Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Neurotization on QoL and Sensory Restoration

NCT05206565

Breast Reconstruction Neurotization

WITHDRAWN NA

Photobiomodulation for Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer

NCT05663723

Peripheral Nervous System Diseases AND Breast Neoplasms

COMPLETED NA

Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer

NCT03135392

Mastectomy Breast Reconstruction

WITHDRAWN NA

Symptom Management After Breast Cancer Surgery

NCT00686127

Neuropathic Pain Postmastectomy Pain

COMPLETED PHASE4

PBMT for the Prevention of CIPN

NCT03391271

Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain Sensation Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PBM light therapy

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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