- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07837687
Effect of Paraffin Wax on Joint Contractures
Effects of Paraffin Wax Therapy on Passive Range of Motion Post-burn Injury: a Pilot Randomized Control Trial
Limited studies have objectively evaluated the benefit on skin pliability, and relieving itch and pain of paraffin wax, nor has paraffin wax treatment been compared to mineral oil, which is an ingredient in therapeutic paraffin wax. The objective of this study is to examine the immediate impact after paraffin treatment compared with mineral oil controls on joint passive range of motion.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The development of joint contractures after a burn injury represents one of the most important morbidities leading to reduced function and quality of life. Paraffin wax is commonly applied to contracted joints for its proposed benefits of increasing skin pliability, and/or relieving itch and pain. This pilot study will determine the feasibility of performing a fully powered study to objectively evaluate whether paraffin wax therapy significantly improves PROM in adult burn survivors with joint contractures of greater than 15% normal joint ROM (upper or lower extremity) compared to equivalent mineral oil treated joint contractures. This study will characterize the changes in PROM, AROM, itch, and pain in adult burn survivors immediately after the application of paraffin wax treatment relative to an intra-individual control scar treated with mineral oil. This will be a prospective, evaluator-blinded, intra-individual, randomized, controlled, pre-post pilot study.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jakub Sawicki, MSc
- Telefonnummer: 4229 514-288-8201
- E-post: jakub.sawicki.chum@ssss.gouv.qc.ca
Studer Kontakt Backup
- Navn: Tomas Gagnon, MSc, PT
- Telefonnummer: 514-974-9702
- E-post: tomas.gagnon.vmed@ssss.gouv.qc.ca
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adult burn survivors (16 years and older)
- Have joint contractures ≥15% normal PROM at two different joints directly related to their burn injury/scars
- Are proficient in English and/or French
- Provide informed consent
Exclusion Criteria:
- Patients who have a cognitive/psychiatric condition that could impair their understanding of the consent process or adherence to protocol procedures
- Patients with neurological impairments related to their burn injury, such as a drop foot or a drop wrist
- Patients with pre-burn joint pathology that limited their PROM
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Joint contractures 1 wax, 2 oil
Two selectionned joint contractures on a single participant. Interventions : one joint with paraffin wax, second joint with mineral oil |
Application of Paraffin wax on joint contracture for 20 mins before removal Application of Mineral oil on joint contracture for 20 mins before removal |
|
Eksperimentell: Joint contractures 1 oil, 2 wax
Two selectionned joint contractures on a single participant. Interventions : one joint with mineral oil, second joint with paraffin wax |
Application of Paraffin wax on joint contracture for 20 mins before removal Application of Mineral oil on joint contracture for 20 mins before removal |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PROM changes
Tidsramme: 20 minutes (enrollment to end of visit)
|
Passive range of motion of joint contractures treated with Paraffin wax or Mineral oil, before and after treatment, following regular and revised scar goniometry in extension and flexion |
20 minutes (enrollment to end of visit)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AROM changes
Tidsramme: 20 minutes (enrollment to end of visit)
|
active range of motion of joint contractures treated with paraffin wax or mineral oil, before and after treatment, following regular and revised scar goniometry in extension and flexion |
20 minutes (enrollment to end of visit)
|
|
Pain changes in joint contractures
Tidsramme: 20 minutes (enrollment to end of visit)
|
Subjective pain of joint contractures treated with paraffin wax or mineral oil (before and after) with Visual analog thermometer |
20 minutes (enrollment to end of visit)
|
|
Itch changes in joint contractures
Tidsramme: 20 minutes (enrollment to end of visit)
|
Subjective itch of joint contractures treated with paraffin wax or mineral oil (before and after) with Visual analog thermometer |
20 minutes (enrollment to end of visit)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Bernadette Nedelec, PhD, OT(c), Centre hospitalier de l'Université de Montréal (CHUM)
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2027-13919
Plan for individuelle deltakerdata (IPD)
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