Ulnar Wrist Pain Clinical Trial
Official title:
Dextrose Prolotherapy in Chronic Ulnar Wrist Pain Resistant to Usual Care: Comparison to a Naive-to-treatment Cohort Who Receive Usual Care
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | January 2023 |
| Est. primary completion date | January 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 70 Years |
| Eligibility | Inclusion criteria - Pain on the ulnar side of the wrist. - PRWE greater than 40 Exclusion criteria - Radioulnar instability more than moderate as determined by a positive ulna fovea sign or ulna grinding test - Surgery in the wrist area - Infection in the wrist area - Other wrist pathology on examination - Other pain area that is constant, interferes with sleep, or is as bad, or worse, than shoulder pain. - Diabetes or other peripheral neuropathy - Radiculopathy - Unstable psychiatric function. - Current opioid use. - Vulnerable patients - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Scanner Centro de Diagnostico | Rosario | Santa Fe |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Abierta Interamericana | Gonzaolo Yaumauchi, M.D. |
Argentina,
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. Review. — View Citation
Spies CK, Müller 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. Review. German. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Change from baseline PRWE between 0 weeks and 1 year | 1 year | ||
| Primary | Percentage of participants exceeding a PRWE change of plus 14 between baseline and 9 weeks | 9 weeks | ||
| Primary | Percentage of participants exceeding a PRWE change of plus 14 between baseline and 1 year | 1 year | ||
| Secondary | 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 | |
| Secondary | Satisfaction score at 1 year | On a scale from 1-5 please rate satisfaction with your results. 1 means 'no satisfaction' and 5 means 'complete satisfaction' | 1 year |