ArthrosisAMADEONCT06633796
Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with Robotics in Patients with Erosive Osteoarthritis
A study testing AMADEO in people with Arthrosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Arthrosis
- What is being tested?
- AMADEO
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2021to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Arthrosis
- Being tested
- AMADEO, Standard of care
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMADEODevice
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 careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| AMADEO | Experimental | Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers. Receives: Device: AMADEO |
| Standard care | Other | Rehabilitation treatment with occupational therapy and paraffin therapy. Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS functionality
VAS scale
Measured: Baseline, 1, 3 and 6 months after treatment
Dreiser index
Dreiser index
Measured: Baseline, 1, 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start25 Jan 2021
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633796
- Sponsor's protocol ID
- 2020-60
- Acronym
- AMADEO
- Status last verified
- Nov 2024
- First submitted
- 7 Oct 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated
- ClinicalTrials.gov ID
- NCT06633796
- Acronym / sponsor ID
- AMADEO / 2020-60
- Conditions
- Arthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMADEO | Experimental | Device: AMADEORehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers. |
| Standard care | Other | Procedure: Standard of careRehabilitation treatment with occupational therapy and paraffin therapy. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMADEO304 / 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. | Device | AMADEO |
| Standard of careThe 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. | Procedure or surgery | Standard care |
Primary outcome
VAS functionality
Time frame: Baseline, 1, 3 and 6 months after treatment
VAS scale
Dreiser index
Time frame: Baseline, 1, 3 and 6 months after treatment
Dreiser index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMADEO in people with Arthrosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS functionality (time frame: Baseline, 1, 3 and 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.