Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Ulnar Wrist Pain
• Intervention / Treatment: Other: Usual Care; Procedure: Dextrose

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Slullitel, M.D.; Phone Number: 0054 9 341 5012223; Email: mslullitel@gmail.com
• Study Contact Backup: Name: Ezequiel Mailand, M.D.; Phone Number: 005493416393318; Email: ezmailand@gmail.com

Study Locations

• Argentina
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Recruiting
      • Scanner Centro de Diagnostico
      • Contact: Ezequiel Mailand, MD; Phone Number: 005493416393318; Email: ezmailand@gmail.com
      • Contact: Miguel SLULLITEL, MD PHD; Phone Number: 00549341012211; Email: mslullitel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Abierta Interamericana
• Collaborators: Gonzaolo Yaumauchi, M.D.
• Investigators: Principal Investigator: Miguel Slullitel, M.D., Universidad Abierta Interamericana

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: chronic pain; sprain; wrist; tendinopathy
• Other Study ID Numbers: UniversidadAI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Anticipate sharing data by request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No