Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

This study has been terminated.

(Unable to recruit adequate numbers of patients)

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00685880

First received: May 26, 2008

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Results First Received: July 27, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Thumb Carpometacarpal Joint Osteoarthritis
Interventions:	Drug: Prolotherapy (10% dextrose solution) Drug: Betamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the pool of referrals to the Mayo Hand Clinic who are interested in receiving an injection for their pain, agree to comply with the standardized hand therapy program, meet the inclusion/exclusion criteria and are able to make the scheduled follow-up visits from Mayo 2008 to July 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Prolotherapy Group	Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Corticosteroid Group	Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.

Participant Flow: Overall Study

	Prolotherapy Group	Corticosteroid Group
STARTED	0	2
COMPLETED	0	2
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Prolotherapy Group	Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Corticosteroid Group	Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Total	Total of all reporting groups

Baseline Measures

	Prolotherapy Group	Corticosteroid Group	Total
Number of Participants [units: participants]	0	2	2
Age [units: participants]
<=18 years		0	0
Between 18 and 65 years		0	0
>=65 years		2	2
Gender [units: participants]
Female		2	2
Male		0	0
Region of Enrollment [units: participants]
United States		2	2

Outcome Measures

1. Primary:

Number of Participants With a Decreased Pain Score >20% [ Time Frame: baseline, 6 month follow-up ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to low enrollment; no subject data was analyzed.

Results Point of Contact:

Name/Title: Dr. Jeffrey S. Brault
Organization: Mayo Clinic
phone: 507-284-1643
e-mail: brault.jeffrey@mayo.edu

Publications:

Asakawa H, Miyagawa J, Higashiyama S, Goishi K, Hanafusa T, Kuwajima M, Taniguchi N, Matsuzawa Y. High glucose and hyperosmolarity increase heparin-binding epidermal growth factor-like growth factor (HB-EGF) production in cultured human aortic endothelial cells. Cell Biochem Funct. 1996 Sep;14(3):181-6.

Berggren M, Joost-Davidsson A, Lindstrand J, Nylander G, Povlsen B. Reduction in the need for operation after conservative treatment of osteoarthritis of the first carpometacarpal joint: a seven year prospective study. Scand J Plast Reconstr Surg Hand Surg. 2001 Dec;35(4):415-7.

Clarkson MR, Murphy M, Gupta S, Lambe T, Mackenzie HS, Godson C, Martin F, Brady HR. High glucose-altered gene expression in mesangial cells. Actin-regulatory protein gene expression is triggered by oxidative stress and cytoskeletal disassembly. J Biol Chem. 2002 Mar 22;277(12):9707-12. Epub 2002 Jan 9. Erratum in: J Biol Chem 2002 Jun 21;277(25):23100-2.

Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: A survey of practitioners. Arch Phys Med Rehabil. 2006 Jul;87(7):909-13.

Day CS, Gelberman R, Patel AA, Vogt MT, Ditsios K, Boyer MI. Basal joint osteoarthritis of the thumb: a prospective trial of steroid injection and splinting. J Hand Surg [Am]. 2004 Mar;29(2):247-51.

Di Paolo S, Gesualdo L, Ranieri E, Grandaliano G, Schena FP. High glucose concentration induces the overexpression of transforming growth factor-beta through the activation of a platelet-derived growth factor loop in human mesangial cells. Am J Pathol. 1996 Dec;149(6):2095-106.

Glickel SZ. Clinical assessment of the thumb trapeziometacarpal joint. Hand Clin. 2001 May;17(2):185-95. Review.

Han DC, Isono M, Hoffman BB, Ziyadeh FN. High glucose stimulates proliferation and collagen type I synthesis in renal cortical fibroblasts: mediation by autocrine activation of TGF-beta. J Am Soc Nephrol. 1999 Sep;10(9):1891-9.

Jones SC, Saunders HJ, Qi W, Pollock CA. Intermittent high glucose enhances cell growth and collagen synthesis in cultured human tubulointerstitial cells. Diabetologia. 1999 Sep;42(9):1113-9.

Joshi R. Intraarticular corticosteroid injection for first carpometacarpal osteoarthritis. J Rheumatol. 2005 Jul;32(7):1305-6.

Liu YK, Tipton CM, Matthes RD, Bedford TG, Maynard JA, Walmer HC. An in situ study of the influence of a sclerosing solution in rabbit medial collateral ligaments and its junction strength. Connect Tissue Res. 1983;11(2-3):95-102.

Meenagh GK, Patton J, Kynes C, Wright GD. A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. Ann Rheum Dis. 2004 Oct;63(10):1260-3.

Murphy M, Godson C, Cannon S, Kato S, Mackenzie HS, Martin F, Brady HR. Suppression subtractive hybridization identifies high glucose levels as a stimulus for expression of connective tissue growth factor and other genes in human mesangial cells. J Biol Chem. 1999 Feb 26;274(9):5830-4.

Otsuka Y, Mizuta H, Takagi K, Iyama K, Yoshitake Y, Nishikawa K, Suzuki F, Hiraki Y. Requirement of fibroblast growth factor signaling for regeneration of epiphyseal morphology in rabbit full-thickness defects of articular cartilage. Dev Growth Differ. 1997 Apr;39(2):143-56.

Pai S, Talwalkar S, Hayton M. Presentation and management of arthritis affecting the trapezio-metacarpal joint. Acta Orthop Belg. 2006 Jan;72(1):3-10. Review.

Pellegrini VD Jr. Pathomechanics of the thumb trapeziometacarpal joint. Hand Clin. 2001 May;17(2):175-84, vii-viii. Review.

Pugliese G, Pricci F, Locuratolo N, Romeo G, Romano G, Giannini S, Cresci B, Galli G, Rotella CM, Di Mario U. Increased activity of the insulin-like growth factor system in mesangial cells cultured in high glucose conditions. Relation to glucose-enhanced extracellular matrix production. Diabetologia. 1996 Jul;39(7):775-84.

Reeves, K. (2000). Prolotherapy: Basic Science, Clinical Studies, and Technique. Pain Procedures in Clinical Practice. T. A. Lennard. Philadelphia, PA, Hanley and Belfus, INC.: 172-90.

Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80.

Reeves KD, Hassanein K. Randomized, prospective, placebo-controlled double-blind study of dextrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of clinical efficacy. J Altern Complement Med. 2000 Aug;6(4):311-20.

Reeves KD, Hassanein KM. Long-term effects of dextrose prolotherapy for anterior cruciate ligament laxity. Altern Ther Health Med. 2003 May-Jun;9(3):58-62.

Roos MD, Han IO, Paterson AJ, Kudlow JE. Role of glucosamine synthesis in the stimulation of TGF-alpha gene transcription by glucose and EGF. Am J Physiol. 1996 Mar;270(3 Pt 1):C803-11.

Swigart CR, Eaton RG, Glickel SZ, Johnson C. Splinting in the treatment of arthritis of the first carpometacarpal joint. J Hand Surg [Am]. 1999 Jan;24(1):86-91.

van Beuningen HM, Glansbeek HL, van der Kraan PM, van den Berg WB. Differential effects of local application of BMP-2 or TGF-beta 1 on both articular cartilage composition and osteophyte formation. Osteoarthritis Cartilage. 1998 Sep;6(5):306-17.

Wakitani S, Imoto K, Kimura T, Ochi T, Matsumoto K, Nakamura T. Hepatocyte growth factor facilitates cartilage repair. Full thickness articular cartilage defect studied in rabbit knees. Acta Orthop Scand. 1997 Oct;68(5):474-80.

Woo SL, Hildebrand K, Watanabe N, Fenwick JA, Papageorgiou CD, Wang JH. Tissue engineering of ligament and tendon healing. Clin Orthop Relat Res. 1999 Oct;(367 Suppl):S312-23. Review.

Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7.

Responsible Party:	Michael Joseph Gruba M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00685880 History of Changes
Other Study ID Numbers:	07-006348
Study First Received:	May 26, 2008
Results First Received:	July 27, 2012
Last Updated:	July 27, 2012
Health Authority:	United States: Institutional Review Board

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