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NCT Number: NCT07209891

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

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.

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Key information

Conditions

Hypertrophic Scar Burn Scar (Post-burn) Burns Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huda Badr Abd Elhamed

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged between 10 and 30 years. Presence of clinically diagnosed hypertrophic scars secondary to burn injuries, occurring between two months and four years after complete wound healing No history of other systemic or local pathologies that could affect scar characteristics or response to treatment. Ability and willingness to comply with the treatment protocol and attend all scheduled sessions

Exclusion criteria

  • Open wounds or ulceration at or near the scarred area. Systemic medical conditions such as uncontrolled diabetes mellitus, cardiovascular disease, or a history of skin malignancy in the treatment region. Diagnosed deep vein thrombosis (DVT).Non-adherence, unwillingness to participate, or inability to follow the protocol. Cognitive impairment, psychiatric illness, or communication barriers affecting informed consent or participation.

Treatment and study plan

Kinesio Tape

Device

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.

Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As

Device

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.

Standardized Scar Care (concomitant for all arms)

Other

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).

Primary outcomes

  1. Schiotz Tonometer

    Time frame: Baseline (Week 0) ,Week 8.

    The Riester Schiotz tonometer is used as an objective tool to assess hypertrophic scar elasticity The device displayed readings on a scale from 0 to 20. Indentation values were then converted to millimeters of mercury (mmHg) using a standardized conversion chart provided with the device

Secondary outcomes

  1. 2. Pain Assessment by Visual Analogue Scale (VAS)

    Time frame: Baseline (Week 0) , Week 8.

    Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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