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CompletedNCT03409874Updated Dec 29, 2020

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

An interventional study of Dry Needling and Spinal manipulation in Temporomandibular Joint Dysfunction Syndrome, sponsored by Alabama Physical Therapy & Acupuncture. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-29.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Dry Needling and Spinal Manipulation

    Other: Dry Needling · Other: Spinal manipulation

  • Active comparator
    Interocclusal Appliance, NSAIDs and TMJ Mobs

    Other: Interocclusal Appliance · Drug: NSAIDs · Other: TMJ Mobs

Interventions

  • OtherDry Needling

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

  • OtherSpinal manipulation

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

  • OtherInterocclusal Appliance

    Interocclusal appliance worn every nights for 4 weeks.

    Also known as: splint

  • DrugNSAIDs

    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.

    Also known as: diclofenac, Voltaren

  • OtherTMJ Mobs

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

05

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    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.

    Time frame: baseline, 2 weeks, 6 weeks, 3 months

Secondary outcomes

  1. Global Rating of Perceived Change

    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).

    Time frame: 2 weeks, 6 weeks, 3 months

  2. Active Pain Free Mouth Opening

    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.

    Time frame: baseline, 2 weeks, 6 weeks, 3 months

06

Study locations

1 site
  • Physiomed-lab
    Thessaloníki, Greece
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409874
Lead sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
Responsible party
James Dunning, DPT, MSc, FAAOMPT (Principal Investigator, Alabama Physical Therapy & Acupuncture) — Principal investigator
First posted
Jan 24, 2018
Start date
Feb 1, 2018
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020
Last update
Dec 29, 2020

Study contacts

James Dunning, DPT
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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