Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 14, 2015
CompletedStudy Start
First participant enrolled
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedJanuary 11, 2019
January 1, 2017
1 year
April 28, 2015
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
follow up 2 weeks (14 days) after injection
Secondary Outcomes (1)
patient satisfaction questionnaire using 0 to 4 scale
follow up 3 months after injection
Study Arms (2)
control group
ACTIVE COMPARATORbotox group
EXPERIMENTALInterventions
ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).
Patients in the control group will not receive any injection on the gastrocnemius muscle.
Eligibility Criteria
You may qualify if:
- diagnosed lumbar spinal stenosis with MRI finding
- nocturnal calf cramps symptoms at least once per week
You may not qualify if:
- electrolyte disorder
- congenital muscle disease
- muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
- cognitive impairments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 28209505DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 14, 2015
Study Start
June 26, 2015
Primary Completion
June 30, 2016
Study Completion
June 30, 2016
Last Updated
January 11, 2019
Record last verified: 2017-01