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

NCT ID: NCT01783262

Last Updated: 2013-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis Trapezial-metacarpal Joint

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Extracorporeal shock wave therapy

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

Group Type ACTIVE_COMPARATOR

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Intervention Type DEVICE

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

sham extracorporeal shock wave therapy

The second grouop of patients received 0.04 mJ/mm2, 2400 pulses once a week for 4 weeks.

Group Type PLACEBO_COMPARATOR

Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Intervention Type DEVICE

Interventions

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Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

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

Intervention Type DEVICE

Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Ioppolo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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La Sapienza University

Rome, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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Interventional Study Design

Identifier Type: -

Identifier Source: org_study_id

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