search
Back to results

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

Primary Purpose

Spinal Stenosis With Nocturnal Calf Cramps

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle
no intervention
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis With Nocturnal Calf Cramps

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

botox group

Arm Description

Outcomes

Primary Outcome Measures

Pain score
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

patient satisfaction questionnaire using 0 to 4 scale
assessment of patient satisfaction using 0 to 4 scale (0; very dissatisfied, 1; dissatisfied, 2; fair, 3; satisfied, 4; very satisfied)

Full Information

First Posted
April 28, 2015
Last Updated
January 9, 2019
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT02444351
Brief Title
Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 26, 2015 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis With Nocturnal Calf Cramps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Title
botox group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle
Intervention Description
ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
Patients in the control group will not receive any injection on the gastrocnemius muscle.
Primary Outcome Measure Information:
Title
Pain score
Description
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).
Time Frame
follow up 2 weeks (14 days) after injection
Secondary Outcome Measure Information:
Title
patient satisfaction questionnaire using 0 to 4 scale
Description
assessment of patient satisfaction using 0 to 4 scale (0; very dissatisfied, 1; dissatisfied, 2; fair, 3; satisfied, 4; very satisfied)
Time Frame
follow up 3 months after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28209505
Citation
Park SJ, Yoon KB, Yoon DM, Kim SH. Botulinum Toxin Treatment for Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):957-963. doi: 10.1016/j.apmr.2017.01.017. Epub 2017 Feb 14.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs