Back to resultsThe Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.
Primary Purpose
Osteoarthritis Trapezial-metacarpal Joint
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Trapezial-metacarpal Joint
Eligibility Criteria
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.
Sites / Locations
- La Sapienza University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Extracorporeal shock wave therapy
sham extracorporeal shock wave therapy
Arm Description
an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks.
Outcomes
Primary Outcome Measures
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
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
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01783262
First Posted
January 29, 2013
Last Updated
January 31, 2013
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01783262
Brief Title
The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.
Official Title
The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Trapezial-metacarpal Joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Extracorporeal shock wave therapy
Arm Type
Active Comparator
Arm Description
an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
Arm Title
sham extracorporeal shock wave therapy
Arm Type
Placebo Comparator
Arm Description
The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Intervention Description
an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Other Intervention Name(s)
an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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
Time Frame
The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
Title
Duruöz Hand Index (DHI)
Description
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
Time Frame
The change in the mean of DHI at 3 and 6 months follow up
Title
Disabilities of the Arm, Shoulder, and Hand questionnaire
Description
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.
Time Frame
The changes in mean at 3 and 6 months follow up
Secondary Outcome Measure Information:
Title
grip and pinch tests
Description
The measure of strength by hand grip and pinch tests, for continuous variables that were measured in kilograms with a standard dynamometer
Time Frame
The change in mean at 3 and 6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
La Sapienza University
City
Rome
ZIP/Postal Code
00185
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.
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