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OpenTrials
Completed

NCT Number: NCT06633796

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

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.

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Key information

Conditions

Arthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. VAS functionality

    Time frame: Baseline, 1, 3 and 6 months after treatment

    VAS scale

  2. Dreiser index

    Time frame: Baseline, 1, 3 and 6 months after treatment

    Dreiser index

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

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

Acronym: AMADEO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Dec 2, 2024

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.

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