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.
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.
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).
Crossover
low-level laser therapy added to usual care.
Other interventionlow-level laser therapy added to usual care
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).
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).
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).
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").
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).
Click on the lead sponsor to view all of their trials.
Universidad Nacional de Colombia
Lead sponsor
Ministry of Science, Technology and Innovation
Collaborator
Call for Proposals 15 by the Department of Guaviare.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
