Clinical trial NCT03411811: Ulnar Wrist Pain Treatment With Dextrose Prolotherapy
Official title: Dextrose Prolotherapy in Chronic Ulnar Wrist Pain Resistant to Usual Care: Comparison to a Naive-to-treatment Cohort Who Receive Usual Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulnar Wrist Pain
Keywords: tendinopathy
wrist
chronic pain
sprain
Lead sponsor: Universidad Abierta Interamericana
Sponsor class: OTHER
Collaborators: name: Gonzaolo Yaumauchi, M.D.
First posted: 2018-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline PRWE (Patient Rated Wrist Evaluation) at 9 weeks
timeFrame: 9 weeks
measure: Change from baseline PRWE between 0 weeks and 1 year
timeFrame: 1 year
measure: Percentage of participants exceeding a PRWE change of plus 14 between baseline and 9 weeks
timeFrame: 9 weeks
measure: Percentage of participants exceeding a PRWE change of plus 14 between baseline and 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Satisfaction score at 9 weeks
timeFrame: 9 weeks
measure: Satisfaction score at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Scanner Centro de Diagnostico
state: Santa Fe
Study officials:
affiliation: Universidad Abierta Interamericana
name: Miguel Slullitel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jhsa.2007.01.022.
citation: 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.
citation: 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.