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

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.

Study Overview

• Status: Completed
• Conditions: Tendon Injuries; Hand Injuries
• Intervention / Treatment: Device: ICAMS Splinting Protocol; Device: Classic Plaster Immobilization

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • CHUVI Hospital (Complejo Hospitalario Universitario de Vigo)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICAMS Group; 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	Device: ICAMS 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.; Other Names: Immediate Controlled Active Motion Splinting; Dynamic Splint; Yoke Splint
Active Comparator: Classic Immobilization Group; 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.	Device: Classic Plaster Immobilization; Participants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy.; Other Names: Intrinsic Plus Position Splint; Standard Immobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 and 6 weeks after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MCP Joint Flexion	Active flexion of the metacarpophalangeal (MCP) joints of the injured finger was measured to assess recovery of joint mobility.	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.	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.	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.	4 and 6 weeks after injury
Patient Satisfaction With Treatment Outcome	Patients reported overall satisfaction with the treatment using a yes/no response.	4 and 6 weeks after injury

Collaborators and Investigators

• Sponsor: Fundacin Biomedica Galicia Sur
• Investigators: Principal Investigator: Miguel Cela-López, MD, Sergas

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Rehabilitation; Hand Surgery; Classic Immobilization; Extensor Tendon Repair; ICAMS; Finger Tendon; Zones IV to VI; Controlled Motion Splint
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries; Tendon Injuries
• Other Study ID Numbers: 2020/307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No