Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis

Yonsei University

Status: Completed

Conditions: Spinal Stenosis With Nocturnal Calf Cramps

Treatments: Other: no intervention; Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle

Study type: Interventional

Funder types: Other

Identifiers

NCT02444351

4-2015-0169

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed lumbar spinal stenosis with MRI finding
2. nocturnal calf cramps symptoms at least once per week

Exclusion criteria

1. electrolyte disorder
2. congenital muscle disease
3. muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
4. cognitive impairments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

control group

Active Comparator group

Treatment:

Other: no intervention

botox group

Experimental group

Treatment:

Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle