Extracorporeal Shock Waves Therapy (ESWT) vs Exercise in Thumb Osteoarthritis

NCT06056765 | Completed

• 1 other identifier: SWEX-TO
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a chronic joint disease with a high prevalence and a negative impact on the quality of life and a high economic burden. The most common form of OA is that involving the hands, which affects females three times more often. OA of the base of the first finger is present in 21% of the population over 40 years of age and is more frequently related to pain and disability than OA of the interphalangeal joint. In addition to pain, it can cause deformity, stiffness, reduced mobility and strength, resulting in difficulty performing common activities such as opening vessels, carrying weights and writing. 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.

Conditions

Thumb Osteoarthritis; Hand Injuries

Keywords

shock waves; exercise; conservative treatment; hand

Outcome Measures

Primary Outcomes (4)

• recovery of pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  change between baseline to 1 month

• recovery of pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  change between baseline to 3 months

• recovery of pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  change between baseline to 6 months

• recovery of pain

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  change between baseline to 12 months

Secondary Outcomes (10)

• functional recovery

  change between baseline to 1 month

• functional recovery

  change between baseline to 3 months

• functional recovery

  change between baseline to 6 months

• functional recovery

  change between baseline to 12 months

• disability recovery

  change between baseline to 1 month

Study Arms (2)

ESWT group

EXPERIMENTAL

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.

Device: "Minilith", Storz, Swiss

Exercise group

NO INTERVENTION

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.

Interventions

"Minilith", Storz, Swiss DEVICE

shock waves

Also known as: Extracorporeal Shock Waves Therapy, ESWT

ESWT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• arthrosis of the trapezoid-metacarpal with stage 1 or 2 of the Eaton-Littler radiographic classification and pain (recent radiograph within 6 months previously);
• clinical picture that has been occurring for at least 6 months;
• pain scored with VAS scale at least 4/10.

You may not qualify if:

• rheumatoid arthritis or outcomes of trauma in the affected area,
• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Angela Notarnicola

Bari, 70124, Italy

Location

Related Publications (15)

• 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.

  PMID: 11386780 BACKGROUND

• 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.

  PMID: 24679910 BACKGROUND

• 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.

  PMID: 26705671 BACKGROUND

• 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.

  PMID: 20836867 BACKGROUND

• 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.

  PMID: 19860883 BACKGROUND

• 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.

  PMID: 21630479 BACKGROUND

• 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.

  PMID: 25776442 BACKGROUND

• 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.

  PMID: 22563589 BACKGROUND

• 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.

  PMID: 17046965 BACKGROUND

• 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.

  PMID: 10078770 BACKGROUND

• 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.

  PMID: 23177671 BACKGROUND

• 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.

  PMID: 26253421 BACKGROUND

• Pellegrini VD Jr. Osteoarthritis at the base of the thumb. Orthop Clin North Am. 1992 Jan;23(1):83-102.

  PMID: 1729673 BACKGROUND

• 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.

  PMID: 11379740 BACKGROUND

• 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.

  PMID: 35811182 BACKGROUND

MeSH Terms

Conditions

Hand Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized prospective

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)