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Completed

NCT Number: NCT05425433

Serial Casting for Upper Extremity Burn Contractures

The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in adults and a lack of studies using strong methodological approaches. There are also no studies investigating the effect of casting on hypertrophic scars (HSc) and on self-reported UE function. This study is a longitudinal case series design with a criteria for change on the use of serial casting for the treatment of upper extremity burn contractures. The purpose of this study is to estimate the extent to which range of motion (AROM and PROM), scar characteristics and patient-reported upper-extremity function changes following an individually-tailored serial casting treatment program after switching from one week of usual care and to determine if these changes can be maintained 3 weeks after stopping serial casting, for adult burn survivors who developed an upper-extremity joint contracture greater than 15% normal range of motion within 1-year post-burn. This study will be a longitudinal case series design with a criteria for change. A minimum of 12 participants will be recruited from the "Centre d'expertise pour les victimes de brûlures graves de l'ouest du Québec" (CEVBGOQ) and will undergo one week of "usual care". If the PROM of the joint does not improve after one week of usual care, the participant will start the serial casting process, which will be prescribed by the treating OT. PROM/AROM and scar characteristics will be measured using a revised goniometry protocol that incorporates cutaneokinematics (CKM) principles and precise skin measures (DermaScan C, Cutometer®, Mexameter® and Tewameter®) at baseline, every Monday and Friday of the treatment weeks and 3 weeks after treatment cessation. Self-reported UE function and satisfaction related to scarring will be assessed at baseline and 3 weeks after treatment cessation using the QuickDASH and the patient satisfaction assessment scale (PSAS). Analysis on ROM and scar characteristic will be conducted using a graphical representation with a projected "usual care" regression line to count how many outcomes were over the line once the treatment was introduced. This study will contribute to building evidence for the use of serial casting following UE burn contractures in the adult population.

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Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de réadaptation Villa Médica

Montreal, Quebec, H2X 1C9, Canada

About this study

Participants will undergo a tailored intervention based on their needs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation.
  • Fire, flame or scald burn injury

-≥16 years old

  • have provided informed consent.

Exclusion criteria

  • Frostbite, chemical or electrical burn injury
  • A premorbid musculoskeletal or neurological disorder that limited their ROM
  • Have sustained a neurological injury secondary to the burn injury
  • A psychiatric or cognitive disorder that limits their ability to follow the research protocol
  • Have been diagnosed with heterotopic ossification
  • PROM is contraindicated for any reason
  • Do not understand English or French.

Treatment and study plan

Tailored serial casting intercention

Other

Every participant will undergo 1 week of usual care for the affected joint according to the OT's prescription (static progressive, dynamic or serial static) combined with stretching, moisturizers, pressure therapy, or thermal modalities. After the one week of splinting, if the PROM of the targeted joint does not improve, the participant will start serial casting (Monday to Friday). Patients will have a cast applied on Monday morning and worn for 24hrs/day or for 48hrs according to the OTs and treating physician's decision (rationale documented).The OT will decide how many weeks the participant will be wearing casts and the rationale to stop this treatment will be documented. When the treatment is stopped, patients will be encouraged to wear a maintenance splint for the following 2 weeks.

Primary outcomes

  1. Passive range of motion changes

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    PROM measures by goniometer (standard and revised goniometry protocol)

  2. Active range of motion changes

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    AROM measures by goniometer (standard and revised goniometry protocol)

Secondary outcomes

  1. Patient reported upper-extremity function changes

    Time frame: Baseline, 3 weeks post intervention

    Short version of The Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); A higher score indicates a greater level of disability and severity, whereas, lower scores indicates a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).

  2. Scar patient satisfaction

    Time frame: Baseline, 3 weeks post intervention

    Patient satisfaction assessment scale (PSAS), A higher score indicates a lower satisfaction towards the scar. The score ranges from 6 (Very satisfied) to60 (Not satisfied at all).

  3. Skin Thickness Changes

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    Ultrasound skin measures, mm

  4. Skin Elasticity Changes

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    Skin elasticity measures (r0- Cutometer), mm

  5. Skin Erythema Changes

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.

  6. Skin Melanin Changes

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    Melanin index measured by Mexameter

  7. Trans-epidermal water loss (TEWL)

    Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

    Trans-epidermal water loss (TEWL) measured by Tewameter

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Should Serial Casting be a "First-resort" Conservative Treatment for Adults With Upper Extremity Burn Contractures?

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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