Proximal Interphalangeal Finger Joint ContracturesNCT05625451
High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness
A study testing Elastic Tension Digital Neoprene Orthosis in people with Proximal Interphalangeal Finger Joint Contractures, run by Vicenç Punsola Izard at 1 site in Spain.
Trial summary
Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Interphalangeal Finger Joint Contractures
- What is being tested?
- Elastic Tension Digital Neoprene Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 1 Jan 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
None listed.
Who cannot join
- Patients with acute tendon injuries or fractures
- Patients with inflammatory conditions,
- Patients with proximal interphalangeal joint replacements,
- Patients with Dupuytren conservative treatments
- Patients lacking active proximal interphalangeal joint extension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Two Intervals of Daily Total End Range Time for Treatment of Proximal Interphalangeal Joint Flexion Contracture Using an Elastic Tension Digital Neoprene Orthosis
Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.
Read the detailed description
Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?
Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture
Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.
Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and
- Being tested
- Elastic Tension Digital Neoprene Orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Tension Digital Neoprene OrthosisDevice
The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.
| Study group | Role | What they receive |
|---|---|---|
| 20-22 hours of daily total end range time intervention | Experimental | used the elastic tension digital neoprene orthosis from twenty to twenty-two hours Receives: Device: Elastic Tension Digital Neoprene Orthosis |
| 11-13 hours daily total end range time intervention | Active comparator | used the elastic tension digital neoprene orthosis from eleven to thirteen hours Receives: Device: Elastic Tension Digital Neoprene Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proximal interphalangeal joint extension
difference in passive finger extension between the first day and the seventh day
Measured: 7 days
Change in the proximal interphalangeal joint extension
difference in passive finger extension between the first day and the twenty first day
Measured: 21 days
- Modified Weeks Test
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
Measured: fifteen minutes
- Contraction Test
Finger reaction at release of the orthosis
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Nov 2020
- Primary completion1 Jun 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Interphalangeal Finger Joint ContracturesStudies 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
- Model description
- Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625451
- Sponsor's protocol ID
- 002
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Two Intervals of Daily Total End Range Time for Treatment of Proximal Interphalangeal Joint Flexion Contracture Using an Elastic Tension Digital Neoprene Orthosis
- ClinicalTrials.gov ID
- NCT05625451
- Acronym / sponsor ID
- 002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Vicenç Punsola IzardUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 23 Nov 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.
Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.
Detailed description
Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?
Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture
Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.
Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
| Arm | Type | Receives |
|---|---|---|
| 20-22 hours of daily total end range time intervention | Experimental | Device: Elastic Tension Digital Neoprene Orthosisused the elastic tension digital neoprene orthosis from twenty to twenty-two hours |
| 11-13 hours daily total end range time intervention | Active comparator | Device: Elastic Tension Digital Neoprene Orthosisused the elastic tension digital neoprene orthosis from eleven to thirteen hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients with acute tendon injuries or fractures
- Patients with inflammatory conditions,
- Patients with proximal interphalangeal joint replacements,
- Patients with Dupuytren conservative treatments
- Patients lacking active proximal interphalangeal joint extension
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 |
|---|---|---|
| Elastic Tension Digital Neoprene OrthosisThe treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups. | Device | 11-13 hours daily total end range time intervention, 20-22 hours of daily total end range time intervention |
Primary outcome
Change in the proximal interphalangeal joint extension
Time frame: 7 days
difference in passive finger extension between the first day and the seventh day
Change in the proximal interphalangeal joint extension
Time frame: 21 days
difference in passive finger extension between the first day and the twenty first day
- Modified Weeks Test
Time frame: fifteen minutes
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
- Contraction Test
Time frame: 21 days
Finger reaction at release of the orthosis
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 30 Nov 2022.
- Individual participant dataSharing planned: No
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 Elastic Tension Digital Neoprene Orthosis in people with Proximal Interphalangeal Finger Joint Contractures, 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 0 inclusion and 5 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 30 Nov 2022. 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?
Change in the proximal interphalangeal joint extension (time frame: 7 days). The study lists 4 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 30 Nov 2022.