Effect of Paraffin Wax on Joint Contractures

September 24, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Other: Paraffin wax

Application of Paraffin wax on joint contracture for 20 mins before removal

Other: Mineral oil

Application of Mineral oil on joint contracture for 20 mins before removal
Experimental: 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
Other: Paraffin wax

Application of Paraffin wax on joint contracture for 20 mins before removal

Other: Mineral oil

Application of Mineral oil on joint contracture for 20 mins before removal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PROM changes
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AROM changes
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernadette Nedelec, PhD, OT(c), Centre hospitalier de l'Université de Montréal (CHUM)

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2027-13919

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

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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