Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with R… (NCT06633796) | Clinical Trial Compass
CompletedNot Applicable
Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with Robotics in Patients with Erosive Osteoarthritis
Italy40 participantsStarted 2021-01-25
Plain-language 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.
Who can participate
Age range
35 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VAS functionality
Timeframe: Baseline, 1, 3 and 6 months after treatment
2
Dreiser index
Timeframe: Baseline, 1, 3 and 6 months after treatment