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

NCT ID: NCT07209891

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2024-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

kinesio tape

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

Group Type: EXPERIMENTAL

Kinesio Tape

Intervention Type: 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.

Standardized Scar Care (concomitant for all arms)

Intervention Type: 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).

low-level laser

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Intervention Type: 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 and lowlevel laser

combined treatment of low-level laser and kinesio tape

Group Type: EXPERIMENTAL

Kinesio Tape

Intervention Type: 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

Intervention Type: 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)

Intervention Type: 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).

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Huda Badr Abd El Hamed

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huda Badr Abd Elhamed

Cairo, , Egypt

Countries

Egypt

Other Identifiers

National institute of laser

Identifier Type: -

Identifier Source: org_study_id