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Clinical trial

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

ID
Name
4-2022-0360
Description
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).
Trial arms
Trial start
2022-06-09
Estimated PCD
2023-03-24
Trial end
2023-03-24
Status
Completed
Treatment
gabapentin (neurontin® capsule 300mg) treatment
Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment
Arms:
control group
baclofen (baclofen Tab. 10mg) treatment
Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.
Arms:
baclofen group
Size
40
Primary endpoint
Pain score
follow up 4 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-03-30

1 organization

2 products

1 indication

Organization
Yonsei University
Product
Gabapentin
Indication
Lumbar Spinal Stenosis
Product
Baclofen