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Temporomandibular Joint Dysfunction SyndromeNCT03409874

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

A study testing Dry Needling, Spinal manipulation and Interocclusal Appliance in people with Temporomandibular Joint Dysfunction Syndrome, run by Alabama Physical Therapy & Acupuncture at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dry Needling, Spinal manipulation and Interocclusal Appliance
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGreece
Study dates
1 Feb 2018to 1 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Physiomed-lab

    Thessaloniki

Other trials in Greece

About this study

Official title: Dry Needling and Spinal Manipulation or 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.

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.

Being tested
Dry Needling, Spinal manipulation, Interocclusal Appliance, NSAIDs, TMJ Mobs
Medical subject headings
Temporomandibular Joint Dysfunction Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry NeedlingOther

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

  • Spinal manipulationOther

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

  • Interocclusal ApplianceOther

    Also called splint

    Interocclusal appliance worn every nights for 4 weeks.

  • NSAIDsDrug

    Also called diclofenac, Voltaren

    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.

  • TMJ MobsOther

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

Study groups in NCT03409874
Study groupRoleWhat they receive
Dry Needling and Spinal ManipulationExperimentalNot described
Receives: Other: Dry Needling; Other: Spinal manipulation
Interocclusal Appliance, NSAIDs and TMJ MobsActive comparatorNot described
Receives: Other: Interocclusal Appliance; Drug: NSAIDs; Other: TMJ Mobs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, 2 weeks, 6 weeks, 3 months

Secondary outcomes (2)

  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).

    Measured: 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.

    Measured: baseline, 2 weeks, 6 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2018
  2. Study start1 Feb 2018
  3. Primary completion1 Jul 2020
  4. Study completion1 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03409874
Sponsor's protocol ID
AAMT16
Status last verified
Dec 2020
First submitted
10 Jan 2018
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dunning J, Butts R, Bliton P, Vathrakokoilis K, Smith G, Lineberger C, Eshleman N, Fernandez-de-Las-Penas C, Young IA. Dry needling and upper cervical spinal manipulation in patients with temporomandibular disorder: A multi-center randomized clinical trial. Cranio. 2024 Nov;42(6):809-822. doi: 10.1080/08869634.2022.2062137. Epub 2022 Apr 12.

    PubMed 35412448

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling, Spinal manipulation and Interocclusal Appliance in people with Temporomandibular Joint Dysfunction Syndrome, run by Alabama Physical Therapy & Acupuncture at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: baseline, 2 weeks, 6 weeks, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03409874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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