Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children

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 6 to 18 years
• All sexes
• No healthy volunteers
• Child, Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children

Conditions

Hand-burned Children

Being tested

physical therapy treatment, Botulinum toxin-A injection in addition to physical therapy program, shock wave therapy in addition to physical therapy program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• physical therapy treatmentOther

  The control group will receive the physical therapy program and conduct five times per week over four consecutive weeks under the supervision of a physical rehabilitation specialist. The primary focus of the program was to improve scar malleability, lengthen muscles and tendons, enhance joint mobility, and to restore functionality. Each session lasted almost for 45 minutes and consisted of therapeutic paraffin application; deep tissue massaging (5 minutes); stretching exercises; active ROM exercises.

• Botulinum toxin-A injection in addition to physical therapy programOther

  Two injection procedures will be used. The first is an EMG-guided BTX-A administration (Botox®, Allergan PLC, Dublin, Ireland) that will be localized to the motor endplate zone of the wrist flexors, radial and ulnar deviators. The second is a meso-injection procedure, where the BTX-A will be injected subdermal, intradermal, and into the scar (around the periphery and into the center).

• shock wave therapy in addition to physical therapy programOther

  After wound and skin graft healing (~ 90 days post-surgery), the unfocused shockwave will be applied to the site of burn injury on the volar aspect of the hand of the subjects and will allocate to the shock wave therapy intervention arm. The treatment will be delivered using a portable shockwave device (Zimmer enPuls, EMS physio Ltd, Germany).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Electronic goniometer

   to assess the range of motions of wrist extension, radial deviation, and ulnar deviation. Active ROM Measurement: the patient independently moving their affected joint. The device records the joint angle throughout the movement, allowing for a thorough assessment of functional limitations caused by hypertrophic scars. Passive ROM Measurement: the therapist moves the patient's joint through its range of motion while the electronic goniometer measures and records the joint angles. This approach provides valuable information about the degree of movement restriction due to hypertrophic scarring.

   Measured: 3 months

2. Hand grip Dynamometer

   for hand grip strength is used for assessing upper limb impairment, work capacity following injury or disease, and rehabilitation progression and/or potential following injury or surgery. For each child, the maximal voluntary contraction was determined as the highest of three contractions (INITIAL MAX). After a one-minute rest period, children will be instructed to squeeze the dynamometer in a static contraction at a level of 50% maximal for as long as possible, the duration of which will be recorded (DURATION). The level of static contraction will be monitored by the assessor who provided verbal feedback to ensure that a level of 50% maximal was maintained. Children must perform an additional post-fatigue maximal contraction within 10 seconds of completing the 50% maximal static contraction (FINAL MAX).

   Measured: 3 months

3. Vancouver scar scale

   It employs four main parameters to evaluate hypertrophic scars: vascularity, pigmentation, pliability, and height. These parameters are individually scored on a scale ranging from 0 to 3, with higher scores indicating greater severity. The scores are then summed to provide an overall measure of scar severity, ranging from 0 (normal skin) to 14 (most severe scar). To ensure accurate evaluations, it is recommended to have adequate lighting, a calm environment, and reliable observers trained in using the VSS. Evaluators carefully assess each parameter, considering factors such as erythema, texture, and skin tension to assign appropriate scores. Finally, the total score provides a comprehensive representation of the hypertrophic scar's severity.

   Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Dec 2023
2. Study start15 Dec 2023
3. Primary completion5 Mar 2024
4. Study completion20 Jun 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hand-burned ChildrenStudies 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.