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

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ClinicalTrials.gov Identifier: NCT01783262
Recruitment Status : Completed
First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Francesco Ioppolo, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Trapezial-metacarpal Joint Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK Device: Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
Study Start Date : December 2009
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis Shock
U.S. FDA Resources

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 Name: an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.



Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 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

  2. Duruöz Hand Index (DHI) [ Time Frame: 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

  3. 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 :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783262


Locations
Italy
La Sapienza University
Rome, Italy, 00185
Sponsors and Collaborators
University of Roma La Sapienza

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
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases