Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06194136
• Other study ID #: Tufts U
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Tufts University
• Contact: Michelle Sawtelle, PhD
• Phone: 713-854-3811
• Email: msawtelle1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Sensation Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale for Pain	Pain rating on a 0 to 10 scale	Up to 10 weeks
Primary	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 (Aß nerve fibers) will be assessed using a cotton ball, pinprick sensation (Ad nerve fibers) using a wooden cocktail stick, thermal sensation (Ad and C nerve fibers) using warm and cold objects, and vibration (Aß nerve fibers) using a tuning fork.	Up to 10 weeks
Primary	Semmes Weinstein Monofilament Testing	Light touch sensation assessment using monofilaments of different diameters	Up to 10 weeks
Secondary	The Quick Dash Outcome Measure	Self-rating outcome measure consisting of activity-based and mobility questions using the upper extremity.	Up to 10 weeks
Secondary	Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1	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
Secondary	Range of motion assessment	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
Secondary	Strength testing (manual muscle testing and dynamometry)	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