The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.

Not Applicable

Completed

• Conditions: Osteoarthritis Trapezial-metacarpal Joint
• Interventions: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

• Registration Number: NCT01783262
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-06
• Status Verified: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Study First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older. Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.

Exclusion Criteria

• Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extracorporeal shock wave therapy	Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK	an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention	It is a horizontal line, 10 cm in length with 0 cm labeled "no pain" and 10 cm labeled "worst pain I have ever had". The patient marks on the line the point that they feel represents their perception of their current state
Duruöz Hand Index (DHI)	The change in the mean of DHI at 3 and 6 months follow up	is a self-report questionnaire which measures hand functional ability detecting how much difficulty the patient has performing eighteen daily tasks of living in reference to hand function. Each item is scored from 0 (performed without difficulty) to 5 (impossible to do). A total score is obtained by adding the scores of all questions (range 0-90). A higher score indicates greater disability. It was found that this scale is reliable and valid in patients with osteoarthritis
Disabilities of the Arm, Shoulder, and Hand questionnaire	The changes in mean at 3 and 6 months follow up	It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). The score ranges from 0 to 100, where 0 disability and 100 most severe disability.

Secondary Outcome Measures

Name	Time	Method
grip and pinch tests	The change in mean at 3 and 6 months follow up	The measure of strength by hand grip and pinch tests, for continuous variables that were measured in kilograms with a standard dynamometer

Trial Locations

Locations (1)

La Sapienza University; 🇮🇹 Rome, Italy