Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with Robotics in Patients with Erosive Osteoarthritis (AMADEO)

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Completed

Conditions: Arthrosis

Treatments: Procedure: Standard of care; Device: AMADEO

Study type: Interventional

Funder types: Other

Identifiers

NCT06633796

2020-60

Details and patient eligibility

About

This is a randomized, evaluator-blinded, non-profit, single-center, exploratory, medical device clinical trial aimed at evaluating the efficacy in terms of reduction of functional limitation of the combination of occupational therapy, paraffin therapy, and robotic arm mobilization compared to the center's SoC, i.e. paraffin therapy and occupational therapy.

Enrollment: 40 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged between 35 and 70 years.
• Diagnosis of erosive osteoarthritis of the fingers confirmed clinically and radiologically.
• Presence of persistent functional limitation (at least 6 months) in finger flexion
• VAS value pain referred only to the hands > 5 in the week prior to enrollment in the study.
• Patients not responding to anti-inflammatory and steroid therapy used in the last 2 years.
• Patients eligible for occupational therapy and paraffin therapy.
• Signature of the Informed Consent Form for participation in the study and processing of personal data.

Exclusion criteria

• Patients aged < 35 years and > 70 years.
• Patients with diagnosis of overlapping arthritic pathologies.
• Patients undergoing hand surgery in the 6 months prior to the evaluation.
• Patients with functional alterations to the hands due to trauma.
• Patients with cognitive or mental disorders.
• Corticosteroid use within 6 months prior to baseline.
• Patients unable to use robots with mechanical arms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

AMADEO

Experimental group

Description:

Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers.

Treatment:

Device: AMADEO

Standard care

Other group

Description:

Rehabilitation treatment with occupational therapy and paraffin therapy.

Treatment:

Procedure: Standard of care