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Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of baclofen in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability and patient satisfaction between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | conservative management for spinal stenosis |
|
| baclofen group | Experimental | conservative management for spinal stenosis plus baclofen treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gabapentin (neurontin® capsule 300mg) treatment | Drug | Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | A comparison of pain score between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment). The pain score will be measured using NRS (Numeric Rating Scale) on a scale from 0-10, with 0 representing "no pain" and 10 "worst possible pain". | follow up 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of nocturnal calf cramps | The frequency(number) and the severity of nocturnal calf cramps that occurred in a week before each time frame will be investigated. The severity of nocturnal calf cramps will be measured by 0-4 point scale (0, no pain; 1, mild pain that disappeared immediately and tolerable; 2, moderate pain accompanied by pain enough to wake up from sleep; 3, severe pain accompanied by pain enough to wake up from sleep for a long time; 4, severe pain that lasted for a long time and affected a daily life of the next day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shin Hyung Kim | Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38063320 | Derived | Kim HJ, Yoon KB, Kang M, Lee HW, Kim SH. Use of Baclofen as a Treatment for Nocturnal Calf Cramps in Individuals With Lumbar Spinal Stenosis: A Prospective Randomized Study. Am J Phys Med Rehabil. 2024 May 1;103(5):384-389. doi: 10.1097/PHM.0000000000002364. Epub 2023 Nov 22. |
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| baclofen (baclofen Tab. 10mg) treatment | Drug | Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night. |
|
| follow up 4 weeks, 12 weeks |
| Insomnia severity index | follow up 4 weeks, 12 weeks |
| Oswestry Disability Index | follow up 4 weeks, 12 weeks |
| Patient satisfaction (PGIC) | Patient satisfaction with treatment at 12 weeks after treatment will be measured by 7-point Patient Global Impression of Change (PGIC; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse) | follow up 4 weeks, 12 weeks |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D013812 | Therapeutics |
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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