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NCT Number: NCT03339739

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

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.

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Key information

Conditions

Temporomandibular Disorders Behavior Chronic Pain Contraception Behavior Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Reproductive Behavior Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Temporomandibular disorders (TMDs) represent heterogeneous musculoskeletal disorders, where most common presentation is mandibular muscle pain, which is also more common among female than men. Many interventions have been proposed for this pain control, regarding drugs, oral splints, relaxing exercises and self awareness but little is known about mandibular active contraction exercises. The aim of this study is to evaluate the effects of mandibular exercises in pain perception and sensitivity in women. A double blind randomized clinical trial will be conducted among fertile university student women with Oral Contraceptives (OC) use -to control hormonal influences-, with report of facial pain and myofascial pain diagnosis (RDC/TMD). They will be assessed in Visual analogue scale (VAS), sleep quality, Pressure Pain Threshold (PPT) and pressure pain tolerance (PPTol), and then allocated in one of the three interventions for 21 days: isometric mandibular active exercises over silicone bars; video-guided isotonic mandibular contractions over cloth pegs or counseling about disorders nature as passive comparison. After 21 days, VAS, PPT and PPTol in bilateral temporalis and masseter muscles will be assessed for a second time,) and compared with initial pain status.

Data will be entered by single blind operator, and will be open for quality auditing. Site monitoring will be performed by the University clinical entities.

Data checks will be also performed as planned. Descriptive and analytical statistics will be performed to address the primary and secondary objectives.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Counseling group

Behavioral

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

Primary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

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

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

    Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

  6. Change in pressure pain threshold at masseter muscle after 3 weeks of treatment

    Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)

    Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of t masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

  7. Change in pressure pain tolerance at temporalis muscle after 1 week of treatment

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

    Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.

  8. Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment

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

    Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.

  9. Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment

    Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)

    Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.

  10. Change in pressure pain tolerance at masseter muscle after 1 week of treatment

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

    Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.

  11. Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment

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

    Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.

  12. Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment

    Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)

    Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.

  13. Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment

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

    The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale. The 7 component scores are summed to obtain a global score, which has a range of 0-21.

Sponsors and collaborators

Lead sponsor

Universidad Nacional Andres Bello

Other

Registry information

Official study title

Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2017
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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