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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kinesio tape | Experimental | Kinesiotape was used to cover the full extent of the scar tissue |
|
| 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. |
|
| kinesio tape and lowlevel laser | Experimental | combined treatment of low-level laser and kinesio tape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2. Pain Assessment by Visual Analogue Scale (VAS) | 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 | Baseline (Week 0) , Week 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huda Badr Abd Elhamed | Cairo | Egypt |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D002056 | Burns |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055052 | Athletic Tape |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
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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
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| 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). |
|
| D014947 |
| Wounds and Injuries |
| D013523 |
| Surgical Equipment |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |