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Completed

NCT Number: NCT03409874

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiomed-lab

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients at least 18 years old
  • 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.
  • History of symptoms related to TMD for at least 3 months
  • 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)
  • Patient presents with the following: (Gonzalez Perez et al., 2015)
  • Strong pain in the anterior part of the lower belly of the LPM on palpation
  • Deep-seated pain in the TMJ and/or region of the maxillary sinus (referred pain)
  • 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

  • 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.
  • 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
  • History of traumatic injury such as a fracture or whiplash
  • Concomitant diagnosis of any primary headache (i.e. tension type headache or Migraine) except cervicogenic headaches
  • History of surgery related to TMD
  • Diagnosis of fibromyalgia
  • Systemic disease such as RA, lupus erythematosus or psoriatic arthritis
  • Presence of neurological disorder such as trigeminal neuralgia
  • History of PT, acupuncture or splint treatment within 3 months of the study
  • History of taking prescription NSAIDs within 3 months of the study
  • History of regularly taking non-prescription NSAIDs (i.e. more than intermittent) within 3 months of the study
  • Known sensitivity to acetylsalicylic acid, with impaired coagulation or with ulcer, kidney or liver problems.
  • Cadiac pacemaker, metal allergy or severe needle phobia
  • Serious cardiovascular, cerebral disease, psychiatric disorder or cognitive Impairment
  • Pregnancy

Treatment and study plan

dry needling

Other

Dry needling to the muscle of mastication and temporomandibular joint capsule. 1-2 treatment sessions per week for up to 4 weeks

Spinal Manipulation

Other

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

Interocclusal Appliance

Other

Interocclusal appliance worn every nights for 4 weeks.

Other names: splint

NSAIDs

Drug

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

TMJ Mobs

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2018
Registry last updated
Dec 29, 2020

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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