drugset / Trial / NCT00685880
Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
RandomizedParallel-groupTriple-blindTreatment
Summary
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
Timeline
- Start
- 2008-05
- Primary completion
- 2010-07
- Completion
- 2010-07
Publications
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- Background 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. doi: 10.1080/028443101317149381.
- Background 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. doi: 10.1074/jbc.M109172200. Epub 2002 Jan 9.
- Background 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. doi: 10.1016/j.apmr.2006.03.017.
- Background 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. doi: 10.1016/j.jhsa.2003.12.002.
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- Background Glickel SZ. Clinical assessment of the thumb trapeziometacarpal joint. Hand Clin. 2001 May;17(2):185-95.
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- Background 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. doi: 10.1681/ASN.V1091891.
- Background 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. doi: 10.1007/s001250051279.
- Background Joshi R. Intraarticular corticosteroid injection for first carpometacarpal osteoarthritis. J Rheumatol. 2005 Jul;32(7):1305-6.
- Background 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. doi: 10.3109/03008208309004846.
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- Background 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. doi: 10.1074/jbc.274.9.5830.
- Background 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. doi: 10.1046/j.1440-169x.1997.t01-1-00003.x.
- Background 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.
- Background Pellegrini VD Jr. Pathomechanics of the thumb trapeziometacarpal joint. Hand Clin. 2001 May;17(2):175-84, vii-viii.
- Background 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. doi: 10.1007/s001250050510.
- Background 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.
- Background 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.
- Background 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. doi: 10.1089/10755530050120673.
- Background 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.
- Background 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. doi: 10.1152/ajpcell.1996.270.3.C803.
- Background 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. doi: 10.1053/jhsu.1999.jhsu24a0086.
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- Background 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. doi: 10.1093/aje/kwf141.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Betamethasone | Other / unclassified | 0.25 ml | Other |
| Comparator | Betamethasone | Other / unclassified | 0.5 ml | Other |
| Subject | Dextrose | Unknown | 10 % | Other |