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

Not Applicable

Completed

• Conditions: Spinal Stenosis With Nocturnal Calf Cramps
• Interventions: Other: no intervention; Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle

• Registration Number: NCT02444351
• Lead Sponsor: Yonsei University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Study Start: 2015-06-26
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	no intervention	-
botox group	botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle	-

Primary Outcome Measures

Name	Time	Method
Pain score	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 Outcome Measures

Name	Time	Method
patient satisfaction questionnaire using 0 to 4 scale	follow up 3 months after injection	assessment of patient satisfaction using 0 to 4 scale (0; very dissatisfied, 1; dissatisfied, 2; fair, 3; satisfied, 4; very satisfied)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of