NCT06194136

Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

Effects of Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy: a

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain
• Sensation Disorders

Interventions

Type	Name	Description
DEVICE	PBM 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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-10-01
• Completion: 2024-11-01
• First posted: 2024-01-08
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study