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

Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated

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.

Study Overview

• Status: Completed
• Conditions: Arthrosis
• Intervention / Treatment: Device: AMADEO; Procedure: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy
      • IRCCS Sacro Cuore Don Calabria di Negrar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMADEO; Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers.	Device: AMADEO; 304 / 5.000 The rehabilitation treatment includes 10 sessions of combined treatment of paraffin therapy, functional occupational therapy and polyarticular mobilization of the fingers with a robotic arm (Amadeo). The sessions will be scheduled 2 times a week for 5 consecutive weeks.
Other: Standard care; Rehabilitation treatment with occupational therapy and paraffin therapy.	Procedure: Standard of care; The rehabilitation treatment includes 10 sessions of combined treatment of paraffin therapy and occupational therapy for functional purposes. The sessions will be scheduled 2 times a week for 5 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS functionality	VAS scale	Baseline, 1, 3 and 6 months after treatment
Dreiser index	Dreiser index	Baseline, 1, 3 and 6 months after treatment

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 2020-60

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No