Neuropathic PainNCT06194136
Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy
A study testing PBM light therapy in people with Neuropathic Pain and Sensation Disorders, run by Tufts University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neuropathic Pain, Sensation Disorders
- What is being tested?
- PBM light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active Malignancy
- Active Infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Initial sensation, range of motion, strength, pain, and quality of life assessments.
- Observation and demonstration of the PBM application with a study investigator present.
- 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.
- Documentation of pain and skin observation/sensation after each treatment session.
- 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.
- Weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention.
- 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.
- Conditions
- Neuropathic Pain, Sensation Disorders
- Being tested
- PBM light therapy
- Medical subject headings
- Neuralgia, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM light therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PBM light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Pain
Pain rating on a 0 to 10 scale
Measured: 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.
Measured: Up to 10 weeks
Semmes Weinstein Monofilament Testing
Light touch sensation assessment using monofilaments of different diameters
Measured: Up to 10 weeks
Secondary outcomes (4)
The Quick Dash Outcome Measure
Self-rating outcome measure consisting of activity-based and mobility questions using the upper extremity.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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.
Measured: Up to 10 weeks
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
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Why it stopped: Research team unable to complete study protocol with identified case participant due to participant and research team schedule/factors. Study will not proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Dao, Tufts University
- Investigators
- Kim D Dao, DPT, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194136
- Sponsor's protocol ID
- Tufts U
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 17295084Mustonen 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.
PubMed 32458104Ilhan 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.
PubMed 28797014Ezzati 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.
PubMed 31360374Mogahed 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.
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.
PubMed 36310679Cialdai 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.
PubMed 26355716Cruccu 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.
PubMed 29178033
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation on Neuropathic Pain and Sensation Post-mastectomy: a
- ClinicalTrials.gov ID
- NCT06194136
- Acronym / sponsor ID
- Tufts U
- Conditions
- Neuropathic Pain, Sensation Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research team unable to complete study protocol with identified case participant due to participant and research team schedule/factors. Study will not proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Initial sensation, range of motion, strength, pain, and quality of life assessments.
- Observation and demonstration of the PBM application with a study investigator present.
- 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.
- Documentation of pain and skin observation/sensation after each treatment session.
- 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.
- Weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBM Intervention | Experimental | Device: PBM light therapyApplication 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Active Malignancy
- Active Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBM light therapyThe 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. | Device | PBM Intervention |
Primary outcome
Visual Analog Scale for Pain
Time frame: 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)
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.
Semmes Weinstein Monofilament Testing
Time frame: Up to 10 weeks
Light touch sensation assessment using monofilaments of different diameters
4 secondary outcomes
The Quick Dash Outcome Measure
Time frame: Up to 10 weeks
Patient-Reported Outcome Measures Information System (PROMIS) 29 + 2 Profile Measure Profile v2.1
Time frame: Up to 10 weeks
Range of motion assessment
Time frame: Up to 10 weeks
Strength testing (manual muscle testing and dynamometry)
Time frame: Up to 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 17295084Baron 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.
- Background: PubMed 32458104Mustonen 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.
- Background: PubMed 28797014Ilhan 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.
- Background: PubMed 31360374Ezzati 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.
- BackgroundMogahed 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: PubMed 36310679Santiago 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.
- Background: PubMed 26355716Cialdai 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.
- Background: PubMed 29178033Cruccu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim D Dao, DPT principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM light therapy in people with Neuropathic Pain and Sensation Disorders, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194136, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.