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:
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
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01783262

Locations
Italy
La Sapienza University
Rome, Italy, 00185
Sponsors and Collaborators
University of Roma La Sapienza
  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 October 23, 2014