Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial

Conditions
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Lumbar Spinal Stenosis With Nocturnal Calf Cramps

Intervention / Treatment
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* Drug: gabapentin (neurontin® capsule 300mg) treatment
* Drug: baclofen (baclofen Tab. 10mg) treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed lumbar spinal stenosis with MRI finding nocturnal calf cramps symptoms at least once per week Exclusion Criteria: electrolyte disorder congenital muscle disease muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.) cognitive impairments

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>conservative management for spinal stenosis | Drug: gabapentin (neurontin® capsule 300mg) treatment<br>* Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment<br>|
| Experimental: baclofen group<br>conservative management for spinal stenosis plus baclofen treatment | Drug: baclofen (baclofen Tab. 10mg) treatment<br>* Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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baclofen, spinal stenosis, nocturnal calf cramps