|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02444351 |
|
Date of registration:
|
28/04/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
June 26, 2015 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02444351 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Spinal Stenosis With Nocturnal Calf Cramps
|
|
Intervention(s)
|
|
Other: no intervention
|
|
Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle
|
|
Primary Outcome(s)
|
|
Pain score
[Time Frame: follow up 2 weeks (14 days) after injection]
|
|
Secondary Outcome(s)
|
|
patient satisfaction questionnaire using 0 to 4 scale
[Time Frame: follow up 3 months after injection]
|
|
Secondary ID(s)
|
|
4-2015-0169
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|