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| Name | Class |
|---|---|
| Zarate, Miguel, M.D. | INDIV |
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Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has be notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with saline injection for temporomandibular(jaw) dysfunction, also known as TMD.
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intraarticular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextrose Injection | Active Comparator |
| |
| Sterile Water Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of 20% dextrose/ 0.2% lidocaine | Other | Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain | Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale. | 3 months |
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 3 months | Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome. | 3 months |
| Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction. | Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale. | 3 months |
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 3 months | Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome. | 3 months |
| Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain | Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale. | 1 year |
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 1 year | Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite. | An increase in mouth opening in millimeters is considered an improvement in this study. | 3 months |
| Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo D Frusso, M.D. | Hospital Italiano de Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1181 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32780636 | Derived | Zarate MA, Frusso RD, Reeves KD, Cheng AL, Rabago D. Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial. J Altern Complement Med. 2020 Nov;26(11):1064-1073. doi: 10.1089/acm.2020.0207. Epub 2020 Aug 11. |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D000083 |
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| Injection of 1 ml of 0.8 SW/0.2% lidocaine | Other | Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine. |
|
| Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction |
Anchors include "0 = no pain" and "10 = worst pain imaginable" An improvement is a reduction in the NRS scale. |
| 1 year |
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 1 year | Anchors include "0 = no pain" and "10 = worst pain imaginable." A 50% reduction in the 0-10 NRS is a clinically important outcome. | 1 year |
Anchors include "0 = no satisfaction" and "10 = complete satisfaction" |
| 3 months |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |