Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

September 2, 2025 updated by: Kim Dao, Tufts University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78702
        • University of St Augustine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for Pain
Time Frame: Up to 10 weeks
Pain rating on a 0 to 10 scale
Up to 10 weeks
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.
Up to 10 weeks
Semmes Weinstein Monofilament Testing
Time Frame: Up to 10 weeks
Light touch sensation assessment using monofilaments of different diameters
Up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quick Dash Outcome Measure
Time Frame: Up to 10 weeks
Self-rating outcome measure consisting of activity-based and mobility questions using the upper extremity.
Up to 10 weeks
Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1
Time Frame: Up to 10 weeks
Self-rating outcome measure consisting of activity and emotional-based questions pertaining to participation and quality of life in the presence of neuropathic pain.
Up to 10 weeks
Range of motion assessment
Time Frame: Up to 10 weeks
Use of a standard goniometer to measure standard ranges of motion of the upper extremities into shoulder flexion, abduction, internal rotation, and external rotation.
Up to 10 weeks
Strength testing (manual muscle testing and dynamometry)
Time Frame: Up to 10 weeks
Manual muscle testing will consist of manual resistance applied according to a standardized protocol to assess strength of the upper extremities. Dynamometry will be used simultaneously for a numerical/objective representation of strength
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Investigators

  • Principal Investigator: Kim D Dao, DPT, Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tufts U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data, including that from subjective and objective assessment measures, will be stored without identifying information, in a shared password-protected drive shared only with the primary and co-investigators as named on this study.

IPD Sharing Time Frame

Data will be available to the research team up until 6 months after publication.

IPD Sharing Access Criteria

Any future studies that wish to mimic the study protocol for research purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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