The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.
This study has been completed.
Sponsor:
University of Roma La Sapienza
Information provided by (Responsible Party):
Francesco Ioppolo, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01783262
First received: January 29, 2013
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Trapezial-metacarpal Joint |
Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. |
Resource links provided by NLM:
Further study details as provided by University of Roma La Sapienza:
Primary Outcome Measures:
- Visual Analogue Scale [ Time Frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention ] [ Designated as safety issue: No ]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) [ Time Frame: The change in the mean of DHI at 3 and 6 months follow up ] [ Designated as safety issue: No ]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 [ Time Frame: 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:
- grip and pinch tests [ Time Frame: 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
| Study Start Date: | December 2009 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Francesco Ioppolo, MD, PhD, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01783262 History of Changes |
| Other Study ID Numbers: | Interventional Study Design |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Italy: La Sapienza University |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013