Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator |
| |
| botox group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle | Drug | ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28209505 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| no intervention | Other | Patients in the control group will not receive any injection on the gastrocnemius muscle. |
|
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided