Paraffin Wax and Exercise Prospective

NCT06786884 | Recruiting FDA Device

• 1 other identifier: STUDY00007987
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burn; Scar; Exercise Therapy

Keywords

paraffin wax; burn scar; scar; burn; range of motion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Trans-epidermal water loss

  4th exercise session, an average of 4 weeks post enrollment

• Stiffness

  4th exercise session, an average of 4 weeks post enrollment

• Pain visual analog scale

  4th exercise session, an average of 4 weeks post enrollment

• Itch visual analog scale

  4th exercise session, an average of 4 weeks post enrollment

• Scar surface temperature

  4th exercise session, an average of 4 weeks post enrollment

Study Arms (2)

Exercise Therapy Only

OTHER

Device: standard of care exercise therapy

Exercise Therapy with Paraffin Wax Treatment

EXPERIMENTAL

Device: paraffin wax; Device: standard of care exercise therapy

Interventions

paraffin wax DEVICE

This is the treatment group that will receive exercise and paraffin wax

Exercise Therapy with Paraffin Wax Treatment

standard of care exercise therapy DEVICE

This is the group that will only receive exercise therapy and no paraffin wax.

Exercise Therapy Only; Exercise Therapy with Paraffin Wax Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hosptial Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 22, 2025
• Study Start: January 6, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)