Dry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction
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|ClinicalTrials.gov Identifier: NCT03409874|
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Dysfunction Syndrome||Other: Dry Needling Other: Spinal manipulation Other: Interocclusal Appliance Drug: NSAIDs Other: TMJ Mobs||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Dry Needling and Spinal Manipulation or Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular Dysfunction|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||February 1, 2020|
|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 Name: splint
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.
- Visual Analogue Scale [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
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.
- Global Rating of Perceived Change [ Time Frame: 2 weeks, 6 weeks, 3 months ]
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).
- Active Pain Free Mouth Opening [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409874
|Contact: James Dunning, DPTfirstname.lastname@example.org|
|Contact: Raymond Butts, DPTemail@example.com|
|Principal Investigator:||James Dunning, DPT||American Academy of Manipulative Therapy|