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

Temporomandibular Joint Dysfunction Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409874
• Other study ID #: AAMT16
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2020
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study is attempting to find out if one treatment strategy is more effective than the other.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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
• 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.
• Interocclusal Appliance
Interocclusal appliance worn every nights for 4 weeks.

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

Locations

Country	Name	City	State
Greece	Physiomed-lab	Thessaloníki

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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