Ulnar Wrist PainNCT03411811
Ulnar Wrist Pain Treatment With Dextrose Prolotherapy
A study testing Dextrose in people with Ulnar Wrist Pain, run by Universidad Abierta Interamericana at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Ulnar Wrist Pain
- What is being tested?
- Dextrose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2018to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain on the ulnar side of the wrist.
- PRWE greater than 40
Who cannot join
- 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
Show all 11Show fewer
- Radiculopathy
- Unstable psychiatric function.
- Current opioid use.
- Vulnerable patients
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Scanner Centro de Diagnostico
Rosario, Santa Fe Province, 2000
Ezequiel Mailand, MD, 005493416393318, ezmailand@gmail.com
Miguel SLULLITEL, MD PHD, 00549341012211, mslullitel@gmail.com
About this study
Official title: 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.
- Conditions
- Ulnar Wrist Pain
- Being tested
- Usual Care, Dextrose
- Keywords
- tendinopathy, wrist, chronic pain, sprain
- Medical subject headings
- Tendinopathy, Chronic Pain, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Therapeutic ultrasound, myofascial release of extensor and flexor muscles of forearm and stabilization exercises for the wrist.
DextroseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Not described Receives: Other: Usual Care |
| Dextrose | Experimental | Not described Receives: Procedure: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Change from baseline PRWE between 0 weeks and 1 year
Measured: 1 year
Percentage of participants exceeding a PRWE change of plus 14 between baseline and 9 weeks
Measured: 9 weeks
Percentage of participants exceeding a PRWE change of plus 14 between baseline and 1 year
Measured: 1 year
Secondary outcomes (2)
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'.
Measured: 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'
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Oct 2018
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulnar Wrist PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Abierta Interamericana
- Sponsor type
- University, hospital or other
- Collaborators
- Gonzaolo Yaumauchi, M.D.
- Responsible party
- Principal investigator, Ezequiel Mailand and Miguel Slullitel, Universidad Abierta Interamericana
- Investigators
- Miguel Slullitel, M.D., Principal investigator, Universidad Abierta Interamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411811
- Sponsor's protocol ID
- UniversidadAI
- Status last verified
- May 2021
- First submitted
- 3 Jan 2018
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anticipate sharing data by request
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 17398352Spies 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 24549807Reeves 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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextrose Prolotherapy in Chronic Ulnar Wrist Pain Resistant to Usual Care: Comparison to a Naive-to-treatment Cohort Who Receive Usual Care
- ClinicalTrials.gov ID
- NCT03411811
- Acronym / sponsor ID
- UniversidadAI
- Conditions
- Ulnar Wrist Pain
- Keywords
- tendinopathy, wrist, chronic pain, sprain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Abierta InteramericanaUniversity, hospital or other
- Collaborators
- Gonzaolo Yaumauchi, M.D.
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual Care |
| Dextrose | Experimental | Procedure: Dextrose |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain on the ulnar side of the wrist.
- PRWE greater than 40
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareTherapeutic ultrasound, myofascial release of extensor and flexor muscles of forearm and stabilization exercises for the wrist. | Other | Usual Care |
| DextroseInjection 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. | Procedure or surgery | Dextrose |
Primary outcome
Change from Baseline PRWE (Patient Rated Wrist Evaluation) at 9 weeks
Time frame: 9 weeks
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.
Change from baseline PRWE between 0 weeks and 1 year
Time frame: 1 year
Percentage of participants exceeding a PRWE change of plus 14 between baseline and 9 weeks
Time frame: 9 weeks
Percentage of participants exceeding a PRWE change of plus 14 between baseline and 1 year
Time frame: 1 year
2 secondary outcomes
Satisfaction score at 9 weeks
Time frame: 9 weeks
Satisfaction score at 1 year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 17398352Tay 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.
- Background: PubMed 24549807Spies 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.
- Background: PubMed 27788902Reeves 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.
- Individual participant dataSharing planned: Undecided. Anticipate sharing data by request
Related trials for Ulnar Wrist Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Slullitel, M.D. principal investigator
Universidad Abierta Interamericana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose in people with Ulnar Wrist Pain, run by Universidad Abierta Interamericana at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Slullitel, M.D. (0054 9 341 5012223, mslullitel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline PRWE (Patient Rated Wrist Evaluation) at 9 weeks (time frame: 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411811, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.