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

May 23, 2025 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Angela Notarnicola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: "Minilith", Storz, Swiss
shock waves
Other Names:
  • ESWT
  • Extracorporeal Shock Waves Therapy
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
change between baseline to 6 months
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."
change between baseline to 1 month
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."
change between baseline to 3 months
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."
change between baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change between baseline to 1 month
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.
change between baseline to 3 months
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.
change between baseline to 6 months
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.
change between baseline to 12 months
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.
change between baseline to 1 month
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.
change between baseline to 3 months
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.
change between baseline to 6 months
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.
change between baseline to 12 months
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
change between 3 to 6 months
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
change between 3 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWEX-TO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thumb Osteoarthritis

Clinical Trials on "Minilith", Storz, Swiss

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe