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NCT07866716

Effectiveness of Laser Therapy for Pain Relief From Chronic Wounds in Adults in Guaviare

Sponsor: Universidad Nacional de Colombia

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2027-07

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Pain Alleviation

Interventions

OTHER

low-level laser therapy added to usual care.

low-level laser therapy added to usual care

Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.