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OpenTrials
Completed

NCT Number: NCT01783262

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

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

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Key information

Conditions

Osteoarthritis Trapezial-metacarpal Joint

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Sapienza University

Rome, Italy, 00185

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Device

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

Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.

Important dates

Study start
2009
Primary completion
2011
First posted
Feb 4, 2013
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.