[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659503":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":40,"interventions":50,"overallOfficials":30,"centralContacts":55,"locations":30,"responsibleParty":62,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":30,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":95,"whyStopped":30,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":30},{"fullName":5,"class":6},"Universidad Nacional de Colombia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"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) \u002F 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).","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.",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"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).","Baseline and 24 hours post-procedure following each of the 4 nursing consultations in the crossover study.",{"measure":19,"description":20,"timeFrame":21},"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).","Immediately at consultation closure and at 24-hour post-procedure telephone follow-up for each of the 4 consultations",{"measure":23,"description":24,"timeFrame":25},"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\").","Evaluated immediately at the end of each nursing consultation, across all 4 consultations.",{"measure":27,"description":28,"timeFrame":29},"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\u002FMild, Grade 2\u002FModerate, Grade 3+\u002FSevere). Lower counts represent a better outcome (greater intervention safety).","Continuously during each in-person procedure and at 24-hour post-procedure telephone follow-up across all 4 consultations.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":6,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","CROSSOVER","A pragmatic, randomized, crossover (AB\u002FBA) 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":36,"maskingDescription":37,"whoMasked":38},"SINGLE","The statistical analysis will be conducted in a blinded manner. The statistician will receive a coded database containing no explicit information regarding the sequence or interventions. This ensures that the analysis is performed objectively, free from the influence of prior knowledge concerning the intervention applied in each sequence.",[39],"OUTCOMES_ASSESSOR",[41,46],{"label":42,"type":6,"description":43,"interventionNames":44},"AB","It begins with low-level laser therapy added to usual care, followed by a washout period and subsequent usual care.",[45],"Other: low-level laser therapy added to usual care.",{"label":47,"type":6,"description":48,"interventionNames":49},"BA","It begins with usual care, followed by a washout period and subsequent low-level laser therapy added to usual care.",[45],[51],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":30},"low-level laser therapy added to usual care.","low-level laser therapy added to usual care",[42,47],[56],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Yesly J Rincon T, BSN, RN, MSN, PHD(c)","CONTACT","56 (601) 3165000","7011 -17086","yjrincont@unal.edu.co",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Sandra Guerrero Gamboa","PhD",[67,70],{"name":68,"class":69},"Ministry of Science, Technology and Innovation","UNKNOWN",{"name":71,"class":69},"Call for Proposals 15 by the Department of Guaviare.","100659503","effectiveness-of-laser-therapy-for-pain-relief-from-chronic-wounds-in-adults-in-guaviare-100659503",false,"NCT07866716","Effectiveness of Laser Therapy for Pain Relief From Chronic Wounds in Adults in Guaviare","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* 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.\n* 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.\n* Voluntary agreement to participate and signing of the informed consent form.\n\nExclusion Criteria:\n\n* Individuals who decide to withdraw from the study at any time.\n* Individuals scheduled for surgery within the next 7 to 15 days.\n* 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.\n* Adults with malignant neoplastic wounds (an absolute contraindication for LLLT due to the risk of cellular biostimulation).\n* Adults with wounds suspected of malignancy.\n* 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).\n* 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).\n* 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).\n* Documented history of photosensitivity or adverse reactions to light-based therapies.\n* 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.","ALL","18 Years",{"count":81,"type":82},32,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.\n\nThis 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.\n\nThe study employs a pragmatic randomized crossover design (AB\u002FBA), 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.\n\nKey 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.",[88],"Pain Alleviation",[90,91,92,93,94],"wounds and injuries","pain","low-level laser therapy","stomatherapy","photobiomodulation","NOT_YET_RECRUITING","2026-10-05",{"date":98,"type":99},"2026-10-08","ACTUAL",{"date":101,"type":82},"2026-10",{"date":103,"type":82},"2027-07",{"name":5,"class":6}]