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

About this trial
This is an interventional treatment trial for Pain
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
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
NCT ID
NCT04791202
First Posted
March 8, 2021
Last Updated
March 12, 2021
Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators
Kleinert, Kutz and Associates
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
Learn more about this trial
Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis
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