Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

Not Applicable

Not yet recruiting

• Conditions: Sensation Disorders; Neuropathic Pain
• Interventions: Device: PBM light therapy

• Registration Number: NCT06194136
• Lead Sponsor: Tufts University

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Study Start: 2024-06-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1

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

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Exclusion Criteria

• Active Malignancy
• Active Infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PBM Intervention	PBM light therapy	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale for Pain	Up to 10 weeks	Pain rating on a 0 to 10 scale
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)	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.
Semmes Weinstein Monofilament Testing	Up to 10 weeks	Light touch sensation assessment using monofilaments of different diameters

Secondary Outcome Measures

Name	Time	Method
The Quick Dash Outcome Measure	Up to 10 weeks	Self-rating outcome measure consisting of activity-based and mobility questions using the upper extremity.
Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1	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.
Range of motion assessment	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.
Strength testing (manual muscle testing and dynamometry)	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