JRCT ID: jRCTs051240240
Registered date:10/01/2025
A Study of the Combined Effects of Diffuse Pressure Wave and Botulinum Toxin Treatment on Adductor Spasticity in Spasticity Associated with Cerebral Palsy
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | spasticity associated with cerebral palsy |
Date of first enrollment | 10/01/2025 |
Target sample size | 10 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | The study period consists of a 0-4 week pre-observation period, a 12 week period of treatment with botulinum toxin alone, a 12 week period between treatments, and a 12 week period of combined treatment with botulinum toxin and diffuse pressure wave therapy. Patients will visit the hospital every 4 weeks during the period of treatment with botulinum toxin alone, and every 2 weeks during the period of combined treatment. Botulinum toxin treatment is administered by intramuscular injection into both adductor muscles once during the single treatment period and once at the start of combined treatment. The injection site for the greater adductor muscle is the midpoint on the line connecting the ischial tuberosity and the medial epicondyle of the femur, which is confirmed by palpation before administering the injection. The dose is 50 units of botulinum toxin A for each of the patient's adductor muscles (2 x body weight (kg) units for children weighing 25 kg or less). After the period of treatment with botulinum toxin alone has ended, the start of combined therapy is delayed until the effects on the MAS score for spasticity and the range of motion for abduction disappear, as judged subjectively by the patient or caregiver, before the next treatment. During the period of combined therapy, treatment with the diffused pressure wave is performed seven times at a frequency of once every two weeks, starting on the day of the botulinum toxin treatment. |
Outcome(s)
Primary Outcome | The modified Ashworth Scale (MAS) for both adductor muscles is the primary endpoint. The difference in MAS between baseline and 12 weeks after treatment with botulinum toxin alone will be compared with the difference in MAS between baseline and 12 weeks after treatment with botulinum toxin and radial pressure wave. |
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Secondary Outcome | Efficacy evaluation items The patient's improvement in movement will be evaluated based on the MAS of both adductor muscles and the course of MAS at each visit after treatment, the range of motion of the hip joint in passive abduction, the J-ZBI, which is a measure of the burden of care, symptoms, videos, etc., at each visit after treatment. In cases where the patient cannot be followed up, the final day of the last examination before the patient became unreachable will be used as the cutoff date. Safety Evaluation Items Adverse events during the observation period Definition: The proportion of study subjects who experienced adverse events among the number of study subjects excluding those who did not receive any study treatment among all registered patients. The severity (Grade) of the observed adverse events is the worst Grade of CTCAE v5.0 during the observation period. Percentage of complications Definition: Percentage of complications (fractures, muscle injuries, hematomas) occurring during the study period |
Key inclusion & exclusion criteria
Age minimum | >= 2age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients who meet all of the following criteria will be eligible for the study. (1) Patients aged 2 years or older. (2) Patients with spasticity of both adductor muscles due to cerebral palsy. (3) Patients who can provide written consent for participation in the study. If the patient is unable to provide consent due to mental retardation or other reasons, the consent of a substitute decision-maker will be obtained. (4) For patients who have already received botulinum toxin treatment, at least 12 weeks must have passed since the last botulinum administration at the time of consent. |
Exclude criteria | Patients who meet any of the following criteria will be excluded from the study. (1) Patients who have received intrathecal baclofen therapy. (2) Patients who are allergic to botulinum toxin. (3) Patients who have a tendency to bleed, as indicated by a recent examination. (4) Patients with a blood coagulation disorder (including local thrombosis). (5) Patients taking oral anticoagulants (6) Patients who have had the onset of the disease causing spasticity within the last 6 months (7) Patients who have had orthopedic spasticity suppression treatment for the hip within the last year (8) Patients who have participated in another interventional study within the last 4 months (9) Patients with systemic neuromuscular junction disorders (10) Pregnant women, women who may be pregnant, and breastfeeding women (11) Patients with a history of hypersensitivity to the ingredients of Botox (12) Patients who have received corticosteroid injections in the treatment area (13) Patients with tendon damage, tumors, or infections in the adductor muscles. (14) Patients who are judged to be unsuitable by the person in charge of this study. |
Related Information
Primary Sponsor | Harada Risa |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Wataru Saho |
Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Hyogo Japan 650-0017 |
Telephone | +81-78-382-6826 |
toby@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |
Scientific contact | |
Name | Risa Harada |
Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Hyogo Japan 650-0017 |
Telephone | +81-78-382-6826 |
risah@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |