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Status unknownNCT03411811Updated May 4, 2021

Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

An interventional study of Usual Care and Dextrose in Ulnar Wrist Pain, sponsored by Universidad Abierta Interamericana. Status unknown at 1 site in Argentina. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by Universidad Abierta Interamericana · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulnar Wrist Pain

Keywords

  • tendinopathy
  • wrist
  • chronic pain
  • sprain
03

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pain on the ulnar side of the wrist.
  • PRWE greater than 40

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Usual Care

    Other: Usual Care

  • Experimental
    Dextrose

    Procedure: Dextrose

Interventions

  • OtherUsual Care

    Therapeutic ultrasound, myofascial release of extensor and flexor muscles of forearm and stabilization exercises for the wrist.

  • ProcedureDextrose

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 weeks

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

    Time frame: 1 year

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

    Time frame: 9 weeks

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

    Time frame: 1 year

Secondary outcomes

  1. 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'.

    Time frame: 9 weeks

  2. 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'

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Scanner Centro de Diagnostico
    Rosario, Santa Fe 2000, Argentina
    Recruiting
07

References and documents

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. PubMed 17398352 ↗
  • 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. PubMed 24549807 ↗
  • 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. PubMed 27788902 ↗

Individual participant data

Plan to share: Undecided — Anticipate sharing data by request

08

Registry details

Key details

Study ID
NCT03411811
Lead sponsor
Universidad Abierta Interamericana
Collaborators
Gonzaolo Yaumauchi, M.D.
Responsible party
Ezequiel Mailand and Miguel Slullitel (Ezequiel Mailand, M.D., Principal Investigator., Universidad Abierta Interamericana) — Principal investigator
First posted
Jan 26, 2018
Start date
Oct 1, 2018
Primary completion
Jan 2022 (estimated)
Completion
Jan 2023 (estimated)
Last update
May 4, 2021

Study contacts

Miguel Slullitel, M.D.
Contact
mslullitel@gmail.com
0054 9 341 5012223
Ezequiel Mailand, M.D.
Contact
ezmailand@gmail.com
005493416393318
Miguel Slullitel, M.D.
principal investigator · Universidad Abierta Interamericana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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