Extracorporeal Shock Waves Therapy (ESWT) vs Exercise in Thumb Osteoarthritis
NCT ID: NCT06056765
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2024-01-01
2025-04-30
Brief Summary
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OA of the base of the first toe is mainly treated with conservative modalities, while surgical treatment will be reserved for those whose debilitating symptoms persist despite adequate conservative management. Surgical management, however, is associated with a number of complications, including tendon rupture, sensory changes, and wound infection.
Although a number of conservative therapies have proven effective for the management of hand OA, there are few high-quality clinical studies in the literature to date.
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Detailed Description
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Regarding pharmacological management, insufficient data are available to support the effectiveness of intra-articular therapy with corticosteroids or hyaluronic acid and their use is not recommended by the American College of Rheumatology guidelines (ACR) of 2012 . On the other hand, nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended to relieve pain associated with first toe base OA, and topical formulations are recommended over oral NSAIDs in more recent guidelines, due to a profile of superior security. However, their effect on function is minimal and transient (no more effective than placebo after 2 weeks).
The combination of non-pharmacological and pharmacological modalities in the management of hand OA is recommended by the European League Against Rheumatism (EULAR) guidelines and is frequently used in clinical practice. Despite this, direct evidence of the effectiveness of this strategy is lacking. There have been some studies evaluating combined treatment, although they have generally not been specific to OA of the base of the first toe. Furthermore, the combinations studied usually included exclusively nonpharmacological modalities, and to date no strategy has been found to be highly effective for improving pain and function for first toe base OA.
Determining an evidence-based treatment approach with a clinically significant effect on clinical outcomes would provide healthcare providers with a basis for decision making for the treatment of patients with thumb carpometacarpal osteoarthritis. This strategy does not yet exist, and decisions about the best combination of interventions are generally based on personal experience and the personal opinion of healthcare professionals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ESWT group
The therapy will be applied using a focused shock wave device ("Minilith", Storz, Swiss) at the pulley of the first extensor channel under ultrasound guidance. Shock wave therapy will be performed with the patient's hand in intermediate between pronation and supination and will be administered once a week, for 3 sessions. For each treatment session, 2000 pulses will be applied with an energy flux density of 0.09 mJ/mm2 (between 0.05 and 0.12 mJ/mm2) and a frequency of 4 pulses per second (4 Hz). Gel will be used between the probe and the skin during applications to ensure conductivity. No local anesthetic will be used. Patients in both groups will be instructed to use a brace during the day for 4 weeks following recruitment.
"Minilith", Storz, Swiss
shock waves
Exercise group
Patients will perform exercises for 4 weeks following recruitment. Patients in this group will be taught home exercises to improve the dynamic stability of the thumb metacarpal trapezius joint. The patient is instructed to perform a flexion of the trapeziometacarpal. If the individual is able to complete 10 repetitions with good technique, resistance will be added manually or with rubber bands. If this exercise is painful, they are asked to return to active movement only. Patients in both groups will be instructed to use a brace during the day for 4 weeks following recruitment.
No interventions assigned to this group
Interventions
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"Minilith", Storz, Swiss
shock waves
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinical picture that has been occurring for at least 6 months;
* pain scored with VAS scale at least 4/10.
Exclusion Criteria
* contra-indications to treatment with shock waves (neoplasia, pregnancy, thrombocytopenia, epilepsy, uncompensated heart disease or arrhythmia, pacemaker, local infections),
* corticosteroid infiltration or physical therapy in the previous 4 weeks.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
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Locations
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Angela Notarnicola
Bari, , Italy
Countries
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References
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Lane LB, Boretz RS, Stuchin SA. Treatment of de Quervain's disease:role of conservative management. J Hand Surg Br. 2001 Jun;26(3):258-60. doi: 10.1054/jhsb.2001.0568.
Stepan JG, London DA, Boyer MI, Calfee RP. Blood glucose levels in diabetic patients following corticosteroid injections into the hand and wrist. J Hand Surg Am. 2014 Apr;39(4):706-12. doi: 10.1016/j.jhsa.2014.01.014.
Cavaleri R, Schabrun SM, Te M, Chipchase LS. Hand therapy versus corticosteroid injections in the treatment of de Quervain's disease: A systematic review and meta-analysis. J Hand Ther. 2016 Jan-Mar;29(1):3-11. doi: 10.1016/j.jht.2015.10.004. Epub 2015 Nov 6.
Brinks A, Koes BW, Volkers AC, Verhaar JA, Bierma-Zeinstra SM. Adverse effects of extra-articular corticosteroid injections: a systematic review. BMC Musculoskelet Disord. 2010 Sep 13;11:206. doi: 10.1186/1471-2474-11-206.
Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-DeJong B. Randomised controlled trial of local corticosteroid injections for de Quervain's tenosynovitis in general practice. BMC Musculoskelet Disord. 2009 Oct 27;10:131. doi: 10.1186/1471-2474-10-131.
Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, Hagen KB. Systematic review of design and effects of splints and exercise programs in hand osteoarthritis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):834-48. doi: 10.1002/acr.20427.
Trellu S, Dadoun S, Berenbaum F, Fautrel B, Gossec L. Intra-articular injections in thumb osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Joint Bone Spine. 2015 Oct;82(5):315-9. doi: 10.1016/j.jbspin.2015.02.002. Epub 2015 Mar 14.
Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.
Henry KD, Rosemond C, Eckert LB. Effect of number of home exercises on compliance and performance in adults over 65 years of age. Phys Ther. 1999 Mar;79(3):270-7.
O'Brien VH, Giveans MR. Effects of a dynamic stability approach in conservative intervention of the carpometacarpal joint of the thumb: a retrospective study. J Hand Ther. 2013 Jan-Mar;26(1):44-51; quiz 52. doi: 10.1016/j.jht.2012.10.005. Epub 2012 Nov 21.
Mobargha N, Esplugas M, Garcia-Elias M, Lluch A, Megerle K, Hagert E. The effect of individual isometric muscle loading on the alignment of the base of the thumb metacarpal: a cadaveric study. J Hand Surg Eur Vol. 2016 May;41(4):374-9. doi: 10.1177/1753193415597114. Epub 2015 Aug 6.
Pellegrini VD Jr. Osteoarthritis at the base of the thumb. Orthop Clin North Am. 1992 Jan;23(1):83-102.
Moulton MJ, Parentis MA, Kelly MJ, Jacobs C, Naidu SH, Pellegrini VD Jr. Influence of metacarpophalangeal joint position on basal joint-loading in the thumb. J Bone Joint Surg Am. 2001 May;83(5):709-16. doi: 10.2106/00004623-200105000-00009.
Pisano K, Wolfe T, Lubahn J, Cooney T. Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: A randomized trial. J Hand Ther. 2023 Jul-Sep;36(3):546-559. doi: 10.1016/j.jht.2022.03.009. Epub 2022 Jul 8.
Other Identifiers
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SWEX-TO
Identifier Type: -
Identifier Source: org_study_id
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