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Randomized Trial of Active vs Passive Splinting for Extensor Tendon Injuries in Zones IV to VI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06950268
Enrollment
30
Registered
2025-04-30
Start date
2020-07-01
Completion date
2021-08-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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). 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.

Interventions

DEVICEICAMS Splinting Protocol

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.

DEVICEClassic Plaster Immobilization

Participants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy.

Sponsors

Fundacin Biomedica Galicia Sur
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

This was a single-blind study. The outcomes assessor was blinded to group allocation. Participants and care providers were not blinded due to the visible nature of the splints.

Intervention model description

Randomized, single-blind, parallel-group design comparing ICAMS versus classic immobilization following extensor tendon tenorrhaphy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Grip Strength of the Injured Hand4 and 6 weeks after injuryGrip 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.

Secondary

MeasureTime frameDescription
Change in MCP Joint Flexion4 and 6 weeks after injuryActive flexion of the metacarpophalangeal (MCP) joints of the injured finger was measured to assess recovery of joint mobility.
Pain Intensity (VAS Score)4 and 6 weeks after injuryPain was evaluated using a 10-point Visual Analog Scale (VAS) at both follow-up visits.
Quick-DASH Score4 and 6 weeks after injuryUpper limb disability and function were assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.
Patient Comfort With Immobilization4 and 6 weeks after injuryPatients rated their comfort with the splint using a yes/no response at 4 weeks post-treatment.
Patient Satisfaction With Treatment Outcome4 and 6 weeks after injuryPatients reported overall satisfaction with the treatment using a yes/no response.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026