Paraffin Wax and Exercise Prospective

A Pilot, Randomized Controlled Trial Evaluating the Effectiveness of Paraffin Wax On Burn Patient Function, Range of Motion and Scar

This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.

Study Overview

• Status: Recruiting
• Conditions: Scar; Burn; Exercise Therapy
• Intervention / Treatment: Device: standard of care exercise therapy; Device: paraffin wax

Detailed Description

If the participants agree to take part in this study, the participants scars will be looked at and the investigators will select one site that will be involved in the research. The scar will be "randomized" to the paraffin wax or no paraffin wax groups. The treatment the participants get will be chosen by chance, like flipping a coin. Neither the participants nor the study doctor will choose what treatment you get. The participants will have a 50% chance of being given either paraffin wax or not.

The study will take place in an outpatient setting. The participants will not be admitted to the hospital overnight. All patients who enter the study will be required to follow-up for regular appointments with their burn department.

Before the participants begin treatment, the participants will come in for a pre-treatment visit where the investigators will collection information about the participants scars such as pictures, range of motion measurements, non-invasive probes, non-invasive imaging (Laser doppler imaging) and questionnaires. These questionnaires will be related to the symptoms, range of motion, function, and appearance of the participants' burn scars. At the pre-treatment visit, there is an also an optional blood draw where less than 2 tablespoons of blood are collected. It is estimated this visit will take less than 1 hour. The investigators will also collect information from the medical record about prior surgical and medical history.

Exercise treatments (which the participants have previously chosen to undergo in talking with the participants doctor) will occur approximately in 1-2-week intervals depending on what the Burn Center scheduling department allows. For completion of this study, the participants will undergo 4 exercise therapy sessions which may take about 8 weeks.

At each visit, the following measurements will be captured before and after each exercise session. Those assigned to the paraffin wax group will have an additional assessment collected before their exercise therapy session and after the paraffin wax has been removed. Measurements at each visit include active and passive range of motion measurements of the affected joint, non-invasive probe measurements to measure water loss and hardness of your scar and the adjacent area of normal skin, digital photography, non-invasive laser doppler imaging (LDI), surface-level skin temperature measurements using either an infrared thermometer or skin temperature strip as well as pain and itch rating scales.

When applicable, the paraffin wax will be applied to the top of the scar for 15 minutes and repeat measurements previously listed above will be collected before your standard of care rehabilitation session. These sessions conducted by the burn rehab therapist may include scar massage, exercises, and functional activity. Specific treatments will be documented.

At each study visit, photographs will be taken of the study designated scar. All photographs taken for the purpose of this study will be taken by a high-resolution study camera. Photographs will be labeled with your study ID number. All efforts will be made to minimize the amount of identifiable information such as the participants' face or tattoos in these photos.

The procedures/treatments in this study that are considered experimental/investigation are: the use of the study product (paraffin wax) to assess the effect on burn scar that crosses an extremity joint during rehabilitation exercises.

The following procedures are part of the research study and would not normally be done as part of routine care: study provided paraffin wax and control application to the scar, scar assessments, digital photography, LDI, non-invasive imaging and measurements. These procedures are part of the study and will not be charged to insurance.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hosptial Center
      • Contact: Clinical Research Coordinator; Phone Number: 202-877-5170; Email: FBSRLRESEARCH@medstar.net
      • Principal Investigator: Bonnie C Carney, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients with burn scar that crosses an upper or lower extremity joint (shoulder, elbow, wrist, hand, hip, knee, ankle)
• Patients that have been prescribed a rehabilitation program where paraffin wax could be used as an adjunct to rehab exercise therapy

Exclusion Criteria:

• Adults unable to provide informed consent
• Injury etiology other than burn (ex: cutaneous trauma, cold injury, etc.)
• Pregnant women
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise Therapy Only	Device: standard of care exercise therapy; This is the group that will only receive exercise therapy and no paraffin wax.
Experimental: Exercise Therapy with Paraffin Wax Treatment	Device: standard of care exercise therapy; This is the group that will only receive exercise therapy and no paraffin wax.; Device: paraffin wax; This is the treatment group that will receive exercise and paraffin wax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion (degrees) of the affected joint before and after paraffin wax between the paraffin and no paraffin groups	4th exercise session, an average of 4 weeks post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trans-epidermal water loss	Trans-epidermal water loss (TEWL)(kg/m2h) of the HTS before and after paraffin wax between the paraffin and no paraffin groups. Minimum: 0 Maximum: 100 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Stiffness	Scar elasticity/hardness/stiffness by durometry (N/m) of the HTS before and after paraffin wax between the paraffin and no paraffin groups. Minimum: 0 Maximum: 300 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Pain visual analog scale	Pain visual analog scales (score) before and after paraffin wax between the paraffin and no paraffin groups. Minimum: 0 Maximum: 100 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Itch visual analog scale	Itch visual analog scales (score) before and after paraffin wax between the paraffin and no paraffin groups. Minimum: 0 Maximum: 100 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Scar surface temperature	Scar surface temperature (degrees celsius) before and after paraffin wax by scanner between the paraffin and no paraffin groups. Minimum: 0 Maximum: 100 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Patient and observer scar assessment scale	Pre and Post Study Patient and observer scar assessment scale (POSAS) version 3.0 pre and post paraffin at the first session and session four between the paraffin and no paraffin groups. Minimum: 0 Maximum: 10 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Perfusion	•Laser doppler imaging of perfusion (perfusion units) before and after paraffin wax first session only between the paraffin and no paraffin groups. Minimum: 0 Maximum: 500 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Lower extremities functional scale	• Pre (session 1) and Post (final session) study Lower extremity functional scale (LEFS) (score) between the paraffin and no paraffin groups. Minimum: 0 Maximum: 80 Lower score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment
Disabilities of the shoulder and hand	• Pre (session 1) and Post (final session) study disabilities of the arm, shoulder, and hand (DASH) (score) between the paraffin and no paraffin groups. Minimum: 30 Maximum: 150 Higher score is a worse outcome.	4th exercise session, an average of 4 weeks post enrollment

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: burn scar; scar; burn; range of motion; paraffin wax
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: STUDY00007987

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: Yes
• product manufactured in and exported from the U.S.: No