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

NCT07209891 | Completed DMC

• 1 other identifier: National institute of laser
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypertrophic Scar; Burn; Kinesio Taping; VAS; Schiotz Tonometer; Photobiomodulation.; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Schiotz Tonometer

  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

  Baseline (Week 0) ,Week 8.

Secondary Outcomes (1)

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

  Baseline (Week 0) , Week 8.

Study Arms (3)

kinesio tape

EXPERIMENTAL

Kinesiotape was used to cover the full extent of the scar tissue

Device: Kinesio Tape; Other: Standardized Scar Care (concomitant for all arms)

low-level laser

EXPERIMENTAL

Giotto MED SPA-Italy-Ga-As low-level laser with the following parameters: wavelength 905 nm, energy density 16.2 J/cm2, pulsed mode with frequency 3000 Hz, and max output power 30 W. The application technique was a circular cluster probe with three output beams that each produced 30 W of power. The length of therapy varies according on the size of the scar.

Device: Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As; Other: Standardized Scar Care (concomitant for all arms)

kinesio tape and lowlevel laser

EXPERIMENTAL

combined treatment of low-level laser and kinesio tape

Device: Kinesio Tape; Device: Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As; Other: Standardized Scar Care (concomitant for all arms)

Interventions

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.

kinesio tape; kinesio tape and lowlevel laser

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.

kinesio tape and lowlevel laser; low-level laser

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).

kinesio tape; kinesio tape and lowlevel laser; low-level laser

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Huda Badr Abd Elhamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Burns

Interventions

Athletic Tape; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Sixty male and female patients with post-burn hypertrophic scars, aged 10-30years, participated in this randomized controlled trial. Patients were randomly assigned to three equal groups: Group A received kinesio tape and medication, Group B received low level laser therapy and medication, and Group C received kinesio tape and low-level laser therapy

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 5, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 30, 2024
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)