Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain score
Study Overview
Brief Summary
Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability, patient satisfaction, and neurophysiological variables change using electrical stimulator between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed lumbar spinal stenosis with MRI finding
- •nocturnal calf cramps symptoms at least once per week
Exclusion Criteria
- •electrolyte disorder
- •congenital muscle disease
- •muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
- •cognitive impairments
Arms & Interventions
control group
Intervention: no intervention (Other)
botox group
Intervention: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle (Drug)
Outcomes
Primary Outcomes
Pain score
Time Frame: follow up 2 weeks (14 days) after injection
A comparison of pain score between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).
Secondary Outcomes
- patient satisfaction questionnaire using 0 to 4 scale(follow up 3 months after injection)