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| Name | Class |
|---|---|
| Gonzaolo Yaumauchi, M.D. | UNKNOWN |
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Participants who have failed therapy for chronic wrist pain on the little finger side of the wrist will recieve dextrose prolotherapy. Their results will be compared to a cohort of consecutive participants who have not failed therapy, and receive 4 weeks of usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator |
| |
| Dextrose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | Therapeutic ultrasound, myofascial release of extensor and flexor muscles of forearm and stabilization exercises for the wrist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline PRWE (Patient Rated Wrist Evaluation) at 9 weeks | The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. | 9 weeks |
| Change from baseline PRWE between 0 weeks and 1 year | 1 year | |
| Percentage of participants exceeding a PRWE change of plus 14 between baseline and 9 weeks | 9 weeks | |
| Percentage of participants exceeding a PRWE change of plus 14 between baseline and 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction score at 9 weeks | On a scale from 1-5 please rate satisfaction with your results. 1 means 'no satisfaction' and 5 means 'complete satisfaction'. | 9 weeks |
| Satisfaction score at 1 year |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Slullitel, M.D. | Contact | 0054 9 341 5012223 | mslullitel@gmail.com | |
| Ezequiel Mailand, M.D. | Contact | 005493416393318 | ezmailand@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Slullitel, M.D. | Universidad Abierta Interamericana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scanner Centro de Diagnostico | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17398352 | Background | Tay SC, Tomita K, Berger RA. The "ulnar fovea sign" for defining ulnar wrist pain: an analysis of sensitivity and specificity. J Hand Surg Am. 2007 Apr;32(4):438-44. doi: 10.1016/j.jhsa.2007.01.022. | |
| 24549807 | Background | Spies CK, Muller LP, Oppermann J, Hahn P, Unglaub F. [Instability of the distal radioulnar joint - an overview of clinical and radiological procedures regarding their efficacies]. Handchir Mikrochir Plast Chir. 2014 Jun;46(3):137-50. doi: 10.1055/s-0033-1363662. Epub 2014 Feb 18. German. |
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Anticipate sharing data by request
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D059350 | Chronic Pain |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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Participants are assigned to one of two groups in parallel. After that the study becomes one arm as both groups are offered dextrose.
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| Dextrose | Procedure | Injection of 1 ml of 12.5% dextrose in 1% lidocaine at 0, 3 and 6 weeks in 5 locations: Origin of ulnar collateral ligament, insertion of ulnar collateral ligament on the triquetrum, insertion of the extensor carpi ulnaris on the base of the 5th metacarpal, triquetral hamate ligament and ulnotriquetral joint space. |
|
On a scale from 1-5 please rate satisfaction with your results. 1 means 'no satisfaction' and 5 means 'complete satisfaction'
| 1 year |
| 27788902 | Background | Reeves KD, Sit RW, Rabago DP. Dextrose Prolotherapy: A Narrative Review of Basic Science, Clinical Research, and Best Treatment Recommendations. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):783-823. doi: 10.1016/j.pmr.2016.06.001. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |