Neuropathic Pain, Sensation Disorders
Conditions
Brief summary
The goal of this case study is to examine the effects of Photobiomodulation (PBM) on neuropathic pain and sensation post-mastectomy in one female participant. Neuropathic pain and somatosensation will be primary measures, along with strength, range of motion testing, and measures of quality of life in response to exposure to PBM for 6 weeks.
Detailed description
The goal of this case study is to examine the effects of Photobiomodulation (PBM) on neuropathic pain and sensation post-mastectomy in one female participant. The main question\[s\] it aims to answer are: * Will there be a difference in subjective neuropathic pain reported after application of PBM using red and near-infrared wavelengths? * If a difference in symptoms is discovered, how many sessions were administered before such difference was noted? * Will there be an observed difference in sensation assessment after application of PBM using red and near-infrared wavelengths? * Will there be an observed difference on upper extremity mobility following application of PBM using red and near-infrared wavelengths? * Will there be a subjective difference in quality-of-life following application of PBM using red and near-infrared wavelengths? Participants will be asked to participate in: 1. Initial sensation, range of motion, strength, pain, and quality of life assessments. 2. Observation and demonstration of the PBM application with a study investigator present. 3. Application of the PBM device to both sides of the chest over the breast tissue for a total of 30 seconds 3 times a week for 6 weeks in the participant's home environment without a study investigator present. 4. Documentation of pain and skin observation/sensation after each treatment session. 5. Follow-up assessments of sensation, range of motion, strength, pain, and quality of life at the end of week 6 after all PBM treatments have been conducted. 6. Weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention. 7. Follow-up telephone calls by a study investigator during weeks 7-10. Researchers will compare pre and post assessment results of sensation, pain, range of motion, strength, and quality of life for any changes as a result of the PBM therapy.
Interventions
DEVICEPBM light therapy
The PBM machine consists of a dual light emitting diode (LED) cluster array with 105 light diodes within the 660 nanometer (nm) red light wavelength and the 850 nm near-infrared light wavelength. These wavelengths are both within the ranges noted in previous literature for neuropathic pain (1) and are within the World Association for Photobiomodulation (Laser) Therapy (WALT) guidelines for PBM therapy (2). Dosage will be determined according to the following equation: Laser output Power (Watts) x Time (seconds) divided by Beam Area (cm2)= J/cm2 (1). The PBM unit generates energy equal to 115 mW/cm2 with a surface area of 54.6 cm x 17 cm. Thus, for a target power output of 3.45 J, the participant will have a continuous irradiation duration of 30 seconds for each application (1). The participant will be asked to utilize the PBM device on breast tissue post-mastectomy for 30 seconds 3 times per week with at least 24 hours between each session. The duration of treatment will be 6 weeks.
Sponsors
Tufts University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female * Status-post mastectomy due to clinical diagnosis of breast cancer * Physician approval for participation in study * Independent with all mobility * Independent with cognitive decision-making
Exclusion criteria
* Active Malignancy * Active Infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain | Up to 10 weeks | Pain rating on a 0 to 10 scale |
| Cutaneous Testing using protocol by Cruccu and Truini. (Cruccu G, Truini A. A review of Neuropathic Pain: From Guidelines to Clinical Practice. Pain Ther. 2017;6(Suppl 1):35-42. doi:10.1007/s40122-017-0087-0) | Up to 10 weeks | Tactile sensation of light touch (Aβ nerve fibers) will be assessed using a cotton ball, pinprick sensation (Aδ nerve fibers) using a wooden cocktail stick, thermal sensation (Aδ and C nerve fibers) using warm and cold objects, and vibration (Aβ nerve fibers) using a tuning fork. |
| Semmes Weinstein Monofilament Testing | Up to 10 weeks | Light touch sensation assessment using monofilaments of different diameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Quick Dash Outcome Measure | Up to 10 weeks | Self-rating outcome measure consisting of activity-based and mobility questions using the upper extremity. |
| Strength testing (manual muscle testing and dynamometry) | Up to 10 weeks | Manual muscle testing will consist of manual resistance applied according to a standardized protocol to assess strength of the upper extremities. Dynamometry will be used simultaneously for a numerical/objective representation of strength |
| Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1 | Up to 10 weeks | Self-rating outcome measure consisting of activity and emotional-based questions pertaining to participation and quality of life in the presence of neuropathic pain. |
| Range of motion assessment | Up to 10 weeks | Use of a standard goniometer to measure standard ranges of motion of the upper extremities into shoulder flexion, abduction, internal rotation, and external rotation. |
Countries
United States
Outcome results
None listed