Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

Tufts University

Status: Not yet enrolling

Conditions: Neuropathic Pain; Sensation Disorders

Treatments: Device: PBM light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06194136

Tufts U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 estimated patient

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

PBM Intervention

Experimental group

Description:

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.

Treatment:

Device: PBM light therapy