibular Disorders

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Reproductive Behavior; Behavior

Study Officials

• Juan F Oyarzo, Prof

  Universidad Andres Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orofacial Pain & TMD Professor

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 13, 2017
• Study Start: October 18, 2014
• Primary Completion: December 6, 2016
• Study Completion: December 30, 2016
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share