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

Primary Purpose

Thumb Osteoarthritis, Hand Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
"Minilith", Storz, Swiss
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring shock waves, exercise, conservative treatment, hand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Angela Notarnicola

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESWT group

Exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."
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."
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."
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."

Secondary Outcome Measures

functional recovery
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.
functional recovery
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.
functional recovery
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.
functional recovery
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.
disability recovery
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.
disability recovery
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.
disability recovery
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.
disability recovery
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.
perception of clinical improvement
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
perception of clinical improvement
Maudsley and Roles scale scores range from 0-4 points for excellent to poor

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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1. Study Identification

Unique Protocol Identification Number
NCT06056765
Brief Title
Extracorporeal Shock Waves Therapy (ESWT) vs Exercise in Thumb Osteoarthritis
Acronym
SWEX-TO
Official Title
Effect of ESWT Versus Exercise Treatment for Thumb Carpometacarpal Osteoarthritis: a Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis, Hand Injuries
Keywords
shock waves, exercise, conservative treatment, hand

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized prospective
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESWT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
"Minilith", Storz, Swiss
Other Intervention Name(s)
Extracorporeal Shock Waves Therapy, ESWT
Intervention Description
shock waves
Primary Outcome Measure Information:
Title
recovery of pain
Description
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."
Time Frame
change between baseline to 1 month
Title
recovery of pain
Description
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."
Time Frame
change between baseline to 3 months
Title
recovery of pain
Description
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."
Time Frame
change between baseline to 6 months
Title
recovery of pain
Description
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."
Time Frame
change between baseline to 12 months
Secondary Outcome Measure Information:
Title
functional recovery
Description
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.
Time Frame
change between baseline to 1 month
Title
functional recovery
Description
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.
Time Frame
change between baseline to 3 months
Title
functional recovery
Description
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.
Time Frame
change between baseline to 6 months
Title
functional recovery
Description
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.
Time Frame
change between baseline to 12 months
Title
disability recovery
Description
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.
Time Frame
change between baseline to 1 month
Title
disability recovery
Description
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.
Time Frame
change between baseline to 3 months
Title
disability recovery
Description
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.
Time Frame
change between baseline to 6 months
Title
disability recovery
Description
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.
Time Frame
change between baseline to 12 months
Title
perception of clinical improvement
Description
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Time Frame
change between 3 to 6 months
Title
perception of clinical improvement
Description
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Time Frame
change between 3 to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Angela Notarnicola
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Extracorporeal Shock Waves Therapy (ESWT) vs Exercise in Thumb Osteoarthritis

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