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

The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Trapezial-metacarpal Joint
• Intervention / Treatment: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK; Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00185
    • La Sapienza University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extracorporeal shock wave therapy; an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.	Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK; an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
Placebo Comparator: sham extracorporeal shock wave therapy; The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks.	Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK; Other Names: an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	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	The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
Duruöz Hand Index (DHI)	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	The change in the mean of DHI at 3 and 6 months follow up
Disabilities of the Arm, Shoulder, and Hand questionnaire	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.	The changes in mean at 3 and 6 months follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): February 4, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Interventional Study Design