An interventional study of Dry Needling and Spinal manipulation in Temporomandibular Joint Dysfunction Syndrome, sponsored by Alabama Physical Therapy & Acupuncture. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment
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.
54 studies on the registry are indexed under Temporomandibular Joint Dysfunction Syndrome; 14 are open to participants now.
This study's enrollment of 120 is above the median of 49 across 43 interventional studies indexed under Temporomandibular Joint Dysfunction Syndrome.
Browse Temporomandibular Joint Dysfunction Syndrome studies →Alabama Physical Therapy & Acupuncture is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient presents with the following: (Gonzalez Perez et al., 2015)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Dry Needling · Other: Spinal manipulation
Other: Interocclusal Appliance · Drug: NSAIDs · Other: TMJ Mobs
Dry needling to the muscle of mastication and temporomandibular joint capsule. 1-2 treatment sessions per week for up to 4 weeks
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 worn every nights for 4 weeks.
Also known as: 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.
Also known as: diclofenac, Voltaren
Temporomandibular joint mobilization targeting the temporomandibular joint capsule. 1-2 treatments per week for up to 4 weeks.
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.
Time frame: baseline, 2 weeks, 6 weeks, 3 months
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).
Time frame: 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.
Time frame: baseline, 2 weeks, 6 weeks, 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jul 2020, 29 months.
Of 24 interventional studies with no phase under Temporomandibular Joint Dysfunction Syndrome, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 29 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Dysfunction Syndrome →
Alabama Physical Therapy & Acupuncture