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| Name | Class |
|---|---|
| Universidad Rey Juan Carlos | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Needling and Spinal Manipulation | Experimental |
| |
| Interocclusal Appliance, NSAIDs and TMJ Mobs | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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:
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). |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Dunning, DPT | American Academy of Manipulative Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiomed-lab | Thessaloniki | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35412448 | Derived | Dunning J, Butts R, Bliton P, Vathrakokoilis K, Smith G, Lineberger C, Eshleman N, Fernandez-de-Las-Penas C, Young IA. Dry needling and upper cervical spinal manipulation in patients with temporomandibular disorder: A multi-center randomized clinical trial. Cranio. 2024 Nov;42(6):809-822. doi: 10.1080/08869634.2022.2062137. Epub 2022 Apr 12. |
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| 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. |
|
| Interocclusal Appliance | Other | Interocclusal appliance worn every nights for 4 weeks. |
|
|
| 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. |
|
|
| TMJ Mobs | Other | Temporomandibular joint mobilization targeting the temporomandibular joint capsule. 1-2 treatments per week for up to 4 weeks. |
|
| 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 |
| ID | Term |
|---|---|
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009209 | Myofascial Pain Syndromes |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| D020393 | Manipulation, Spinal |
| D013165 | Splints |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |
| D012046 | Rehabilitation |
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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