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Dry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction

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ClinicalTrials.gov Identifier: NCT03409874
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture

Brief Summary:
The purpose of this research is to compare two different approaches for treating patients with temporomandibular dysfunction (TMD): Dry needling and spinal manipulation or Interocclusal Appliance (Splint), NSAIDs and Temporomandibular Joint Mobilization . Clinicians commonly use all of these techniques to treat TMD. This study is attempting to find out if one treatment strategy is more effective than the other.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Dysfunction Syndrome Other: Dry Needling Other: Spinal manipulation Other: Interocclusal Appliance Drug: NSAIDs Other: TMJ Mobs Not Applicable

Detailed Description:
Patients with stress temporomandibular dysfunction will be randomized to receive 1-2 treatment sessions per week for up to 4 weeks ( up to 8 sessions total) of either: (1) dry needling and spinal manipulation or (2) Interocclusal appliance (splint), NSAIDs, temporomandibular joint mobilization.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry Needling and Spinal Manipulation or Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dry Needling and Spinal Manipulation Other: Dry Needling
Dry needling to the muscle of mastication and temporomandibular joint capsule. 1-2 treatment sessions per week for up to 4 weeks

Other: Spinal manipulation
Spinal manipulation, targeting the upper cervical spine (C1-C2, C2-C3 or OA). 1-2 treatments per week for up to 4 weeks.

Active Comparator: Interocclusal Appliance, NSAIDs and TMJ Mobs Other: Interocclusal Appliance
Interocclusal appliance worn every nights for 4 weeks.
Other Name: splint

Drug: NSAIDs
diclofenac (Voltaren) 3 X 50mg per day for 4 weeks. If the patient's TMJ pain improves, the dosage may be reduced to 2 X 50mg per day.
Other Names:
  • diclofenac
  • Voltaren

Other: TMJ Mobs
Temporomandibular joint mobilization targeting the temporomandibular joint capsule. 1-2 treatments per week for up to 4 weeks.




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]

    Change in average jaw pain intensity rated by the patient over last 24 hours and last 7 days (VAS: 0-100mm) between baseline and the following time points: 2 weeks, 6 weeks and 3 months.

    Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), the visual analogue score after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment). Scores closer to 0 represent less pain.



Secondary Outcome Measures :
  1. Global Rating of Perceived Change [ Time Frame: 2 weeks, 6 weeks, 3 months ]

    Global rating of perceived change rated rated by the patient according to a -7 to +7 scale. More specifically, the Global Rating of Perceived Change is rated as follows:

    • A very great deal worse (-7)
    • A great deal worse (-6)
    • Quite a bit worse (-5)
    • Moderately worse (-4)
    • Somewhat worse (-3)
    • A little bit worse (-2)
    • A tiny bit worse (almost the same) (-1)
    • About the same (0)
    • A very great deal better (+7)
    • A great deal better (+6)
    • Quite a bit better (+5)
    • Moderately better (+4)
    • Somewhat better (+3)
    • A little bit better (+2)
    • A tiny bit better (almost the same) (+1)

    The patient will choose a rating (the closer to +7, the better the score / the closer to -7, the worse the score) after 2 weeks of treatment, at 6 weeks (2 weeks post-treatment) and 3 months (2 months post-treatment).


  2. Active Pain Free Mouth Opening [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]

    Change in the distance between upper and lower central incisors after patient has opening mouth "as wide as possible" without causing pain between baseline and the following time points: 2 weeks, 6 weeks and 3 months. Measurements will be taken in mm. The greater the distance, the better the score.

    Even though patients will be treated 1-2 treatments per week for 4 weeks (up to 8 treatments total), active pain free mouth opening after 2 weeks of treatment, at 6 weeks (2 weeks post treatment) and at 3 months (2 months post treatment) will be compared to baseline (pre-treatment)

    Greater scores represent greater pain free mouth opening.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients at least 18 years old
  2. Patient referred to physical therapy from a physician or dentist with a diagnosis of temporomandibular dysfunction that is consistent with the Revised TMD Group 1 Muscle Disorders Diagnostic Algorithm. (Dworkin et al.1992; Look et al., 2010]. According to Blanco-Hungria et al. (2015), this category represents 88.7% of patients with TMD.
  3. History of symptoms related to TMD for at least 3 months
  4. Intensity of pain related to TMD at least 30mm out 100 per Visual Analogue scale (La Touche et al, 2009; Gonzalez-Ingesias et al., 2013)
  5. Patient presents with the following: (Gonzalez Perez et al., 2015)

    1. Strong pain in the anterior part of the lower belly of the LPM on palpation
    2. Deep-seated pain in the TMJ and/or region of the maxillary sinus (referred pain)
    3. Significant motor dysfunction (e.g. limited jaw opening, painful protrusion of the chin against resistance, mandibular lateralization to the opposite side upon opening).

Exclusion Criteria:

  1. Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
  2. Signs or symptoms of disc displacement, arthrosis or arthritis of the temporomandibular joint according to category II and III of the Research Diagnostic Criteria for Temporomandibular Disorders
  3. History of traumatic injury such as a fracture or whiplash
  4. Concomitant diagnosis of any primary headache (i.e. tension type headache or Migraine) except cervicogenic headaches
  5. History of surgery related to TMD
  6. Diagnosis of fibromyalgia
  7. Systemic disease such as RA, lupus erythematosus or psoriatic arthritis
  8. Presence of neurological disorder such as trigeminal neuralgia
  9. History of PT, acupuncture or splint treatment within 3 months of the study
  10. History of taking prescription NSAIDs within 3 months of the study
  11. History of regularly taking non-prescription NSAIDs (i.e. more than intermittent) within 3 months of the study
  12. Known sensitivity to acetylsalicylic acid, with impaired coagulation or with ulcer, kidney or liver problems.
  13. Cadiac pacemaker, metal allergy or severe needle phobia
  14. Serious cardiovascular, cerebral disease, psychiatric disorder or cognitive Impairment
  15. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409874


Contacts
Contact: James Dunning, DPT 801-707-9056 jamesdunning@hotmail.com
Contact: Raymond Butts, DPT 803-422-3954 fellowship@spinalmanipulation.org

Locations
Greece
Physiomed-lab Recruiting
Thessaloníki, Greece
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
Principal Investigator: James Dunning, DPT American Academy of Manipulative Therapy

Responsible Party: James Dunning, DPT, MSc, FAAOMPT, Principal Investigator, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier: NCT03409874     History of Changes
Other Study ID Numbers: AAMT16
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action