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

Yonsei University

Status: Completed

Conditions: Lumbar Spinal Stenosis With Nocturnal Calf Cramps

Treatments: Drug: gabapentin (neurontin® capsule 300mg) treatment; Drug: baclofen (baclofen Tab. 10mg) treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05392361

4-2022-0360

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

control group

Active Comparator group

Description:

conservative management for spinal stenosis

Treatment:

Drug: gabapentin (neurontin® capsule 300mg) treatment

baclofen group

Experimental group

Description:

conservative management for spinal stenosis plus baclofen treatment

Treatment:

Drug: baclofen (baclofen Tab. 10mg) treatment