Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients.
The main questions is it aims to answer is :
Subjects :
Sixty patients have hypertrophic scar post burn. They will be selected from El Gamaa hospital and randomly distributed into two equal groups. Their ages will be ranged from 20 to 45 years.
Design of the study :
In this study, the patients will be randomly divided into two equal groups in number (30 patients each).
Group A (pulsed high intensity laser group):
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive pulsed high intensity laser in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be three times per week.
Group B (Extracorporeal shockwave group):
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive Extracorporeal shockwave therapy in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be two times per week.
Equipments :
.Measurement equipments :
Modified Vancouver burn Scar assessment scale :
Modified Vancouver scar scale (VSS), an observer-dependent scale of the macroscopic appearance of scarring, was used to measure changes in the scar over the period of treatment.
The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin.To assess 3 variables of scar characteristics: Vascularity, pliability and height.
Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score)
A Schiotz tonometer scale :
This scale will be used as an objective scale to asses the hypertrophic scar pliability and elasticity.
The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar.
To assess scar pliability and elasticity improvement by an objective manner It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg .
Treatment procedure :
Pulsed High Intensity Laser application procedure:
Extracorporeal shockwave application procedure:
conservative treatment for both groups: (Stretching exercises and Deep friction massage ) 2 sessions per week for 6 weeks
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group receives pulsed high intensity laser and coservative treatment | Active Comparator |
| |
| study group receives extracorporeal shockwave therapy and coservative treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed high intensity laser therapy | Device | The high-intensity laser therapy (HILT), which involves laser radiation with high-intensity, is a kind of novel and powerful . The HILT possesses its own photomechanical, photothermal, and the photo-chemical properties. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Vancouver burn Scar assessment scale | Modified Vancouver scar scale , an observer-dependent scale of the macroscopic appearance of scarring, is used to measure changes in the scar over the period of treatment,The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin ,Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score). | change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Aschiotz tonometer device | Aschiotz tonometer device, will be used as an objective scale to asses the hypertrophic scar pliability and elasticity. The tissue tonometer provides a repeatable and objective index of burn scar pliability. it is a simple, clinically useful technique for monitoring an individual's scar It is held vertically at a measured point of the scar, so the plunger moved downwards by gravity and indent the scar tissue. The instrument gives a reading on a horizontal scale numbered arbitrarily from 0 to 20, but the device does not measure scar pressure directly, a conversion table, supplied with the Schiotz tonometer, is used to translate the instrument readings into measurements by mmHg. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amira Fayed Ali, Bachelor's | Contact | 01011172739 | fayedamira82@gmail.com | |
| Haidy Nady Ashem, professor | Contact | haidyjoj.hn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haidy Nady Ashem, professor | faculty of physical therapy | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35115845 | Result | Ruchiatan K, Suhada KU, Hindritiani R, Puspitosari D, Septrina R. Combination of 1064 nm Long-Pulsed and Q-Switched Nd:YAG Laser for Facial Hypertrophic Scar and Hyperpigmentation Following Burn Injury. Int Med Case Rep J. 2022 Jan 25;15:23-27. doi: 10.2147/IMCRJ.S348091. eCollection 2022. | |
| 32917473 | Result | Lee SY, Joo SY, Cho YS, Hur GY, Seo CH. Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study. Burns. 2021 Jun;47(4):821-827. doi: 10.1016/j.burns.2020.08.009. Epub 2020 Aug 29. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
Not provided
Not provided
Group A (30 patients receive pulsed high intensity laser plus taditional PT treatment for postburn hypertrophic scar.
Groyp B (30 patients recaive extracorporeal shockwave therapy plus traditional PT treatment for post burn hypertrophic scar.
Not provided
Not provided
Not provided
Not provided
| Extracorporeal shockwave therapy | Device | Extracorporeal shockwave therapy is an acoustic wave that mechanically disrupts tissue by cavitation.Shock waves develop microscopic injuries in scar tissue and break down collagen fibers which lead to scar remodelin .The patient is positioned in a comfortable position. The scar site is prepared with contact gel to conduct the shock waves, 30-50 shocks/cm2 , with an energy flux density of 0.25mJ/mm2 and a frequency of 6Hz. Each treatment region is covered with 2500 to 3000 impulses with an average session time of 10-15min . |
|
| change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment) |
| Related Info | View source |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |