COMPARISON STUY OF KINESIOTAPE AND LOW-LEVEL LASER THERAPY ON HYPERTROPHIC SCAR
NCT07209891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-10-07
Summary
Hypertrophic scars after burn injury often cause pain, stiffness, and cosmetic concerns. Kinesio taping (KT) and low-level laser therapy (LLLT; photobiomodulation) are widely used, yet direct comparisons and combined-therapy data remain limited. This single-center, three-arm, parallel randomized controlled trial will compare KT alone, LLLT alone, and their combination in patients with post-burn hypertrophic scars. Sixty participants will be randomized (1:1:1) to receive KT (reapplied every 2-3 days), LLLT using a 905-nm pulsed device (three sessions per week), or KT+LLLT for 8 weeks; all groups receive standardized scar care. Outcome assessors will be blinded. The primary outcome is change in scar pliability/firmness measured with a modified Schiotz tonometer from baseline to week 8. Secondary outcomes include change in pain intensity on a 10-cm visual analogue scale and treatment-related adverse events; an optional assessment at week 12 will evaluate durability. We hypothesize that KT+LLLT will produce greater improvements in elasticity and pain than either modality alone. The trial will be conducted at the Faculty of Physical Therapy, Cairo University (Giza, Egypt). Sponsor: Cairo University; Collaborators: National Institute of Laser Enhanced Sciences (NILES) and Faculty of Physical Therapy.
Conditions
- Hypertrophic Scar
- Burn Scar (Post-burn)
- Burns
Interventions
- DEVICE
-
Kinesio Tape
Cotton elastic tape applied along the full length/width of the target hypertrophic scar with \~25-50% stretch while the scar is on gentle lengthening. Continuous wear; replaced every 2-3 days.
- DEVICE
-
Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As
Fluence 16.2 J/cm² at skin; pulse frequency 3000 Hz; session duration \~15 min at standardized distance (\~10 cm) using an orange medical filter; protective eyewear for patient and staff.
- OTHER
-
Standardized Scar Care (concomitant for all arms)
Uniform background care applied across all groups; recorded in CRFs; prohibited co-interventions (e.g., intralesional steroids, microneedling, ablative lasers, new pressure garments during the study).
Sponsors & Collaborators
-
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-05
- Primary Completion
- 2024-12-12
- Completion
- 2024-12-30
Countries
- Egypt
Study Locations
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