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Completed

NCT Number: NCT06056765

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

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.

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Key information

Conditions

Thumb Osteoarthritis Behavior Hand Injuries Motor Activity Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angela Notarnicola

Bari, 70124, Italy

About this study

The review of the literature has shown that in thumb carpometacarpal osteoarthritis the use of braces leads to a reduction in pain, particularly in the long term, based on data from two studies. Additionally, hand exercises could improve grip strength and hand function.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

"Minilith", Storz, Swiss

Device

shock waves

Other names: Extracorporeal Shock Waves Therapy, ESWT

Primary outcomes

  1. recovery of pain

    Time frame: change between baseline to 1 month

    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."

  2. recovery of pain

    Time frame: change between baseline to 3 months

    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."

  3. recovery of pain

    Time frame: change between baseline to 6 months

    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."

  4. recovery of pain

    Time frame: change between baseline to 12 months

    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."

Secondary outcomes

  1. functional recovery

    Time frame: change between baseline to 1 month

    The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.

  2. functional recovery

    Time frame: change between baseline to 3 months

    The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.

  3. functional recovery

    Time frame: change between baseline to 6 months

    The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.

  4. functional recovery

    Time frame: change between baseline to 12 months

    The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.

  5. disability recovery

    Time frame: change between baseline to 1 month

    The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) contains 11 questions related to ability and pain in the past week. Scores range from 0 to 100; the higher the score, the greater the limitation/pain/disability.

  6. disability recovery

    Time frame: change between baseline to 3 months

    The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) contains 11 questions related to ability and pain in the past week. Scores range from 0 to 100; the higher the score, the greater the limitation/pain/disability.

  7. disability recovery

    Time frame: change between baseline to 6 months

    The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) contains 11 questions related to ability and pain in the past week. Scores range from 0 to 100; the higher the score, the greater the limitation/pain/disability.

  8. disability recovery

    Time frame: change between baseline to 12 months

    The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) contains 11 questions related to ability and pain in the past week. Scores range from 0 to 100; the higher the score, the greater the limitation/pain/disability.

  9. perception of clinical improvement

    Time frame: change between 3 to 6 months

    Maudsley and Roles scale scores range from 0-4 points for excellent to poor

  10. perception of clinical improvement

    Time frame: change between 3 to 12 months

    Maudsley and Roles scale scores range from 0-4 points for excellent to poor

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

Effect of ESWT Versus Exercise Treatment for Thumb Carpometacarpal Osteoarthritis: a Randomized Trial.

Acronym: SWEX-TO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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