NCT03411811

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

3.3 years

First QC Date

January 3, 2018

Last Update Submit

May 2, 2021

Conditions

Ulnar Wrist Pain

Keywords

tendinopathywristchronic painsprain

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Satisfaction score at 9 weeks

    9 weeks

  • Satisfaction score at 1 year

    1 year

Study Arms (2)

Usual Care

ACTIVE COMPARATOR
Other: Usual Care

Dextrose

EXPERIMENTAL
Procedure: Dextrose

Interventions

Usual CareOTHER

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

Usual Care
DextrosePROCEDURE

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.

Dextrose

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scanner Centro de Diagnostico

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Related Publications (3)

  • 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.

    PMID: 17398352BACKGROUND

  • 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.

    PMID: 24549807BACKGROUND

  • 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.

    PMID: 27788902BACKGROUND

MeSH Terms

Conditions

TendinopathyChronic PainSprains and Strains

Interventions

Glucose

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Miguel Slullitel, M.D.

    Universidad Abierta Interamericana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Slullitel, M.D.

CONTACT

0054 9 341 5012223mslullitel@gmail.com

Ezequiel Mailand, M.D.

CONTACT

005493416393318ezmailand@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two groups in parallel. After that the study becomes one arm as both groups are offered dextrose.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ezequiel Mailand, M.D., Principal Investigator.

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 26, 2018

Study Start

October 1, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

AR(1)