- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425433
Serial Casting for Upper Extremity Burn Contractures
March 18, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
Should Serial Casting be a "First-resort" Conservative Treatment for Adults With 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will undergo a tailored intervention based on their needs.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 1C9
- Hôpital de réadaptation Villa Médica
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Serial casted joint
Tailored serial casting intervention following 1 week of usual care
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
|
|
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)
|
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline, 3 weeks post intervention
|
|
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).
|
Baseline, 3 weeks post intervention
|
|
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
|
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
|
|
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
|
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
|
|
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.
|
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
|
|
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
|
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)
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
|
Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bernadette Nedelec, PhD, CRCHUM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2022
Primary Completion (Actual)
August 31, 2025
Study Completion (Actual)
September 20, 2025
Study Registration Dates
First Submitted
June 14, 2022
First Submitted That Met QC Criteria
June 16, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 20, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22.084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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