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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02444351

Enrollment

Registered

2015-05-14

Start date

2015-06-26

Completion date

2016-06-30

Last updated

2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis With Nocturnal Calf Cramps

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).

Interventions

OTHERno intervention

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

DRUGbotulinum 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain score	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).

Secondary

Measure	Time frame	Description
patient satisfaction questionnaire using 0 to 4 scale	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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026