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

NCT02444351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-01-11

No results posted yet for this study

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).

Conditions

  • Spinal Stenosis With Nocturnal Calf Cramps

Interventions

DRUG

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

ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).

OTHER

no intervention

Patients in the control group will not receive any injection on the gastrocnemius muscle.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-26
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444351 on ClinicalTrials.gov