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

NCT ID: NCT03409874

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Temporomandibular Joint Dysfunction Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dry Needling and Spinal Manipulation

Group Type EXPERIMENTAL

Dry Needling

Intervention Type 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

Intervention Type 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, NSAIDs and TMJ Mobs

Group Type ACTIVE_COMPARATOR

Interocclusal Appliance

Intervention Type OTHER

Interocclusal appliance worn every nights for 4 weeks.

NSAIDs

Intervention Type 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.

TMJ Mobs

Intervention Type OTHER

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

Interventions

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Dry Needling

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

Intervention Type 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.

Intervention Type OTHER

Interocclusal Appliance

Interocclusal appliance worn every nights for 4 weeks.

Intervention Type OTHER

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.

Intervention Type DRUG

TMJ Mobs

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

Intervention Type OTHER

Other Intervention Names

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splint diclofenac Voltaren

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

Alabama Physical Therapy & Acupuncture

OTHER

Sponsor Role lead

Responsible Party

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James Dunning, DPT, MSc, FAAOMPT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Dunning, DPT

Role: PRINCIPAL_INVESTIGATOR

American Academy of Manipulative Therapy

Locations

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Physiomed-lab

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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AAMT16

Identifier Type: -

Identifier Source: org_study_id