Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07866716 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07866716
Lead Sponsor Universidad Nacional de Colombia
Collaborators: Ministry of Science, Technology and Innovation, Call for Proposals 15 by the Department of Guaviare.
Conditions
(from sponsor)
Pain Alleviation
Related terms Pain, Wounds and Injuries
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov