NCT07209891

COMPARISON STUY OF KINESIOTAPE AND LOW-LEVEL LASER THERAPY ON HYPERTROPHIC SCAR

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objective: Compare the effects of kinesio taping (KT), low-level laser therapy (LLLT), and their combination on pliability and pain of post-burn hypertrophic scars. Design: Single-center, three-arm, parallel randomized controlled trial (1:1:1); assessor- and analyst-blinded. Setting: Outpatient clinic, Faculty of Physical Therapy, Cairo University (Giza, Egypt). Participants: \~60 patients with clinically diagnosed hypertrophic scars after burns; able to complete 8-week treatment; standard exclusions for open wounds, infection, photosensitivity, etc. Interventions: Arm A: KT + standardized scar care (tape reapplied every 2-3 days). Arm B: LLLT (905-nm pulsed device; \~16.2 J/cm²; 3×/week). Arm C: KT + LLLT on the same schedule. Duration: 8-week treatment; optional week-12 follow-up for durability. Primary Outcome: Change in scar pliability/firmness (modified Schiotz tonometer) from baseline to week 8. Secondary Outcomes: Change in pain (10-cm VAS); treatment-related adverse events; optional week-12 persistence. Randomization/Concealment: Computer-generated sequence; SNOSE envelopes. Analysis: Intention-to-treat; linear mixed-effects models with adjusted pairwise contrasts (Holm/Bonferroni). Sponsor: Cairo University. Collaborators: National Institute of Laser Enhanced Sciences (NILES) and Faculty of Physical Therapy, Cairo University. Hypothesis: KT+LLLT will yield greater improvements than either modality alone.

Conditions

• Hypertrophic Scar
• Burn Scar (Post-burn)
• Burns

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-10-05
• Primary completion: 2024-12-12
• Completion: 2024-12-30
• First posted: 2025-10-07
• Last updated: 2025-10-07

Locations

1 site across 1 country: Egypt