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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06194136
Study type Interventional
Source Tufts University
Contact Michelle Sawtelle, PhD
Phone 713-854-3811
Email msawtelle1@gmail.com
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date November 1, 2024

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