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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04791202
• Other study ID #: 20.0174
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2021
• Source: Christine M. Kleinert Institute for Hand and Microsurgery
• Contact: Julianne Sutton, MPH
• Phone: 5025620390
• Email: jsutton[@]kleinertkutz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Functionality
• Pain
• Satisfaction, Patient

Intervention

Drug:
• Dextrose
See arm descriptions
• Methylprednisolone Acetate 40 MG/ML
See arm descriptions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Christine M. Kleinert Institute for Hand and Microsurgery	Kleinert, Kutz and Associates

References & 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. Review. — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-injection pain	visual analog score for pain (0 for no pain, 10 for worst pain)	1 day
Primary	post-injection functionality	Q-DASH score for functionality (0 for no disability, 100 for most disability)	1 day