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Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis

Primary Purpose

Pain, Satisfaction, Patient, Functionality

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dextrose
Methylprednisolone Acetate 40 MG/ML
Sponsored by
Christine M. Kleinert Institute for Hand and Microsurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Dextrose Group

    Methylprednisolone Acetate Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    post-injection pain
    visual analog score for pain (0 for no pain, 10 for worst pain)
    post-injection functionality
    Q-DASH score for functionality (0 for no disability, 100 for most disability)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 8, 2021
    Last Updated
    March 12, 2021
    Sponsor
    Christine M. Kleinert Institute for Hand and Microsurgery
    Collaborators
    Kleinert, Kutz and Associates
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04791202
    Brief Title
    Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis
    Official Title
    Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Christine M. Kleinert Institute for Hand and Microsurgery
    Collaborators
    Kleinert, Kutz and Associates

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Carpometacarpal osteoarthritis (OA) is a degenerative condition of the hand that causes pain, stiffness and weakness. It is the second most common site of degenerative disease in the hand after arthritis of the distal interphalangeal joints. The prevalence of symptomatic hand OA in people over 70 years of age has been estimated as 13.4 % for men and 26.2 % for women. OA is more frequent in older age groups, leading to considerable disability with a burden on health services and on the economy. Risk factor for carpometacarpal osteoarthritis of the thumb includes being female, middle age, previous trauma, repetitive use and inflammatory joint disease. Lifetime prevalence of this condition approaches 10%. Injections are a useful conservative treatment modality prior to considering surgical treatment. Corticosteroid injection is helpful in the treatment of the disease, but some patients gain only short-term benefits. Evolving reports are showing promising results for the application of dextrose as an alternative method for the treatment of Carpometacarpal osteoarthritis, based on their induction for growth factors and inflammatory mediators. For instance, prolotherapy has been used as a treatment of musculoskeletal pain with various etiologies. It has been suggested that prolotherapy induces little inflammation and stimulates endogenous repair especially by prompting release of growth factors. Dextrose is an agent commonly used for prolotherapy. 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 OA 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Satisfaction, Patient, Functionality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dextrose Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Methylprednisolone Acetate Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Dextrose
    Intervention Description
    See arm descriptions
    Intervention Type
    Drug
    Intervention Name(s)
    Methylprednisolone Acetate 40 MG/ML
    Intervention Description
    See arm descriptions
    Primary Outcome Measure Information:
    Title
    post-injection pain
    Description
    visual analog score for pain (0 for no pain, 10 for worst pain)
    Time Frame
    1 day
    Title
    post-injection functionality
    Description
    Q-DASH score for functionality (0 for no disability, 100 for most disability)
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Those patients with diagnosis of carpometacarpal (CMC) osteoarthritis Those patients who fit the age limits Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julianne Sutton, MPH
    Phone
    5025620390
    Email
    jsutton@kleinertkutz.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rehan Zahid, MD
    Email
    rzahid@kleinertkutz.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tuna Ozyurekoglu, MD
    Organizational Affiliation
    President
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18182958
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    20452743
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    2712610
    Citation
    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.
    Results Reference
    result

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    Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis

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