Paraffin Wax and Exercise Prospective
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Adults unable to provide informed consent
Injury etiology other than burn (ex: cutaneous trauma, cold injury, etc.)
Pregnant women
Prisoners
Trial design
Design model
Parallel
Treatments tested in this trial
paraffin wax
DeviceThis is the treatment group that will receive exercise and paraffin wax
standard of care exercise therapy
DeviceThis is the group that will only receive exercise therapy and no paraffin wax.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Exercise Therapy OnlyOther 1 intervention
Group B: Exercise Therapy with Paraffin Wax TreatmentExperimental treatment 2 interventions
Trial outcomes
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
Time frame
4th exercise session, an average of 4 weeks post enrollmentSecondary outcomes
1
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.
Time frame
4th exercise session, an average of 4 weeks post enrollment2
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.
Time frame
4th exercise session, an average of 4 weeks post enrollment3
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.
Time frame
4th exercise session, an average of 4 weeks post enrollment4
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.
Time frame
4th exercise session, an average of 4 weeks post enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov