Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

NCT06194136 | Withdrawn FDA Device

• 1 other identifier: Tufts U
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Sensation Disorders

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale for Pain

  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)

  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

  Light touch sensation assessment using monofilaments of different diameters

  Up to 10 weeks

Secondary Outcomes (4)

• The Quick Dash Outcome Measure

  Up to 10 weeks

• Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1

  Up to 10 weeks

• Range of motion assessment

  Up to 10 weeks

• Strength testing (manual muscle testing and dynamometry)

  Up to 10 weeks

Study Arms (1)

PBM Intervention

EXPERIMENTAL

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

Interventions

PBM light therapy 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.

PBM Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active Malignancy
• Active Infection

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

University of St Augustine

Austin, Texas, 78702, United States

Location

Related Publications (8)

• Baron RH, Fey JV, Borgen PI, Stempel MM, Hardick KR, Van Zee KJ. Eighteen sensations after breast cancer surgery: a 5-year comparison of sentinel lymph node biopsy and axillary lymph node dissection. Ann Surg Oncol. 2007 May;14(5):1653-61. doi: 10.1245/s10434-006-9334-z. Epub 2007 Feb 13.

  PMID: 17295084 BACKGROUND

• Mustonen L, Vollert J, Rice ASC, Kalso E, Harno H. Sensory profiles in women with neuropathic pain after breast cancer surgery. Breast Cancer Res Treat. 2020 Jul;182(2):305-315. doi: 10.1007/s10549-020-05681-8. Epub 2020 May 27.

  PMID: 32458104 BACKGROUND

• Ilhan E, Chee E, Hush J, Moloney N. The prevalence of neuropathic pain is high after treatment for breast cancer: a systematic review. Pain. 2017 Nov;158(11):2082-2091. doi: 10.1097/j.pain.0000000000001004.

  PMID: 28797014 BACKGROUND

• Ezzati K, Fekrazad R, Raoufi Z. The Effects of Photobiomodulation Therapy on Post-Surgical Pain. J Lasers Med Sci. 2019 Spring;10(2):79-85. doi: 10.15171/jlms.2019.13. Epub 2019 Feb 25.

  PMID: 31360374 BACKGROUND

• Mogahed H, Badawy M, Aziz N. Low-level laser diode on post modified Radical Mastectomy Lymphedema: a randomized controlled trial. J Adv Pharm Res.2020;10(4):105-109.

  BACKGROUND

• Santiago R, Gomes S, Ozsarfati J, Zitney M. Photobiomodulation for modulation of neuropathic pain and improvement of scar tissue. Scars Burn Heal. 2022 Oct 26;8:20595131221134052. doi: 10.1177/20595131221134052. eCollection 2022 Jan-Dec.

  PMID: 36310679 BACKGROUND

• Cialdai F, Landini I, Capaccioli S, Nobili S, Mini E, Lulli M, Monici M. In vitro study on the safety of near infrared laser therapy in its potential application as postmastectomy lymphedema treatment. J Photochem Photobiol B. 2015 Oct;151:285-96. doi: 10.1016/j.jphotobiol.2015.08.003. Epub 2015 Aug 11.

  PMID: 26355716 BACKGROUND

• Cruccu G, Truini A. A review of Neuropathic Pain: From Guidelines to Clinical Practice. Pain Ther. 2017 Dec;6(Suppl 1):35-42. doi: 10.1007/s40122-017-0087-0. Epub 2017 Nov 24.

  PMID: 29178033 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Sensation Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim D Dao, DPT

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: January 8, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 9, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available to the research team up until 6 months after publication.
• Access Criteria: Any future studies that wish to mimic the study protocol for research purposes.

Locations

US (1)