Hypertrophic ScarNCT07209891
COMPARISON STUY OF KINESIOTAPE AND LOW-LEVEL LASER THERAPY ON HYPERTROPHIC SCAR
A study testing Kinesio Tape, Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As and Standardized Scar Care (concomitant for all arms) in people with Hypertrophic Scar and Burn Scar (Post-burn), run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scar, Burn Scar (Post-burn), Burns
- What is being tested?
- Kinesio Tape, Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As and Standardized Scar Care (concomitant for all arms)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Kinesio Tape, Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As, Standardized Scar Care (concomitant for all arms)
- Keywords
- Hypertrophic Scar, Burn, Kinesio Taping, VAS, Schiotz Tonometer, Photobiomodulation., Low-Level Laser Therapy
- Medical subject headings
- Cicatrix, Hypertrophic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeDevice
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-AsDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| kinesio tape | Experimental | Kinesiotape was used to cover the full extent of the scar tissue Receives: 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. Receives: 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 Receives: Device: Kinesio Tape; Device: Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As; Other: Standardized Scar Care (concomitant for all arms) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Week 0) ,Week 8.
Secondary outcomes (1)
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
Measured: Baseline (Week 0) , Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start5 Oct 2023
- Primary completion12 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Badr Abd El Hamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209891
- Sponsor's protocol ID
- National institute of laser
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON STUY OF KINESIOTAPE AND LOW-LEVEL LASER THERAPY ON HYPERTROPHIC SCAR
- ClinicalTrials.gov ID
- NCT07209891
- Acronym / sponsor ID
- National institute of laser
- Conditions
- Hypertrophic Scar, Burn Scar (Post-burn), Burns
- Keywords
- Hypertrophic Scar, Burn, Kinesio Taping, VAS, Schiotz Tonometer, Photobiomodulation., Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| kinesio tape | Experimental | Device: Kinesio Tape, Other: Standardized Scar Care (concomitant for all arms)Kinesiotape was used to cover the full extent of the scar tissue |
| low-level laser | Experimental | Device: Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As, Other: Standardized Scar Care (concomitant for all arms)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 | Device: Kinesio Tape, Device: Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As, Other: Standardized Scar Care (concomitant for all arms)combined treatment of low-level laser and kinesio tape |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio TapeCotton 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. | Device | kinesio tape, kinesio tape and lowlevel laser |
| Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-AsFluence 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. | Device | kinesio tape and lowlevel laser, low-level laser |
| 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). | Other | kinesio tape, kinesio tape and lowlevel laser, low-level laser |
Primary outcome
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
1 secondary outcome
2. Pain Assessment by Visual Analogue Scale (VAS)
Time frame: Baseline (Week 0) , Week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Yes
Related trials for Hypertrophic Scar
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tape, Low-Level Laser Therapy (LLLT), 905-nm pulsed Ga-As and Standardized Scar Care (concomitant for all arms) in people with Hypertrophic Scar and Burn Scar (Post-burn), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schiotz Tonometer (time frame: Baseline (Week 0) ,Week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.