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

NCT06633796 | Completed

• 1 other identifier: 2020-60
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthrosis

Outcome Measures

Primary Outcomes (2)

• VAS functionality

  VAS scale

  Baseline, 1, 3 and 6 months after treatment

• Dreiser index

  Dreiser index

  Baseline, 1, 3 and 6 months after treatment

Study Arms (2)

AMADEO

EXPERIMENTAL

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

Device: AMADEO

Standard care

OTHER

Rehabilitation treatment with occupational therapy and paraffin therapy.

Procedure: Standard of care

Interventions

AMADEO DEVICE

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.

AMADEO

Standard of care PROCEDURE

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.

Standard care

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: January 25, 2021
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

IT (1)