Burns, Burn Scar (Post-burn), Hypertrophic Scar
Conditions
Keywords
Hypertrophic Scar, Burn, Kinesio Taping, VAS, Schiotz Tonometer, Photobiomodulation., Low-Level Laser Therapy
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.
Interventions
DEVICEKinesio 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.
DEVICELow-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.
OTHERStandardized 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
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schiotz Tonometer | 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
| Measure | Time frame | Description |
|---|---|---|
| 2. Pain Assessment by Visual Analogue Scale (VAS) | 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 |
Countries
Egypt
Outcome results
None listed