Flexion Contracture of Proximal Interphalangeal JointNCT05465603
Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:
A study testing ETDNO (Elastic Tension digital neoprene orthosis) in people with Flexion Contracture of Proximal Interphalangeal Joint and Joint Deformities, Acquired, run by Vicenç Punsola Izard at 1 site in Spain.
Trial summary
Introduction: Flexion contracture is one of the most frequent complications in finger trauma. The use of orthoses to obtain the best total end range time (TERT) is the most popular method to treat this pathology . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Flexion Contracture of Proximal Interphalangeal Joint, Joint Deformities, Acquired
- What is being tested?
- ETDNO (Elastic Tension digital neoprene orthosis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 14 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PIP flexion contracture
Who cannot join
- more than 6 month of contracture and more than 45º of flexion contracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results
Introduction: Flexion contracture is one of the most frequent complications in finger trauma. The use of orthoses to obtain the best total end range time (TERT) is the most popular method to treat this pathology . Until now, no orthosis applied for longer than 3 weeks had been able to achieve TERT longer than 12 hours.
Purpose of the study: To assess whether the elastic tension digital neoprene orthosis (ETDNO), using a serial dynamic program, can achieve a better result in ROM and TERT than other orthoses described in the literature.
Methods: analysis of outcomes in a sample of 30 patients with PIP joint flexion contracture treated with the ETDNO and serial dynamic program.
Read the detailed description
In this study the researcher will compare the efect of daily TERT treatment on the proximal interphalangeal joint contracture using an ETDNO. The investigator will treat two different groups one with a dose of from 11 to 13 hours of the ETDNO while the other one is treated with a dose of from 20 to 22 hours of daily TERT with the same device. This treatment will last three weeks and will be evalauted the first day, the he first week and the third week. At the end of the study the researcher will quantify the improvement on both groups to know which dailyTERT dose is the best option.
- Being tested
- ETDNO (Elastic Tension digital neoprene orthosis)
- Medical subject headings
- Joint Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETDNO (Elastic Tension digital neoprene orthosis)Device
A bespoke orthosis created from neoprene.
| Study group | Role | What they receive |
|---|---|---|
| 20-22 hours of daily TERT intervention | Experimental | Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks. Receives: Device: ETDNO (Elastic Tension digital neoprene orthosis) |
| 11-13 hours daily TERT intervention | Active comparator | Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks. Receives: Device: ETDNO (Elastic Tension digital neoprene orthosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension improvement
The degree of extension of the PIP at the end of the treatment compared with the beginning
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexion Contracture of Proximal Interphalangeal JointStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicenç Punsola Izard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vicenç Punsola Izard, Hand Therapy Barcelona
- Investigators
- Vicenç Punsola-Izard, Principal investigator, Hand Therapy Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465603
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2023
- First submitted
- 17 Jul 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be available in the papers published
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results
- ClinicalTrials.gov ID
- NCT05465603
- Acronym / sponsor ID
- 001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vicenç Punsola IzardUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 20 Jul 2022 (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.
Introduction: Flexion contracture is one of the most frequent complications in finger trauma. The use of orthoses to obtain the best total end range time (TERT) is the most popular method to treat this pathology . Until now, no orthosis applied for longer than 3 weeks had been able to achieve TERT longer than 12 hours.
Purpose of the study: To assess whether the elastic tension digital neoprene orthosis (ETDNO), using a serial dynamic program, can achieve a better result in ROM and TERT than other orthoses described in the literature.
Methods: analysis of outcomes in a sample of 30 patients with PIP joint flexion contracture treated with the ETDNO and serial dynamic program.
Detailed description
In this study the researcher will compare the efect of daily TERT treatment on the proximal interphalangeal joint contracture using an ETDNO. The investigator will treat two different groups one with a dose of from 11 to 13 hours of the ETDNO while the other one is treated with a dose of from 20 to 22 hours of daily TERT with the same device. This treatment will last three weeks and will be evalauted the first day, the he first week and the third week. At the end of the study the researcher will quantify the improvement on both groups to know which dailyTERT dose is the best option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20-22 hours of daily TERT intervention | Experimental | Device: ETDNO (Elastic Tension digital neoprene orthosis)Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks. |
| 11-13 hours daily TERT intervention | Active comparator | Device: ETDNO (Elastic Tension digital neoprene orthosis)Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PIP flexion contracture
Key exclusion criteria (1 listed)
- more than 6 month of contracture and more than 45º of flexion contracture
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 |
|---|---|---|
| ETDNO (Elastic Tension digital neoprene orthosis)A bespoke orthosis created from neoprene. | Device | 11-13 hours daily TERT intervention, 20-22 hours of daily TERT intervention |
Primary outcome
Extension improvement
Time frame: 3 weeks
The degree of extension of the PIP at the end of the treatment compared with the beginning
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 5 Jan 2023.
- Individual participant dataSharing planned: No. will be available in the papers published
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.
Vicenç Punsola-Izard principal investigator
Hand Therapy Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETDNO (Elastic Tension digital neoprene orthosis) in people with Flexion Contracture of Proximal Interphalangeal Joint and Joint Deformities, Acquired, run by Vicenç Punsola Izard at 1 site in Spain.
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 1 inclusion and 1 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 5 Jan 2023. 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 Spain. 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?
Extension improvement (time frame: 3 weeks). 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 5 Jan 2023.