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

Spinal Stenosis With Nocturnal Calf Cramps Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444351
• Other study ID #: 4-2015-0169
• Status: Completed
• Phase: N/A
• Start date: June 26, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis With Nocturnal Calf Cramps

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	follow up 3 months after injection