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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Dysfunction Syndrome
• Intervention / Treatment: Other: Dry Needling; Other: Spinal manipulation; Other: Interocclusal Appliance; Drug: NSAIDs; Other: TMJ Mobs

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece
    • Physiomed-lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dry Needling and Spinal Manipulation	Other: Dry Needling; Dry needling to the muscle of mastication and temporomandibular joint capsule. 1-2 treatment sessions per week for up to 4 weeks; 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.
ACTIVE_COMPARATOR: Interocclusal Appliance, NSAIDs and TMJ Mobs	Other: Interocclusal Appliance; Interocclusal appliance worn every nights for 4 weeks.; Other Names: splint; Drug: 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.; Other Names: Voltaren; diclofenac; Other: TMJ Mobs; Temporomandibular joint mobilization targeting the temporomandibular joint capsule. 1-2 treatments per week for up to 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks, 6 weeks, 3 months
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.	baseline, 2 weeks, 6 weeks, 3 months

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (ACTUAL): January 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: AAMT16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No