Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

NCT ID: NCT03411811

Last Updated: 2021-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulnar Wrist Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of two groups in parallel. After that the study becomes one arm as both groups are offered dextrose.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Dextrose

Group Type EXPERIMENTAL

Dextrose

Intervention Type PROCEDURE

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.

Interventions

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Usual Care

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

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gonzaolo Yaumauchi, M.D.

UNKNOWN

Sponsor Role collaborator

Universidad Abierta Interamericana

OTHER

Sponsor Role lead

Responsible Party

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Ezequiel Mailand and Miguel Slullitel

Ezequiel Mailand, M.D., Principal Investigator.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel Slullitel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Abierta Interamericana

Locations

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Scanner Centro de Diagnostico

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Miguel Slullitel, M.D.

Role: CONTACT

0054 9 341 5012223

Ezequiel Mailand, M.D.

Role: CONTACT

005493416393318

Facility Contacts

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Ezequiel Mailand, MD

Role: primary

005493416393318

Miguel SLULLITEL, MD PHD

Role: backup

00549341012211

References

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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.

Reference Type BACKGROUND
PMID: 17398352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24549807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27788902 (View on PubMed)

Other Identifiers

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UniversidadAI

Identifier Type: -

Identifier Source: org_study_id

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