Pain ManagementNCT07750912
Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study
A study testing LightForce XLI in people with Pain Management and TKA, run by Mohammad Burney, MD.
Trial summary
A pilot study to assess the efficacy and feasibility of PBMT for pain control in patients undergoing a TKA and are discharged the same day from an ambulatory surgery center. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Pain Management, TKA, Post Operative Analgesia
- What is being tested?
- LightForce XLI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2028
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI less than or equal to 45
- Currently set up for an elective primary total knee arthroplasty due to primary osteoarthritis
- Ability to provide informed consent to participate in the clinical trial
- Ability to understand and communicate in English
- Willingness to comply with all study procedures
Who cannot join
- poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C > 8.0) renal insufficiency (eGFR <60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
- inability to receive the intervention including contraindications and/or known photosensitivity.
- patients with history of total joint infection ever or any infection in the last 6 months
- ASA score >3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score > 80.
- previous PBMT treatment within 3 months from the start of the study for the participant.
- utilization of supplemental/holistic methods specifically for pain control (e.g. cannabidiol). This will be discontinued 30 days prior to TKA and will not be used during the duration of study participation. This will be evaluated by the Principal Investigator and study team prior to consent.
Show all 17Show fewer
- significant anti-coagulation usage (other than aspirin) 7 days prior to treatment
- CV surgery within the last 6 months
- significant neurologic compromise (acquired or congenital/genetic) of the lower extremity to be operated on or underlying neurologic condition that would confound results in the opinion of the investigator such as a previous brachial plexus injury after a motor vehicle accident or myasthenia gravis
- regular opioid use prior to surgical intervention as defined as >20 MME per day for 30 days prior to enrollment.
- Intolerance/allergy to hydrocodone or codeine
- significant physical deformity of the planned operative extremity that would confound the results in the opinion of the investigator(s)
- Immunocompromised patients, that in the opinion of the investigators, would confound the patient's ability to heal such as rheumatoid arthritis patient taking immunosuppressants.
- females who are pregnant or who are expecting to be pregnant for the duration of the study
- any tattoos or other permanent markings located on the treatment area
- Male patients or female who are not pregnant and do not plan on future pregnancy during trial participation, between 30-65 years of age
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A pilot study to assess the efficacy and feasibility of PBMT for pain control in patients undergoing a TKA and are discharged the same day from an ambulatory surgery center.
Read the detailed description
Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgeries in the United States, with the volume of procedures steadily rising due to an aging population and the growing prevalence of osteoarthritis. Given the shift toward outpatient settings and same-day discharges, effective postoperative pain management has become increasingly crucial for successful recovery in TKA patients.
Traditional pain management strategies in TKA, including nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, often begin perioperatively as part of a multimodal approach. Although NSAIDs and opioids can effectively reduce pain, they carry significant risks. Opioids are associated with dependency, respiratory depression, and other adverse effects, while NSAIDs pose risks of gastrointestinal bleeding, renal impairment, and cardiovascular complications. This creates a pressing need for alternative, non-pharmacological methods of pain management, particularly for patients discharged on the same day who must manage pain effectively without excessive reliance on opioids.
PBMT has emerged as a promising adjunct in managing postoperative pain. PBMT involves applying light in the red to near-infrared spectrum, which penetrates tissue, stimulating cellular processes that can reduce inflammation and promote healing. Mechanistically, PBMT enhances mitochondrial activity, increasing adenosine triphosphate (ATP) production, modulating reactive oxygen species (ROS), and upregulating transcription factors related to anti-inflammatory effects. This non-invasive therapy has shown efficacy in reducing pain and inflammation in various musculoskeletal and postoperative contexts.
Although PBMT has been widely applied in managing chronic pain and inflammation, its use in immediate postoperative care for patients undergoing same-day discharge TKA has not been evaluated. Given its potential to reduce pain without the risks associated with pharmacologic therapies, PBMT may provide a valuable addition to pain management protocols in TKA.
The primary aim of this clinical trial is to evaluate the feasibility and effectiveness of PBMT in managing postoperative pain for patients undergoing TKA with same-day discharge. Pain will be assessed through PROMIS pain measures, opioid usage in morphine milligram equivalents (MME), and additional parameters related to recovery and function, including the Knee Osteoarthritis Outcome Score (KOOS) and range of motion (ROM). The trial will explore whether PBMT can decrease reliance on opioids, improve functional outcomes, and offer a safer, more sustainable pain management strategy for TKA patients in outpatient settings.
- Being tested
- LightForce XLI
- Keywords
- Low Level Laser Therapy, Post operative pain control, TKA
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightForce XLIDevice
Also called LTS-1000, LTS-1500, LTS-2500, LTS-4000
The LightForce XLi laser is FDA cleared to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
The specific use of this device to decrease post-operative pain and improve function may be considered an off-label use. However, it is important to note that the off-label use of this device in the context of this study does not alter the fundamental safety or performance profile of the device in participants. This device (and other substantially equivalent devices) is commonly used in clinical practice in a rehabilitation setting to treat post-operative conditions and several studies have demonstrated safety and efficacy in post-operative use.
| Study group | Role | What they receive |
|---|---|---|
| PBMT Treatment | Experimental | first treatment (day of surgery in the PACU prior to discharge/transfer) and the treatments given in the first week, use 6 J/cm2, 6 W. For the second week of treatments, use 6 J/cm2, 15 W. Receives: Device: LightForce XLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS
In this pilot trial, the primary objective is to assess the efficacy of PBMT as an adjunct in a post-operative pain regiment utilized after a total knee arthroplasty in patients that are discharged the same day compared to matched historical control patients who also received a TKA and were discharged the same day as measured by the PROMIS NRS. Scale of 0 (no pain) - 10 (worst pain imaginable).
Measured: Each participant will complete all visits by 90 days from the date of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Model description
- To minimize bias when using historical controls, patients will be carefully matched on age, BMI, comorbidity profile, and surgical technique. Historical data will be abstracted using standardized chart review forms by blinded assessors, and sensitivity analyses will be conducted to confirm comparability. For our statistical plan, descriptive measures will initially be performed: categorical variables will be summarized by frequency counts along with associated percentages. Continuous variables will be summarized descriptively using number of subjects, mean, standard deviation, minimum, median, and maximum. Considering this a pilot trial we will not run a power analysis and no hypothesis testing will be performed. We estimate based on previous studies that a total intervention population of 15 patients compared to 15 patients matched by the historical patient population (total of 30 patients for this clinical trial) should be adequate to assess descriptive statistics.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Burney, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Enovis
- Responsible party
- Sponsor-investigator, Mohammad Burney, MD, North Texas Medical Research Institute, PLLC
- Investigators
- Mohammed U Burney, MD, Principal investigator, North Texas Medical Research Institute, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750912
- Sponsor's protocol ID
- 84391
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Future Use of Data Data collected for this study will be analyzed and stored at the principal investigators site. After the study is completed, the de-identified, archived data will be transmitted to and stored for use by other researchers including those outside of the study. Permission to perform future analyses will be included in the informed consent. During the conduct of the study, an individual participant can choose to withdraw consent to have their de-identified data stored and utilized for future research.
Publications
Looney AL, Huntingford JL, Blaeser LL, Mann S. A randomized blind placebo-controlled trial investigating the effects of photobiomodulation therapy (PBMT) on canine elbow osteoarthritis. Can Vet J. 2018 Sep;59(9):959-966.
PubMed 30197438Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. Lasers Med Sci. 2016 Jan;31(1):127-35. doi: 10.1007/s10103-015-1840-4. Epub 2015 Nov 26.
PubMed 26610637Langella F, et al. Photobiomodulation after joint arthroplasty reduces pain and opioid use. Lasers in Medical Science. 2018.
Huang Z, et al. Photobiomodulation improves functional recovery after joint arthroplasty. Clinical Rehabilitation. 2022
Bjordal JM, et al. A systematic review of low-level laser therapy for musculoskeletal pain. BMJ. 2006;332(7547):912-916
Bahrami H, Moharrami A, Mirghaderi P, Mortazavi SMJ. Low-Level Laser and Light Therapy After Total Knee Arthroplasty Improves Postoperative Pain and Functional Outcomes: A Three-Arm Randomized Clinical Trial. Arthroplast Today. 2022 Dec 5;19:101066. doi: 10.1016/j.artd.2022.10.016. eCollection 2023 Feb.
PubMed 36507283Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.
PubMed 34654554
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07750912
- Acronym / sponsor ID
- 84391
- Keywords
- Low Level Laser Therapy, Post operative pain control, TKA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mohammad Burney, MDUniversity, hospital or other
- Collaborators
- Enovis
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Aug 2026 (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.
A pilot study to assess the efficacy and feasibility of PBMT for pain control in patients undergoing a TKA and are discharged the same day from an ambulatory surgery center.
Detailed description
Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgeries in the United States, with the volume of procedures steadily rising due to an aging population and the growing prevalence of osteoarthritis. Given the shift toward outpatient settings and same-day discharges, effective postoperative pain management has become increasingly crucial for successful recovery in TKA patients.
Traditional pain management strategies in TKA, including nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, often begin perioperatively as part of a multimodal approach. Although NSAIDs and opioids can effectively reduce pain, they carry significant risks. Opioids are associated with dependency, respiratory depression, and other adverse effects, while NSAIDs pose risks of gastrointestinal bleeding, renal impairment, and cardiovascular complications. This creates a pressing need for alternative, non-pharmacological methods of pain management, particularly for patients discharged on the same day who must manage pain effectively without excessive reliance on opioids.
PBMT has emerged as a promising adjunct in managing postoperative pain. PBMT involves applying light in the red to near-infrared spectrum, which penetrates tissue, stimulating cellular processes that can reduce inflammation and promote healing. Mechanistically, PBMT enhances mitochondrial activity, increasing adenosine triphosphate (ATP) production, modulating reactive oxygen species (ROS), and upregulating transcription factors related to anti-inflammatory effects. This non-invasive therapy has shown efficacy in reducing pain and inflammation in various musculoskeletal and postoperative contexts.
Although PBMT has been widely applied in managing chronic pain and inflammation, its use in immediate postoperative care for patients undergoing same-day discharge TKA has not been evaluated. Given its potential to reduce pain without the risks associated with pharmacologic therapies, PBMT may provide a valuable addition to pain management protocols in TKA.
The primary aim of this clinical trial is to evaluate the feasibility and effectiveness of PBMT in managing postoperative pain for patients undergoing TKA with same-day discharge. Pain will be assessed through PROMIS pain measures, opioid usage in morphine milligram equivalents (MME), and additional parameters related to recovery and function, including the Knee Osteoarthritis Outcome Score (KOOS) and range of motion (ROM). The trial will explore whether PBMT can decrease reliance on opioids, improve functional outcomes, and offer a safer, more sustainable pain management strategy for TKA patients in outpatient settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To minimize bias when using historical controls, patients will be carefully matched on age, BMI, comorbidity profile, and surgical technique. Historical data will be abstracted using standardized chart review forms by blinded assessors, and sensitivity analyses will be conducted to confirm comparability. For our statistical plan, descriptive measures will initially be performed: categorical variables will be summarized by frequency counts along with associated percentages. Continuous variables will be summarized descriptively using number of subjects, mean, standard deviation, minimum, median, and maximum. Considering this a pilot trial we will not run a power analysis and no hypothesis testing will be performed. We estimate based on previous studies that a total intervention population of 15 patients compared to 15 patients matched by the historical patient population (total of 30 patients for this clinical trial) should be adequate to assess descriptive statistics.
| Arm | Type | Receives |
|---|---|---|
| PBMT Treatment | Experimental | Device: LightForce XLIfirst treatment (day of surgery in the PACU prior to discharge/transfer) and the treatments given in the first week, use 6 J/cm2, 6 W. For the second week of treatments, use 6 J/cm2, 15 W. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI less than or equal to 45
- Currently set up for an elective primary total knee arthroplasty due to primary osteoarthritis
- Ability to provide informed consent to participate in the clinical trial
- Ability to understand and communicate in English
- Willingness to comply with all study procedures
Key exclusion criteria (17 listed)
- poorly controlled comorbidities that would not allow surgical intervention such as poorly controlled diabetes (HbA1C > 8.0) renal insufficiency (eGFR <60) poorly controlled CV disease such as CHF that is NYHA class 3 and 4
- inability to receive the intervention including contraindications and/or known photosensitivity.
- patients with history of total joint infection ever or any infection in the last 6 months
- ASA score >3 and Outpatient Arthroplasty Risk Assessment (OARA; medical risk stratification scoring system to help determine day surgery vs inpatient)1 score > 80.
- previous PBMT treatment within 3 months from the start of the study for the participant.
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 |
|---|---|---|
| LightForce XLIAlso: LTS-1000, LTS-1500, LTS-2500, LTS-4000The LightForce XLi laser is FDA cleared to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. The specific use of this device to decrease post-operative pain and improve function may be considered an off-label use. However, it is important to note that the off-label use of this device in the context of this study does not alter the fundamental safety or performance profile of the device in participants. This device (and other substantially equivalent devices) is commonly used in clinical practice in a rehabilitation setting to treat post-operative conditions and several studies have demonstrated safety and efficacy in post-operative use. | Device | PBMT Treatment |
Primary outcome
Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS
Time frame: Each participant will complete all visits by 90 days from the date of surgery.
In this pilot trial, the primary objective is to assess the efficacy of PBMT as an adjunct in a post-operative pain regiment utilized after a total knee arthroplasty in patients that are discharged the same day compared to matched historical control patients who also received a TKA and were discharged the same day as measured by the PROMIS NRS. Scale of 0 (no pain) - 10 (worst pain imaginable).
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 6 Aug 2026.
- Background: PubMed 30197438Looney AL, Huntingford JL, Blaeser LL, Mann S. A randomized blind placebo-controlled trial investigating the effects of photobiomodulation therapy (PBMT) on canine elbow osteoarthritis. Can Vet J. 2018 Sep;59(9):959-966.
- Background: PubMed 26610637Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. Lasers Med Sci. 2016 Jan;31(1):127-35. doi: 10.1007/s10103-015-1840-4. Epub 2015 Nov 26.
- BackgroundLangella F, et al. Photobiomodulation after joint arthroplasty reduces pain and opioid use. Lasers in Medical Science. 2018.
- BackgroundHuang Z, et al. Photobiomodulation improves functional recovery after joint arthroplasty. Clinical Rehabilitation. 2022
- BackgroundBjordal JM, et al. A systematic review of low-level laser therapy for musculoskeletal pain. BMJ. 2006;332(7547):912-916
- Background: PubMed 36507283Bahrami H, Moharrami A, Mirghaderi P, Mortazavi SMJ. Low-Level Laser and Light Therapy After Total Knee Arthroplasty Improves Postoperative Pain and Functional Outcomes: A Three-Arm Randomized Clinical Trial. Arthroplast Today. 2022 Dec 5;19:101066. doi: 10.1016/j.artd.2022.10.016. eCollection 2023 Feb.
- Background: PubMed 34654554Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.
- Ahmad MA, Hamid MSA, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis.Link provided by the sponsor.
- Low-level laser and light therapy after total knee arthroplasty improves postoperative pain and functional outcomes: a three-arm randomized clinical trial. Arthroplasty TodayLink provided by the sponsor.
- Looney AL, Huntingford JL, Blaeser LL, Mann S. A randomized blind placebo-controlled trial investigating the effects of photobiomodulation therapy (PBMT) on canine elbow osteoarthritis.Link provided by the sponsor.
- Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Future Use of Data Data collected for this study will be analyzed and stored at the principal investigators site. After the study is completed, the de-identified, archived data will be transmitted to and stored for use by other researchers including those outside of the study. Permission to perform future analyses will be included in the informed consent. During the conduct of the study, an individual participant can choose to withdraw consent to have their de-identified data stored and utilized for future research.
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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.
Mohammed U Burney, MD principal investigator
North Texas Medical Research Institute, PLLC
Questions about this trial
What is this clinical trial studying?
A study testing LightForce XLI in people with Pain Management and TKA, run by Mohammad Burney, MD.
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 17 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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Jeffrey Neumann, Certified Physician Assistant (972-503-9495, jsn.ntmri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain in patients discharged same day from an ASC after a TKA as measured by the PROMIS NRS (time frame: Each participant will complete all visits by 90 days from the date of surgery.). 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 NCT07750912, which also lists 7 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 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.