Hand InjuriesNCT06950268
Randomized Trial of Active vs Passive Splinting for Extensor Tendon Injuries in Zones IV to VI
A study testing ICAMS Splinting Protocol and Classic Plaster Immobilization in people with Hand Injuries and Tendon Injuries, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial summary
This study compares two methods of post-operative immobilization after surgical repair (tenorrhaphy) of extensor tendons in the fingers. Patients were randomly assigned to receive either a standard plaster splint or an alternative splinting method that allows controlled finger movement (ICAMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries, Tendon Injuries
- What is being tested?
- ICAMS Splinting Protocol and Classic Plaster Immobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to 30 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Patients from the CHUVI Health Area
- Diagnosed with an acute, single, complete extensor tendon laceration in zones IV, V, or VI of the long fingers
- Treated with primary tenorrhaphy
- Provided signed informed consent
- Agreed to attend follow-up visits and comply with the study protocol
Who cannot join
- More than one extensor tendon laceration in the same hand
- Injuries involving the thumb
- Tendon injuries with loss of substance
- Associated injuries at the same level (e.g., bone fracture, nerve lesion)
- Patients with cognitive impairment or inability to follow the protocol
- Presence of other injuries or medical conditions that could interfere with assessment
Trial locations and contacts
1 site in 1 country.
Spain1 site
CHUVI Hospital (Complejo Hospitalario Universitario de Vigo)
Vigo, Pontevedra, 36312
About this study
Official title: A Randomized Controlled Trial Comparing Active and Passive Motion Splint Immobilization for the Treatment of Extensor Tendon Injuries in Zones IV to VI of the Hand
This study compares two methods of post-operative immobilization after surgical repair (tenorrhaphy) of extensor tendons in the fingers. Patients were randomly assigned to receive either a standard plaster splint or an alternative splinting method that allows controlled finger movement (ICAMS). The main goal was to determine which method leads to better recovery in terms of finger mobility, grip strength, pain, and patient comfort.
Read the detailed description
Extensor tendon injuries of the hand are commonly treated with immobilization for 4-6 weeks using a plaster splint in the intrinsic plus position. However, prolonged immobilization may lead to tendon adhesions, joint stiffness, and delayed return to function. This randomized controlled clinical trial evaluated the efficacy of an immediate controlled active motion splinting protocol (ICAMS) compared to classic immobilization (CI) following extensor tendon tenorrhaphy in zones IV, V, and VI. Thirty patients were randomly assigned to either group. Functional outcomes were assessed at 4 and 6 weeks post-injury, including grip strength, joint range of motion, pain (VAS), Quick-DASH score, and patient satisfaction. The ICAMS group showed significantly better results in all main functional parameters. These findings support the use of early active motion protocols in selected cases of extensor tendon injury to enhance recovery and patient comfort.
- Conditions
- Hand Injuries, Tendon Injuries
- Being tested
- ICAMS Splinting Protocol, Classic Plaster Immobilization
- Keywords
- Classic Immobilization, Hand Surgery, Postoperative Rehabilitation, Extensor Tendon Repair, ICAMS, Finger Tendon, Zones IV to VI, Controlled Motion Splint
- Medical subject headings
- Hand Injuries, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICAMS Splinting ProtocolDevice
Also called Immediate Controlled Active Motion Splinting, Dynamic Splint, Yoke Splint
The ICAMS protocol consisted of a daytime yoke splint maintaining the injured finger in 20° more extension than adjacent fingers, combined with a nocturnal static splint in the intrinsic plus position. The splinting was applied for 4 weeks following extensor tendon tenorrhaphy.
Classic Plaster ImmobilizationDevice
Also called Intrinsic Plus Position Splint, Standard Immobilization
Participants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy.
| Study group | Role | What they receive |
|---|---|---|
| ICAMS Group | Experimental | Participants received immediate controlled active motion splinting (ICAMS) after extensor tendon tenorrhaphy. The ICAMS protocol included a daytime yoke splint, which maintained the injured finger in 20° more extension than adjacent fingers, and a nocturnal intrinsic plus static splint. The protocol was maintained for 4 weeks post-surgery Receives: Device: ICAMS Splinting Protocol |
| Classic Immobilization Group | Active comparator | Participants received standard immobilization with a plaster splint in the intrinsic plus position following extensor tendon tenorrhaphy. The immobilization was maintained continuously for 4 weeks. Receives: Device: Classic Plaster Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Grip Strength of the Injured Hand
Grip strength was measured using a JAMAR manual dynamometer to evaluate functional recovery after extensor tendon tenorrhaphy. Measurements were taken at 4 and 6 weeks post-injury.
Measured: 4 and 6 weeks after injury
Secondary outcomes (5)
Change in MCP Joint Flexion
Active flexion of the metacarpophalangeal (MCP) joints of the injured finger was measured to assess recovery of joint mobility.
Measured: 4 and 6 weeks after injury
Pain Intensity (VAS Score)
Pain was evaluated using a 10-point Visual Analog Scale (VAS) at both follow-up visits.
Measured: 4 and 6 weeks after injury
Quick-DASH Score
Upper limb disability and function were assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.
Measured: 4 and 6 weeks after injury
Patient Comfort With Immobilization
Patients rated their comfort with the splint using a yes/no response at 4 weeks post-treatment.
Measured: 4 and 6 weeks after injury
Patient Satisfaction With Treatment Outcome
Patients reported overall satisfaction with the treatment using a yes/no response.
Measured: 4 and 6 weeks after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jul 2020
- Primary completion25 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies 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, single-blind, parallel-group design comparing ICAMS versus classic immobilization following extensor tendon tenorrhaphy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Cela-López, MD, Principal investigator, Sergas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950268
- Sponsor's protocol ID
- 2020/307
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cela-Lopez M, Mendez-Perez C, Dominguez-Prado DM, Garcia-Reza A, Alvarez-Alvarez L, Perez-Alfonso E, Castro-Menendez M. Relative Motion Extension Orthosis Versus Classic Immobilization in Extensor Tendon Repairs (Zones IV-VI of the Hand): A Randomized Controlled Trial. Hand (N Y). 2026 Feb 27:15589447261422483. doi: 10.1177/15589447261422483. Online ahead of print.
PubMed 41761624
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Active and Passive Motion Splint Immobilization for the Treatment of Extensor Tendon Injuries in Zones IV to VI of the Hand
- ClinicalTrials.gov ID
- NCT06950268
- Acronym / sponsor ID
- 2020/307
- Conditions
- Hand Injuries, Tendon Injuries
- Keywords
- Classic Immobilization, Hand Surgery, Postoperative Rehabilitation, Extensor Tendon Repair, ICAMS, Finger Tendon, Zones IV to VI, Controlled Motion Splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 30 Apr 2025 (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 study compares two methods of post-operative immobilization after surgical repair (tenorrhaphy) of extensor tendons in the fingers. Patients were randomly assigned to receive either a standard plaster splint or an alternative splinting method that allows controlled finger movement (ICAMS). The main goal was to determine which method leads to better recovery in terms of finger mobility, grip strength, pain, and patient comfort.
Detailed description
Extensor tendon injuries of the hand are commonly treated with immobilization for 4-6 weeks using a plaster splint in the intrinsic plus position. However, prolonged immobilization may lead to tendon adhesions, joint stiffness, and delayed return to function. This randomized controlled clinical trial evaluated the efficacy of an immediate controlled active motion splinting protocol (ICAMS) compared to classic immobilization (CI) following extensor tendon tenorrhaphy in zones IV, V, and VI. Thirty patients were randomly assigned to either group. Functional outcomes were assessed at 4 and 6 weeks post-injury, including grip strength, joint range of motion, pain (VAS), Quick-DASH score, and patient satisfaction. The ICAMS group showed significantly better results in all main functional parameters. These findings support the use of early active motion protocols in selected cases of extensor tendon injury to enhance recovery and patient comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind, parallel-group design comparing ICAMS versus classic immobilization following extensor tendon tenorrhaphy
| Arm | Type | Receives |
|---|---|---|
| ICAMS Group | Experimental | Device: ICAMS Splinting ProtocolParticipants received immediate controlled active motion splinting (ICAMS) after extensor tendon tenorrhaphy. The ICAMS protocol included a daytime yoke splint, which maintained the injured finger in 20° more extension than adjacent fingers, and a nocturnal intrinsic plus static splint. The protocol was maintained for 4 weeks post-surgery |
| Classic Immobilization Group | Active comparator | Device: Classic Plaster ImmobilizationParticipants received standard immobilization with a plaster splint in the intrinsic plus position following extensor tendon tenorrhaphy. The immobilization was maintained continuously for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Patients from the CHUVI Health Area
- Diagnosed with an acute, single, complete extensor tendon laceration in zones IV, V, or VI of the long fingers
- Treated with primary tenorrhaphy
- Provided signed informed consent
Key exclusion criteria (6 listed)
- More than one extensor tendon laceration in the same hand
- Injuries involving the thumb
- Tendon injuries with loss of substance
- Associated injuries at the same level (e.g., bone fracture, nerve lesion)
- Patients with cognitive impairment or inability to follow the protocol
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 |
|---|---|---|
| ICAMS Splinting ProtocolAlso: Immediate Controlled Active Motion Splinting, Dynamic Splint, Yoke SplintThe ICAMS protocol consisted of a daytime yoke splint maintaining the injured finger in 20° more extension than adjacent fingers, combined with a nocturnal static splint in the intrinsic plus position. The splinting was applied for 4 weeks following extensor tendon tenorrhaphy. | Device | ICAMS Group |
| Classic Plaster ImmobilizationAlso: Intrinsic Plus Position Splint, Standard ImmobilizationParticipants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy. | Device | Classic Immobilization Group |
Primary outcome
Change in Grip Strength of the Injured Hand
Time frame: 4 and 6 weeks after injury
Grip strength was measured using a JAMAR manual dynamometer to evaluate functional recovery after extensor tendon tenorrhaphy. Measurements were taken at 4 and 6 weeks post-injury.
5 secondary outcomes
Change in MCP Joint Flexion
Time frame: 4 and 6 weeks after injury
Pain Intensity (VAS Score)
Time frame: 4 and 6 weeks after injury
Quick-DASH Score
Time frame: 4 and 6 weeks after injury
Patient Comfort With Immobilization
Time frame: 4 and 6 weeks after injury
Patient Satisfaction With Treatment Outcome
Time frame: 4 and 6 weeks after injury
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 Apr 2025.
- Derived from this study: PubMed 41761624Cela-Lopez M, Mendez-Perez C, Dominguez-Prado DM, Garcia-Reza A, Alvarez-Alvarez L, Perez-Alfonso E, Castro-Menendez M. Relative Motion Extension Orthosis Versus Classic Immobilization in Extensor Tendon Repairs (Zones IV-VI of the Hand): A Randomized Controlled Trial. Hand (N Y). 2026 Feb 27:15589447261422483. doi: 10.1177/15589447261422483. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Miguel Cela-López, MD principal investigator
Sergas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICAMS Splinting Protocol and Classic Plaster Immobilization in people with Hand Injuries and Tendon Injuries, run by Fundacin Biomedica Galicia Sur 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 6 inclusion and 6 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 Apr 2025. 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 Grip Strength of the Injured Hand (time frame: 4 and 6 weeks after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06950268, which also lists 1 linked publication.
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 Apr 2025.