Lumbar Spinal Stenosis With Nocturnal Calf Cramps
Conditions
Keywords
baclofen, spinal stenosis, 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 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).
Interventions
DRUGgabapentin (neurontin® capsule 300mg) treatment
Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment
DRUGbaclofen (baclofen Tab. 10mg) treatment
Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of nocturnal calf cramps | follow up 4 weeks, 12 weeks | 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) |
| Insomnia severity index | follow up 4 weeks, 12 weeks | — |
| Oswestry Disability Index | follow up 4 weeks, 12 weeks | — |
| Patient satisfaction (PGIC) | follow up 4 weeks, 12 weeks | 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) |
Countries
South Korea
Outcome results
None listed