Clinical trial NCT06194136: Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy
Official title: Effects of Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy: a
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuropathic Pain
Sensation Disorders
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: Up to 10 weeks
measure: 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)
timeFrame: Up to 10 weeks
measure: Semmes Weinstein Monofilament Testing
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: The Quick Dash Outcome Measure
timeFrame: Up to 10 weeks
measure: Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1
timeFrame: Up to 10 weeks
measure: Range of motion assessment
timeFrame: Up to 10 weeks
measure: Strength testing (manual muscle testing and dynamometry)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tufts University
name: Kim D Dao, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.
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.
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.
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.
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.