Clinical trial NCT05425433: Serial Casting for Upper Extremity Burn Contractures
Official title: Should Serial Casting be a "First-resort" Conservative Treatment for Adults With Upper Extremity Burn Contractures?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Contracture of Skin
Keywords: Burns, Burn Rehabilitation, Serial Casting
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants will undergo a tailored intervention based on their needs.

Eligibility criteria: 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.

Primary outcomes:
measure: Passive range of motion changes
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
measure: Active range of motion changes
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Secondary outcomes:
measure: Patient reported upper-extremity function changes
timeFrame: Baseline, 3 weeks post intervention
measure: Scar patient satisfaction
timeFrame: Baseline, 3 weeks post intervention
measure: Skin Thickness Changes
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
measure: Skin Elasticity Changes
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
measure: Skin Erythema Changes
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
measure: Skin Melanin Changes
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
measure: Trans-epidermal water loss (TEWL)
timeFrame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital de réadaptation Villa Médica
state: Quebec
Study officials:
affiliation: CRCHUM
name: Bernadette Nedelec, PhD
role: PRINCIPAL_INVESTIGATOR
References: