Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

• Sponsor: Universidad Abierta Interamericana (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03411811
• Collaborator: Gonzaolo Yaumauchi, M.D. (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulnar Wrist Pain	Other: Usual Care; Procedure: Dextrose	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Treatment
• Official Title: Dextrose Prolotherapy in Chronic Ulnar Wrist Pain Resistant to Usual Care: Comparison to a Naive-to-treatment Cohort Who Receive Usual Care
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change from Baseline PRWE (Patient Rated Wrist Evaluation) at 9 weeks [9 weeks]

   The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

2. Change from baseline PRWE between 0 weeks and 1 year [1 year]

3. Percentage of participants exceeding a PRWE change of plus 14 between baseline and 9 weeks [9 weeks]

4. Percentage of participants exceeding a PRWE change of plus 14 between baseline and 1 year [1 year]

Secondary Outcome Measures

1. Satisfaction score at 9 weeks [9 weeks]

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

2. Satisfaction score at 1 year [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scanner Centro de Diagnostico	Rosario	Santa Fe	Argentina	2000

Sponsors and Collaborators

• Universidad Abierta Interamericana
• Gonzaolo Yaumauchi, M.D.

Investigators

• Principal Investigator: Miguel Slullitel, M.D., Universidad Abierta Interamericana

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Ezequiel Mailand and Miguel Slullitel, Ezequiel Mailand, M.D., Principal Investigator., Universidad Abierta Interamericana
• ClinicalTrials.gov Identifier: NCT03411811
• Other Study ID Numbers: UniversidadAI
• First Posted: Jan 26, 2018
• Last Update Posted: May 4, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ezequiel Mailand and Miguel Slullitel, Ezequiel Mailand, M.D., Principal Investigator., Universidad Abierta Interamericana: tendinopathy; wrist; chronic pain; sprain

Study Results

No Results Posted as of May 4, 2021