NCT04791202

Brief Summary

The evolving reports form recent studies are creating a promise on the potential use of dextrose injections for treating arthritis and replacing current method of treating early osteoarthritis by corticosteroids by giving long standing effect and improving patients' symptoms and function. Over the past 5 years, an increasing number of level I and level II studies have emerged, examining the effect of intra-articular prolotherapy for the treatment of both hip and knee osteoarthritis. On the contrary, there is limited data in small joints, such as the temporomandibular joint.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Apr 2021

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

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 8, 2021

Last Update Submit

March 12, 2021

Conditions

PainSatisfaction, PatientFunctionality

Outcome Measures

Primary Outcomes (2)

  • post-injection pain

    visual analog score for pain (0 for no pain, 10 for worst pain)

    1 day

  • post-injection functionality

    Q-DASH score for functionality (0 for no disability, 100 for most disability)

    1 day

Study Arms (2)

Dextrose Group

EXPERIMENTAL

Injection for Group A: A 27-gauge needle to be inserted in the 1st CMC joint, at which time 0.5 ml of 15% dextrose mixed with 0.5 ml of 1% lidocaine solution is injected into intra and peri-articular area.

Drug: Dextrose

Methylprednisolone Acetate Group

ACTIVE COMPARATOR

Injection for Group B: A 27-gauge needle to be inserted in the 1st CMC joint, at which time 0.5 ml of 40mg methylprednisolone acetate mixed with 0.5 ml of 1% lidocaine solution is injected into intra and peri-articular area.

Drug: Methylprednisolone Acetate 40 MG/ML

Interventions

DextroseDRUG

See arm descriptions

Dextrose Group
Methylprednisolone Acetate 40 MG/MLDRUG

See arm descriptions

Methylprednisolone Acetate Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those patients with diagnosis of carpometacarpal (CMC) osteoarthritis
  • Those patients who fit the age limits

You may not qualify if:

  • Those patients outside of the age limits
  • Those patients with systemic rheumatic disease, comorbid hand conditions (such as carpal tunnel syndrome or De Quervain's tenosynovitis), gout, pseudogout
  • Those patients with a predisposition to bleeding issues
  • Those patients with previous surgery to the affected thumb
  • Those patients with previous injection to the involved thumb base within the past 12 months
  • Those patients with severe X-ray osteoarthritis of grade IV (Eaton and Littler classification) and no evidence of CMC joint space narrowing on plain radiographs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Cook GS, Lalonde DH. MOC-PSSM CME article: Management of thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-9. doi: 10.1097/01.prs.0000294708.70340.8c.

    PMID: 18182958RESULT

  • Merritt MM, Roddey TS, Costello C, Olson S. Diagnostic value of clinical grind test for carpometacarpal osteoarthritis of the thumb. J Hand Ther. 2010 Jul-Sep;23(3):261-7; quiz 268. doi: 10.1016/j.jht.2010.02.001. Epub 2010 May 10.

    PMID: 20452743RESULT

  • van Saase JL, van Romunde LK, Cats A, Vandenbroucke JP, Valkenburg HA. Epidemiology of osteoarthritis: Zoetermeer survey. Comparison of radiological osteoarthritis in a Dutch population with that in 10 other populations. Ann Rheum Dis. 1989 Apr;48(4):271-80. doi: 10.1136/ard.48.4.271.

    PMID: 2712610RESULT

MeSH Terms

Conditions

PainPatient Satisfaction

Interventions

GlucoseMethylprednisolone Acetate

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tuna Ozyurekoglu, MD

    President

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julianne Sutton, MPH

CONTACT

5025620390jsutton@kleinertkutz.com

Rehan Zahid, MD

CONTACT

rzahid@kleinertkutz.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The clinical assessor is blinded to the baseline evaluations and to the administered treatments. Information about the medications used in the study will be given to the participants, but they will be blinded to their group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

April 1, 2021

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share