Clinical trial NCT03409874: Dry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
Official title: Dry Needling and Spinal Manipulation or Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2018-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline, 2 weeks, 6 weeks, 3 months
Secondary outcomes:
measure: Global Rating of Perceived Change
timeFrame: 2 weeks, 6 weeks, 3 months
measure: Active Pain Free Mouth Opening
timeFrame: baseline, 2 weeks, 6 weeks, 3 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Physiomed-lab
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT
role: PRINCIPAL_INVESTIGATOR
References: