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

Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04791202
Enrollment
130
Registered
2021-03-10
Start date
2021-04-01
Completion date
2022-07-01
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functionality, Pain, Satisfaction, Patient

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.

Interventions

DRUGDextrose

See arm descriptions

See arm descriptions

Sponsors

Kleinert, Kutz and Associates
CollaboratorOTHER
Christine M. Kleinert Institute for Hand and Microsurgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
post-injection pain1 dayvisual analog score for pain (0 for no pain, 10 for worst pain)
post-injection functionality1 dayQ-DASH score for functionality (0 for no disability, 100 for most disability)

Contacts

Primary ContactJulianne Sutton, MPH
jsutton@kleinertkutz.com5025620390
Backup ContactRehan Zahid, MD
rzahid@kleinertkutz.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026