An interventional study of low-level laser therapy added to usual care. in Pain Alleviation, sponsored by Universidad Nacional de Colombia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Universidad Nacional de Colombia · Not applicable, Interventional, and Other
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 32 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Universidad Nacional de Colombia is the lead sponsor of 39 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
It begins with low-level laser therapy added to usual care, followed by a washout period and subsequent usual care.
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.
Other: low-level laser therapy added to usual care.
low-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).
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 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).
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
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).
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
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").
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
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).
Time frame: Continuously during each in-person procedure and at 24-hour post-procedure telephone follow-up across all 4 consultations.
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universidad Nacional de Colombia