Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Dextrose Prolotherapy in Chronic Ulnar Wrist Pain Resistant to Usual Care: Comparison to a Naive-to-treatment Cohort Who Receive Usual Care

Conditions
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Ulnar Wrist Pain

Intervention / Treatment
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* Other: Usual Care
* Procedure: Dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel. After that the study becomes one arm as both groups are offered dextrose.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br> | Other: Usual Care<br>* Therapeutic ultrasound, myofascial release of extensor and flexor muscles of forearm and stabilization exercises for the wrist.<br>|
| Experimental: Dextrose<br> | Procedure: Dextrose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | On a scale from 1-5 please rate satisfaction with your results. 1 means 'no satisfaction' and 5 means 'complete satisfaction' | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrist, tendinopathy, chronic pain, sprain