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

NCT03409874 | Completed

• 1 other identifier: AAMT16
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Outcome Measures

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.

  baseline, 2 weeks, 6 weeks, 3 months

Secondary Outcomes (2)

• Global Rating of Perceived Change

  2 weeks, 6 weeks, 3 months

• Active Pain Free Mouth Opening

  baseline, 2 weeks, 6 weeks, 3 months

Study Arms (2)

Dry Needling and Spinal Manipulation

EXPERIMENTAL

Other: Dry Needling; Other: Spinal manipulation

Interocclusal Appliance, NSAIDs and TMJ Mobs

ACTIVE COMPARATOR

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

Interventions

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

Dry Needling and Spinal Manipulation

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.

Dry Needling and Spinal Manipulation

Interocclusal Appliance OTHER

Interocclusal appliance worn every nights for 4 weeks.

Also known as: splint

Interocclusal Appliance, NSAIDs and TMJ Mobs

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.

Also known as: diclofenac, Voltaren

Interocclusal Appliance, NSAIDs and TMJ Mobs

TMJ Mobs OTHER

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

Interocclusal Appliance, NSAIDs and TMJ Mobs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Physiomed-lab

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

Dry Needling; Manipulation, Spinal; Splints; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Rehabilitation; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• James Dunning, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 24, 2018
• Study Start: February 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

GR (1)