Acute PainNCT03674697
The Effect of Light Therapy on Post-Surgical Pain
A study testing Green LED light therapy and White LED light therapy in people with Acute Pain and Arthropathy of Knee, run by University of Arizona at 1 site in United States.
Trial summary
This is a prospective randomized clinical trial study to investigate two main aspects. The first aspect is to investigate the efficacy exposure to green light emitting diode (GLED) in reducing postoperative opioid medications requirements by 20% as the primary outcome amongst patients scheduled for elective total knee… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Arthropathy of Knee
- What is being tested?
- Green LED light therapy and White LED light therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years or older
- Scheduled for elective primary knee replacement surgery
- Able to understand, read, and write English
Who cannot join
- History of chronic pain requiring chronic opioids equal or greater than 90 Morphine Milligram Equivalent (MME)/day
- Severe psychological or psychiatric conditions
- Unanticipated surgical complications, such as prolonged bleeding requiring long hospital stay, infection, dehiscence, and airway complications (anesthesiologist unable to extubate secondary to pulmonary complications
- Surgery cannot be postponed eight weeks from the day of recruitment
- Colorblindness
- On disability, involved in a legal case pending, or receiving compensation for a work-related injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Tucson
Tucson, Arizona, 85724
About this study
This is a prospective randomized clinical trial study to investigate two main aspects. The first aspect is to investigate the efficacy exposure to green light emitting diode (GLED) in reducing postoperative opioid medications requirements by 20% as the primary outcome amongst patients scheduled for elective total knee replacement surgery (knee arthroplasty). The second aspect is to reduce postoperative pain by 30%, improve preoperative anxiety by 30%, and improve the quality of sleep pre and postoperatively by 30%.
Seventy participants scheduled for elective unilateral primary total knee arthroplasty (total knee replacement) will be recruited from the pain clinic or from the orthopedic surgery clinics at Banner-University Medical Center by the pain or orthopedic physicians who are key personnel of this study. Once a participant is identified, he/she will meet with one of the research team members to explain the nature of the clinical trial and undergo a standard of care medical history gathering and baseline physical examinations. If the participant meets all the inclusion and have no exclusion criteria, he/she will be presented with a written consent in English to explain all the risk and benefits of this clinical trial. Once a participant signs a consent, he or she will be randomized by the study statistician, in a 1:1 ratio to either a GLED group (treatment) or white light-emitting diode (WLED) group (control). The participant will be trained on how to use the light device by one of the research team members. All participants will be exposed to either GLED or WLED for 8 weeks prior to surgery and two additional weeks after surgery.
Read the detailed description
Participants who meet inclusion and exclusion criteria will be enrolled into the study after consenting. Patients will be interviewed and asked to provide their history of present conditions, past medical history, if they are on disability or receiving compensation for an injury, demographic information, and ethnic group (determined by self-identification). Additionally, patients will undergo a physical examination. The focus will be on the history of colorblindness and chronic pain. A pain assessment will be conducted, and this will be obtained verbally from the patient. Physical examinations will be obtained at the initial study visit and will be documented in the source documents.
The participants will be instructed to use the GLED or the WLED devices as follows:
Before surgery - The participants will be instructed to choose rooms in their home. These rooms must be dark and has no other source of light except the light device provided. The participants will be instructed to place the devices in their fields of vision and keep it between 3 feet away from their eyes. This distance is chosen based on the intensity of the light from our clinical trial, which corresponds to 100 lux. The participants will be asked not to stare directly at the light, but to rather allow it to enter their eyes from the periphery and to treat it as they would treat any other light fixture. The participants will be asked to have 2 hours of exposure every night. Given that participants may have different preferred time to go to bed, we will ask them to start the exposure any time after sunset when sunshine is no longer illuminating their chosen rooms for exposure. We will encourage the participants to participate in any activities that do not require additional lights so they do not fall asleep during the nightly light exposure. For example, the participants may enjoy reading (100 lux provide enough illumination for reading), listening to music, exercising, etc. The participants will be exposed nightly to their light for 8 weeks prior to surgery.
After Surgery - On average, half the participants may be discharged home from the hospital after they recover from anesthesia in the same day. The other half of the participants may be admitted to the hospital for 1-3 days on average based on their medical profile, the course of the surgery, and any complications or concerns of the surgeons or the anesthesiologists. For patients that will be discharged home on the same day, they will continue light exposure as they did before surgery. For patients who may be admitted to the hospital, we have already secured the approval from the hospital administrative staff as well as the nursing manager to allow the participants to utilize the light devices in the patients' rooms. The light devices were examined by the Facility Management (for electrical hazards) and Infection Control and both approved the use of the light devices in the hospital setting. The participants will place the light devices in their fields of vision in the patients' rooms. Patients and nurses are able to control the ambient lights in the rooms and it will be kept dark except for the light from the light devices for two hours every night. The participants will be exposed to the light for 2 hours in the evening prior to sleeping. If the surgery is scheduled late at night or if the participants has a slow emergence from anesthesia, they may not be awake during the first night in the hospital to have the light exposure. Once participants are discharged from the hospital, they will continue exposure to the light as they did before surgery for the remainder of the two weeks postoperatively.
Data Management:
Data will be collected on standardized case report forms and entered into a HIPPA-compliant electronic database (e.g. Microsoft Access) that provides an appropriate interface with a robust statistical package . All study-related hard copy materials will be stored in locked file cabinets.
- Conditions
- Acute Pain, Arthropathy of Knee
- Being tested
- Green LED light therapy, White LED light therapy
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green LED light therapyDevice
Also called Treatment
You will be asked to locate a dark room in your house 8 weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery (8 weeks). You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with your chosen time. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smartphones, tablets, etc.).
White LED light therapyDevice
Also called Control
You will be asked to locate a dark room in your house 8 weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery (8 weeks). You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with your chosen time. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smartphones, tablets, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group (Green LED) | Experimental | Subjects will be exposed to a Green LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge. Receives: Device: Green LED light therapy |
| Control Group (White LED) | Placebo comparator | Subjects will be exposed to a White LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge. Receives: Device: White LED light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of pain reducing medication used by the active treatment group and the control group.
Change in postoperative opioid medications requirements by 20% as assessed by opioid medication logs
Measured: 10 week period
Secondary outcomes (3)
The amount of pain reducing medication used by the active treatment group and the control group assessed by the Brief Pain Inventory survey.
Change in postoperative pain by 30% as assessed by the Brief Pain Inventory survey
Measured: 10 week period
The amount of pain reducing medication used by the active treatment group and the control group assessed by Amsterdam Preoperative Anxiety and Information Scale survey.
Change in preoperative anxiety by 30% as assessed by Amsterdam Preoperative Anxiety and Information Scale survey
Measured: 10 week period
The amount of pain reducing medication used by the active treatment group and the control group assessed by the Pittsburgh Sleep Quality Index survey.
Change in the quality of sleep pre and postoperatively by 30% as assessed by the Pittsburgh Sleep Quality Index survey
Measured: 10 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start5 Sep 2018
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohab Ibrahim, PhD MD, University of Arizona
- Investigators
- Mohab Ibrahim, PhD, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674697
- Sponsor's protocol ID
- 1808848766
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2018
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hassett AL, Aquino JK, Ilgen MA. The risk of suicide mortality in chronic pain patients. Curr Pain Headache Rep. 2014;18(8):436. doi: 10.1007/s11916-014-0436-1.
PubMed 24952608Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.
PubMed 18686750Hwang MH, Shin JH, Kim KS, Yoo CM, Jo GE, Kim JH, Choi H. Low level light therapy modulates inflammatory mediators secreted by human annulus fibrosus cells during intervertebral disc degeneration in vitro. Photochem Photobiol. 2015 Mar-Apr;91(2):403-10. doi: 10.1111/php.12415. Epub 2015 Jan 26.
PubMed 25557915Ibrahim MM, Patwardhan A, Gilbraith KB, Moutal A, Yang X, Chew LA, Largent-Milnes T, Malan TP, Vanderah TW, Porreca F, Khanna R. Long-lasting antinociceptive effects of green light in acute and chronic pain in rats. Pain. 2017 Feb;158(2):347-360. doi: 10.1097/j.pain.0000000000000767.
PubMed 28092651
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light Therapy on Post-Surgical Pain
- ClinicalTrials.gov ID
- NCT03674697
- Acronym / sponsor ID
- 1808848766
- Conditions
- Acute Pain, Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Sep 2018 (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.
This is a prospective randomized clinical trial study to investigate two main aspects. The first aspect is to investigate the efficacy exposure to green light emitting diode (GLED) in reducing postoperative opioid medications requirements by 20% as the primary outcome amongst patients scheduled for elective total knee replacement surgery (knee arthroplasty). The second aspect is to reduce postoperative pain by 30%, improve preoperative anxiety by 30%, and improve the quality of sleep pre and postoperatively by 30%.
Seventy participants scheduled for elective unilateral primary total knee arthroplasty (total knee replacement) will be recruited from the pain clinic or from the orthopedic surgery clinics at Banner-University Medical Center by the pain or orthopedic physicians who are key personnel of this study. Once a participant is identified, he/she will meet with one of the research team members to explain the nature of the clinical trial and undergo a standard of care medical history gathering and baseline physical examinations. If the participant meets all the inclusion and have no exclusion criteria, he/she will be presented with a written consent in English to explain all the risk and benefits of this clinical trial. Once a participant signs a consent, he or she will be randomized by the study statistician, in a 1:1 ratio to either a GLED group (treatment) or white light-emitting diode (WLED) group (control). The participant will be trained on how to use the light device by one of the research team members. All participants will be exposed to either GLED or WLED for 8 weeks prior to surgery and two additional weeks after surgery.
Detailed description
Participants who meet inclusion and exclusion criteria will be enrolled into the study after consenting. Patients will be interviewed and asked to provide their history of present conditions, past medical history, if they are on disability or receiving compensation for an injury, demographic information, and ethnic group (determined by self-identification). Additionally, patients will undergo a physical examination. The focus will be on the history of colorblindness and chronic pain. A pain assessment will be conducted, and this will be obtained verbally from the patient. Physical examinations will be obtained at the initial study visit and will be documented in the source documents.
The participants will be instructed to use the GLED or the WLED devices as follows:
Before surgery - The participants will be instructed to choose rooms in their home. These rooms must be dark and has no other source of light except the light device provided. The participants will be instructed to place the devices in their fields of vision and keep it between 3 feet away from their eyes. This distance is chosen based on the intensity of the light from our clinical trial, which corresponds to 100 lux. The participants will be asked not to stare directly at the light, but to rather allow it to enter their eyes from the periphery and to treat it as they would treat any other light fixture. The participants will be asked to have 2 hours of exposure every night. Given that participants may have different preferred time to go to bed, we will ask them to start the exposure any time after sunset when sunshine is no longer illuminating their chosen rooms for exposure. We will encourage the participants to participate in any activities that do not require additional lights so they do not fall asleep during the nightly light exposure. For example, the participants may enjoy reading (100 lux provide enough illumination for reading), listening to music, exercising, etc. The participants will be exposed nightly to their light for 8 weeks prior to surgery.
After Surgery - On average, half the participants may be discharged home from the hospital after they recover from anesthesia in the same day. The other half of the participants may be admitted to the hospital for 1-3 days on average based on their medical profile, the course of the surgery, and any complications or concerns of the surgeons or the anesthesiologists. For patients that will be discharged home on the same day, they will continue light exposure as they did before surgery. For patients who may be admitted to the hospital, we have already secured the approval from the hospital administrative staff as well as the nursing manager to allow the participants to utilize the light devices in the patients' rooms. The light devices were examined by the Facility Management (for electrical hazards) and Infection Control and both approved the use of the light devices in the hospital setting. The participants will place the light devices in their fields of vision in the patients' rooms. Patients and nurses are able to control the ambient lights in the rooms and it will be kept dark except for the light from the light devices for two hours every night. The participants will be exposed to the light for 2 hours in the evening prior to sleeping. If the surgery is scheduled late at night or if the participants has a slow emergence from anesthesia, they may not be awake during the first night in the hospital to have the light exposure. Once participants are discharged from the hospital, they will continue exposure to the light as they did before surgery for the remainder of the two weeks postoperatively.
Data Management:
Data will be collected on standardized case report forms and entered into a HIPPA-compliant electronic database (e.g. Microsoft Access) that provides an appropriate interface with a robust statistical package . All study-related hard copy materials will be stored in locked file cabinets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group (Green LED) | Experimental | Device: Green LED light therapySubjects will be exposed to a Green LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge. |
| Control Group (White LED) | Placebo comparator | Device: White LED light therapySubjects will be exposed to a White LED light for 8 weeks prior to surgery, during their hospital stay and for an additional 2 weeks after hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 years or older
- Scheduled for elective primary knee replacement surgery
- Able to understand, read, and write English
Key exclusion criteria (6 listed)
- History of chronic pain requiring chronic opioids equal or greater than 90 Morphine Milligram Equivalent (MME)/day
- Severe psychological or psychiatric conditions
- Unanticipated surgical complications, such as prolonged bleeding requiring long hospital stay, infection, dehiscence, and airway complications (anesthesiologist unable to extubate secondary to pulmonary complications
- Surgery cannot be postponed eight weeks from the day of recruitment
- Colorblindness
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 |
|---|---|---|
| Green LED light therapyAlso: TreatmentYou will be asked to locate a dark room in your house 8 weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery (8 weeks). You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with your chosen time. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smartphones, tablets, etc.). | Device | Active Treatment Group (Green LED) |
| White LED light therapyAlso: ControlYou will be asked to locate a dark room in your house 8 weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery (8 weeks). You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with your chosen time. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smartphones, tablets, etc.). | Device | Control Group (White LED) |
Primary outcome
The amount of pain reducing medication used by the active treatment group and the control group.
Time frame: 10 week period
Change in postoperative opioid medications requirements by 20% as assessed by opioid medication logs
3 secondary outcomes
The amount of pain reducing medication used by the active treatment group and the control group assessed by the Brief Pain Inventory survey.
Time frame: 10 week period
The amount of pain reducing medication used by the active treatment group and the control group assessed by Amsterdam Preoperative Anxiety and Information Scale survey.
Time frame: 10 week period
The amount of pain reducing medication used by the active treatment group and the control group assessed by the Pittsburgh Sleep Quality Index survey.
Time frame: 10 week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Results publication: PubMed 24952608Hassett AL, Aquino JK, Ilgen MA. The risk of suicide mortality in chronic pain patients. Curr Pain Headache Rep. 2014;18(8):436. doi: 10.1007/s11916-014-0436-1.
- Results publication: PubMed 18686750Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.
- Results publication: PubMed 25557915Hwang MH, Shin JH, Kim KS, Yoo CM, Jo GE, Kim JH, Choi H. Low level light therapy modulates inflammatory mediators secreted by human annulus fibrosus cells during intervertebral disc degeneration in vitro. Photochem Photobiol. 2015 Mar-Apr;91(2):403-10. doi: 10.1111/php.12415. Epub 2015 Jan 26.
- Results publication: PubMed 28092651Ibrahim MM, Patwardhan A, Gilbraith KB, Moutal A, Yang X, Chew LA, Largent-Milnes T, Malan TP, Vanderah TW, Porreca F, Khanna R. Long-lasting antinociceptive effects of green light in acute and chronic pain in rats. Pain. 2017 Feb;158(2):347-360. doi: 10.1097/j.pain.0000000000000767.
- Individual participant dataSharing planned: No
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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.
Mohab Ibrahim, PhD, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green LED light therapy and White LED light therapy in people with Acute Pain and Arthropathy of Knee, run by University of Arizona 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
The amount of pain reducing medication used by the active treatment group and the control group. (time frame: 10 week period). 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 NCT03674697, which also lists 4 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 31 Jul 2025.