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

January 9, 2019 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Other: no intervention
Patients in the control group will not receive any injection on the gastrocnemius muscle.
Experimental: botox group
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
follow up 2 weeks (14 days) after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction questionnaire using 0 to 4 scale
Time Frame: 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)
follow up 3 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2015

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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