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

University of Roma La Sapienza

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Osteoarthritis Trapezial-metacarpal Joint

Interventions

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKDEVICE

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 SLKDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

La Sapienza University

Rome, Italy, Italy

Outcomes

Primary Outcomes

Visual Analogue Scale

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

Time frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention

Duruöz Hand Index (DHI)

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

Time frame: The change in the mean of DHI at 3 and 6 months follow up

Disabilities of the Arm, Shoulder, and Hand questionnaire

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.

Time frame: The changes in mean at 3 and 6 months follow up

Secondary Outcomes

grip and pinch tests

The measure of strength by hand grip and pinch tests, for continuous variables that were measured in kilograms with a standard dynamometer

Time frame: The change in mean at 3 and 6 months follow up

Data from ClinicalTrials.gov

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