Pain AlleviationNCT07866716
Effectiveness of Laser Therapy for Pain Relief From Chronic Wounds in Adults in Guaviare
A study of Pain Alleviation, run by Universidad Nacional de Colombia.
Trial summary
Traditionally, the clinical management of chronic wounds has concentrated primarily on tissue closure, leaving persistent pain under-addressed. Discomfort during routine dressing changes is often worsened by tissue trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Alleviation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 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
- Adults aged 18 years or older.
- Presence of a chronic wound, operationally defined as any lesion that does not show a reduction of at least 20% in size after 2 weeks of documented optimal conventional treatment.
- Adults reporting a baseline score of ≥4 on the numerical pain scale for wound-related pain at the time of previous dressing removal. This threshold will be verified prior to treatment sequence assignment.
- Voluntary agreement to participate and signing of the informed consent form.
Who cannot join
- Individuals who decide to withdraw from the study at any time.
- Individuals scheduled for surgery within the next 7 to 15 days.
- Individuals with psychiatric or neurological diagnoses that interfere with higher-level cognitive function, preventing comprehension of informed consent and the ability to provide the self-reports necessary for data collection.
- Adults with malignant neoplastic wounds (an absolute contraindication for LLLT due to the risk of cellular biostimulation).
- Adults with wounds suspected of malignancy.
- Women of childbearing potential with wounds in the abdominal region (as a precaution against possible undiagnosed pregnancy, due to a direct contraindication for low-level laser therapy).
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- Adults currently undergoing treatment with, or who have used, photosensitizing drugs (topical in the target area or systemic) within the 90 days prior to the intervention (due to a direct contraindication regarding light exposure during low-level laser therapy).
- Adults who have used topical dermatological treatments containing vitamin A-derived acids (retinol, retinoic acid, or derivatives) on the target area within the previous 15 days (due to a direct contraindication regarding light exposure during low-level laser therapy).
- Documented history of photosensitivity or adverse reactions to light-based therapies.
- Adults who have experienced direct mechanical trauma (blows or falls) to the wound area within the 48 hours prior to the intervention, resulting in an atypical increase in baseline pain.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yesly J Rincon T, BSN, RN, MSN, PHD(c) contact
About this study
Traditionally, the clinical management of chronic wounds has concentrated primarily on tissue closure, leaving persistent pain under-addressed. Discomfort during routine dressing changes is often worsened by tissue trauma. Even with standard pain medications and gentle dressing procedures, patients in Guaviare, Colombia, continue to suffer from unmet pain management needs. To bridge this gap, Low-Level Laser Therapy (photobiomodulation) offers a nurse-driven, non-pharmacological complementary option designed to target pain directly and enhance overall quality of life.
This research aims to evaluate the effectiveness of low-level laser therapy added to standard care, compared to standard care alone, for the relief of pain experienced by patients with chronic wounds during nursing consultations at a wound care clinic in a healthcare institution in San José del Guaviare, Colombia.
Read more
The study employs a pragmatic randomized crossover design (AB/BA), enabling each participant to serve as their own control and increasing statistical efficiency. Participants will randomly receive both treatments-laser therapy combined with usual care, as well as usual care on its own-separated by a four-day washout period.
Key evaluation criteria include decreases in pain intensity and its interference with daily activities, alongside gains in perceived pain relief and overall patient satisfaction. The resulting data will be evaluated using Linear Mixed Models, analyzing the cohort through complementary Intention-to-Treat (ITT) and Per-Protocol (PP) framework approaches.
- Conditions
- Pain Alleviation
- Being tested
- low-level laser therapy added to usual care.
- Keywords
- wounds and injuries, pain, low-level laser therapy, stomatherapy, photobiomodulation
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser therapy added to usual care.Other
low-level laser therapy added to usual care
| Study group | Role | What they receive |
|---|---|---|
| AB | Other | It begins with low-level laser therapy added to usual care, followed by a washout period and subsequent usual care. Receives: Other: low-level laser therapy added to usual care. |
| BA | Other | It begins with usual care, followed by a washout period and subsequent low-level laser therapy added to usual care. Receives: Other: low-level laser therapy added to usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Pre-Procedure to Post-Procedure in Pain Intensity Score on the Brief Pain Inventory Short Form (BPI-SF) Numeric Rating Scale
Pain intensity evaluated using the Numeric Rating Scale (NRS) component of the Brief Pain Inventory Short Form (BPI-SF) / Cuestionario Breve del Dolor - Forma Corta (CBD-FC). The scale ranges from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores represent a worse outcome (greater pain severity). A reduction of at least 2 points is defined as the Minimally Clinically Important Difference (MCID).
Measured: Evaluated pre-procedure (upon removal of previous dressing), intra-procedure, immediate post-procedure, and at 24-hour post-procedure telephone follow-up during each of the 4 nursing consultations in the crossover study.
Secondary outcomes (4)
Pain Interference Score on the Brief Pain Inventory Short Form (BPI-SF)
Impact of pain on daily functioning across 7 items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) using the Pain Interference Subscale of the Brief Pain Inventory Short Form (BPI-SF). Each item is scored on an 11-point numeric rating scale ranging from 0 ("does not interfere") to 10 ("completely interferes"). The outcome is reported as the mean interference score across the 7 items (range 0 to 10). Higher scores represent a worse outcome (greater functional interference).
Measured: Baseline and 24 hours post-procedure following each of the 4 nursing consultations in the crossover study.
Proportion of Participants Reporting Pain Improvement on a Single-Item Categorical Scale
Participant's immediate perception of change in pain severity post-procedure, evaluated through a single-item categorical question with three mutually exclusive responses: "Improved", "Remained the same", or "Worsened". Reported as the percentage of participants selecting the "Improved" category, which represents a better outcome (clinical success).
Measured: Immediately at consultation closure and at 24-hour post-procedure telephone follow-up for each of the 4 consultations
Participant Satisfaction Score on an Ad Hoc 5-Point Likert Scale
Subjective evaluation of participant satisfaction regarding nursing care interventions for pain relief, measured on an ad hoc 5-point Likert Scale. Response categories range from 1 ("Very Unsatisfied") to 5 ("Very Satisfied"). Higher scores represent a better outcome (greater satisfaction). Treatment success is defined as scores of 4 ("Satisfied") or 5 ("Very Satisfied").
Measured: Evaluated immediately at the end of each nursing consultation, across all 4 consultations.
Number of Participants With Treatment-Related Adverse Events as Assessed
Active surveillance of adverse events (e.g., mild erythema, transient pain increase, heat sensation, blistering, photosensitivity) assessed. Reported as the total count and percentage of participants who experience at least one adverse event categorized by severity (Grade 1/Mild, Grade 2/Moderate, Grade 3+/Severe). Lower counts represent a better outcome (greater intervention safety).
Measured: Continuously during each in-person procedure and at 24-hour post-procedure telephone follow-up across all 4 consultations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain AlleviationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A pragmatic, randomized, crossover (AB/BA) clinical trial will be conducted involving adults with chronic wounds and pain. This design allows each participant to serve as their own control, thereby maximizing statistical efficiency. Subjects will be randomly assigned to receive either low-level laser therapy (photobiomodulation) in addition to standard care or standard care alone, with a four-day washout period between interventions. The study outcomes include reducing pain intensity and the impact of pain on daily life, as well as improving the perception of relief and satisfaction regarding pain relief. Analysis will be performed using Linear Mixed Models, employing both Intention-to-Treat (ITT) and Per-Protocol (PP) approaches in a complementary manner.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science, Technology and Innovation, Call for Proposals 15 by the Department of Guaviare.
- Responsible party
- Principal investigator, Sandra Guerrero Gamboa, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866716
- Sponsor's protocol ID
- 023-26
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taha N, Daoud H, Malik T, Shettysowkoor J, Rahman S. The Effects of Low-Level Laser Therapy on Wound Healing and Pain Management in Skin Wounds: A Systematic Review and Meta-Analysis. Cureus. 2024 Oct 28;16(10):e72542. doi: 10.7759/cureus.72542. eCollection 2024 Oct.
PubMed 39610644European Wound Management Association. (2023). Palliative wound care. https://ewma.org/upcoming-resources/palliative-wound-care/
Clijsen R, Brunner A, Barbero M, Clarys P, Taeymans J. Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2017 Aug;53(4):603-610. doi: 10.23736/S1973-9087.17.04432-X. Epub 2017 Jan 30.
PubMed 28145397Chittoria, R., & Kumar, S. (2018). Low-level laser therapy (LLLT) in wound healing. En Current Concept in Advanced Wound Care (pp. 21-26). Springer. https://doi.org/10.1007/15695_2017_89
Bagheri M, Mostafavinia A, Abdollahifar MA, Amini A, Ghoreishi SK, Chien S, Hamblin MR, Bayat S, Bayat M. Combined effects of metformin and photobiomodulation improve the proliferation phase of wound healing in type 2 diabetic rats. Biomed Pharmacother. 2020 Mar;123:109776. doi: 10.1016/j.biopha.2019.109776. Epub 2020 Jan 3.
PubMed 31911295
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Laser Therapy for Pain Relief From Chronic Wounds in Adults in Guaviare
- ClinicalTrials.gov ID
- NCT07866716
- Acronym / sponsor ID
- 023-26
- Conditions
- Pain Alleviation
- Keywords
- wounds and injuries, pain, low-level laser therapy, stomatherapy, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Collaborators
- Ministry of Science, Technology and Innovation, Call for Proposals 15 by the Department of Guaviare.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Oct 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.
Traditionally, the clinical management of chronic wounds has concentrated primarily on tissue closure, leaving persistent pain under-addressed. Discomfort during routine dressing changes is often worsened by tissue trauma. Even with standard pain medications and gentle dressing procedures, patients in Guaviare, Colombia, continue to suffer from unmet pain management needs. To bridge this gap, Low-Level Laser Therapy (photobiomodulation) offers a nurse-driven, non-pharmacological complementary option designed to target pain directly and enhance overall quality of life.
This research aims to evaluate the effectiveness of low-level laser therapy added to standard care, compared to standard care alone, for the relief of pain experienced by patients with chronic wounds during nursing consultations at a wound care clinic in a healthcare institution in San José del Guaviare, Colombia.
The study employs a pragmatic randomized crossover design (AB/BA), enabling each participant to serve as their own control and increasing statistical efficiency. Participants will randomly receive both treatments-laser therapy combined with usual care, as well as usual care on its own-separated by a four-day washout period.
Key evaluation criteria include decreases in pain intensity and its interference with daily activities, alongside gains in perceived pain relief and overall patient satisfaction. The resulting data will be evaluated using Linear Mixed Models, analyzing the cohort through complementary Intention-to-Treat (ITT) and Per-Protocol (PP) framework approaches.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic, randomized, crossover (AB/BA) clinical trial will be conducted involving adults with chronic wounds and pain. This design allows each participant to serve as their own control, thereby maximizing statistical efficiency. Subjects will be randomly assigned to receive either low-level laser therapy (photobiomodulation) in addition to standard care or standard care alone, with a four-day washout period between interventions. The study outcomes include reducing pain intensity and the impact of pain on daily life, as well as improving the perception of relief and satisfaction regarding pain relief. Analysis will be performed using Linear Mixed Models, employing both Intention-to-Treat (ITT) and Per-Protocol (PP) approaches in a complementary manner.
| Arm | Type | Receives |
|---|---|---|
| AB | Other | Other: low-level laser therapy added to usual care.It begins with low-level laser therapy added to usual care, followed by a washout period and subsequent usual care. |
| BA | Other | Other: low-level laser therapy added to usual care.It begins with usual care, followed by a washout period and subsequent low-level laser therapy added to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Presence of a chronic wound, operationally defined as any lesion that does not show a reduction of at least 20% in size after 2 weeks of documented optimal conventional treatment.
- Adults reporting a baseline score of ≥4 on the numerical pain scale for wound-related pain at the time of previous dressing removal. This threshold will be verified prior to treatment sequence assignment.
- Voluntary agreement to participate and signing of the informed consent form.
Key exclusion criteria (10 listed)
- Individuals who decide to withdraw from the study at any time.
- Individuals scheduled for surgery within the next 7 to 15 days.
- Individuals with psychiatric or neurological diagnoses that interfere with higher-level cognitive function, preventing comprehension of informed consent and the ability to provide the self-reports necessary for data collection.
- Adults with malignant neoplastic wounds (an absolute contraindication for LLLT due to the risk of cellular biostimulation).
- Adults with wounds suspected of malignancy.
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 |
|---|---|---|
| low-level laser therapy added to usual care.low-level laser therapy added to usual care | Other | AB, BA |
Primary outcome
Change From Pre-Procedure to Post-Procedure in Pain Intensity Score on the Brief Pain Inventory Short Form (BPI-SF) Numeric Rating Scale
Time frame: Evaluated pre-procedure (upon removal of previous dressing), intra-procedure, immediate post-procedure, and at 24-hour post-procedure telephone follow-up during each of the 4 nursing consultations in the crossover study.
Pain intensity evaluated using the Numeric Rating Scale (NRS) component of the Brief Pain Inventory Short Form (BPI-SF) / Cuestionario Breve del Dolor - Forma Corta (CBD-FC). The scale ranges from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores represent a worse outcome (greater pain severity). A reduction of at least 2 points is defined as the Minimally Clinically Important Difference (MCID).
4 secondary outcomes
Pain Interference Score on the Brief Pain Inventory Short Form (BPI-SF)
Time frame: Baseline and 24 hours post-procedure following each of the 4 nursing consultations in the crossover study.
Proportion of Participants Reporting Pain Improvement on a Single-Item Categorical Scale
Time frame: Immediately at consultation closure and at 24-hour post-procedure telephone follow-up for each of the 4 consultations
Participant Satisfaction Score on an Ad Hoc 5-Point Likert Scale
Time frame: Evaluated immediately at the end of each nursing consultation, across all 4 consultations.
Number of Participants With Treatment-Related Adverse Events as Assessed
Time frame: Continuously during each in-person procedure and at 24-hour post-procedure telephone follow-up across all 4 consultations.
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 8 Oct 2026.
- Background: PubMed 39610644Taha N, Daoud H, Malik T, Shettysowkoor J, Rahman S. The Effects of Low-Level Laser Therapy on Wound Healing and Pain Management in Skin Wounds: A Systematic Review and Meta-Analysis. Cureus. 2024 Oct 28;16(10):e72542. doi: 10.7759/cureus.72542. eCollection 2024 Oct.
- BackgroundEuropean Wound Management Association. (2023). Palliative wound care. https://ewma.org/upcoming-resources/palliative-wound-care/
- Background: PubMed 28145397Clijsen R, Brunner A, Barbero M, Clarys P, Taeymans J. Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2017 Aug;53(4):603-610. doi: 10.23736/S1973-9087.17.04432-X. Epub 2017 Jan 30.
- BackgroundChittoria, R., & Kumar, S. (2018). Low-level laser therapy (LLLT) in wound healing. En Current Concept in Advanced Wound Care (pp. 21-26). Springer. https://doi.org/10.1007/15695_2017_89
- Results publication: PubMed 31911295Bagheri M, Mostafavinia A, Abdollahifar MA, Amini A, Ghoreishi SK, Chien S, Hamblin MR, Bayat S, Bayat M. Combined effects of metformin and photobiomodulation improve the proliferation phase of wound healing in type 2 diabetic rats. Biomed Pharmacother. 2020 Mar;123:109776. doi: 10.1016/j.biopha.2019.109776. Epub 2020 Jan 3.
- 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.
Yesly J Rincon T, BSN, RN, MSN, PHD(c) contact
Questions about this trial
What is this clinical trial studying?
A study of Pain Alleviation, run by Universidad Nacional de Colombia.
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 4 inclusion and 10 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 8 Oct 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 Yesly J Rincon T, BSN, RN, MSN, PHD(c) (56 (601) 3165000 ext. 7011 -17086, yjrincont@unal.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-Procedure to Post-Procedure in Pain Intensity Score on the Brief Pain Inventory Short Form (BPI-SF) Numeric Rating Scale (time frame: Evaluated pre-procedure (upon removal of previous dressing), intra-procedure, immediate post-procedure, and at 24-hour post-procedure telephone follow-up during each of the 4 nursing consultations in the crossover study.). 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 NCT07866716, which also lists 5 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 8 Oct 2026.