Effects of Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy: a
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Tufts University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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:
- Initial sensation, range of motion, strength, pain, and quality of life assessments.
- Observation and demonstration of the PBM application with a study investigator present.
- 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.
- Documentation of pain and skin observation/sensation after each treatment session.
- 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.
- Weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention.
- Follow-up telephone calls by a study investigator during weeks 7-10.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
PBM Intervention
Application of commercially-available PBM over the skin of first the right breast and chest tissue and then the left breast and chest tissue, each for 30 seconds in single application. This intervention is to applied once per day, for a total of three times per week, with a minimum of 24 hours between each application.
Intervention: PBM light therapy (Device)
Outcomes
Primary Outcomes
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)
Time Frame: 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
Time Frame: Up to 10 weeks
Light touch sensation assessment using monofilaments of different diameters
Visual Analog Scale for Pain
Time Frame: Up to 10 weeks
Pain rating on a 0 to 10 scale
Secondary Outcomes
- The Quick Dash Outcome Measure(Up to 10 weeks)
- Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1(Up to 10 weeks)
- Range of motion assessment(Up to 10 weeks)
- Strength testing (manual muscle testing and dynamometry)(Up to 10 weeks)
Investigators
Kim Dao
Assistant Professor
Tufts University