Efficacy of Extracorporeal Shock Wave Therapy on Spasticity
- Conditions
- StrokeSpasticity, Muscle
- Interventions
- Drug: BoNT ADevice: ESWT
- Registration Number
- NCT06225024
- Lead Sponsor
- Kayseri City Hospital
- Brief Summary
Introduction: We aimed to compare the efficacy of Botulinum Toxin Type A(BoNT-A) injection and BoNT-A injection in combination with ESWT for post-stroke lower extremity ankle plantar flexor spasticity.
Materials and Method: Patients with post-stroke ankle plantar flexor spasticity of 1 or more on the modified Ashworth Scale(MAS) were randomized into two groups.
Group 1(n:20): BoNT-A was injected into the gastrocnemius muscle and conventional physical therapy exercises were performed.
Group 2(n:20): ESWT was applied to the gastrocnemius muscle in addition to the treatments in group 1.
- Detailed Description
Group 1 (n:20): BoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks.
Group 2 (n:20): In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.
The patients in both groups underwent the following evaluations before treatment, at one month and three months after treatment by a treatment-blinded Physical Medicine and Rehabilitation (PMR) physician.
Patients' age, sex, occupation, hemiplegic sides, and etiology of hemiplegia were recorded. Physical examination was performed, and examination findings were recorded. The presence of post-treatment pain, redness, tenderness, or other adverse findings were questioned.
MAS, Brunnstrom Motor Recovery Stage(BMRS), ankle range of motion(ROM) measurement, clonus score(CS), Barthel Index(BI), Heckmatt measurements with ultrasonography, and visual analog scale(VAS) evaluations were performed on the patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BoNT-A BoNT A BoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks. BoNT-A and ESWT ESWT In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle. BoNT-A and ESWT BoNT A In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle.
- Primary Outcome Measures
Name Time Method Modified Ashworth Scale (MAS) at baseline, at one month and three months after treatment This scale is used to evaluate the severity of spasticity. MAS is based on a subjective evaluation of the resistance felt during the examination.
0: No tone increase
1. Slight increase in tone characterized by a catch and release or minimal resistance at the end of the range of motion 1+: Slight increase in muscle tone with minimal resistance throughout less than half of the range of motion
2. Increased muscle tone throughout the entire range of motion, but joints can be easily moved
3. Considerable increase in tone; passive movement is difficult
4. Affected parts are rigid in flexion and extension.
- Secondary Outcome Measures
Name Time Method Brunnstrom Motor Recovery Stage (BMRS) at baseline, at one month and three months after treatment It is a motor function assessment scale to evaluate the motor development of hemiplegic patients. According to Brunnstrom, there are six stages in the recovery process of hemiplegic patients, and the upper extremity, lower extremity, and hands are individually evaluated. A higher BMRS indicates better motor development
Trial Locations
- Locations (1)
Health Sciences University, Kayseri Medicine Faculty
🇹🇷Kayseri, Kocasinan, Turkey