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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-03-24

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).

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Detailed Description

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Conditions

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Lumbar Spinal Stenosis With Nocturnal Calf Cramps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

conservative management for spinal stenosis

Group Type ACTIVE_COMPARATOR

gabapentin (neurontin® capsule 300mg) treatment

Intervention Type DRUG

Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment

baclofen group

conservative management for spinal stenosis plus baclofen treatment

Group Type EXPERIMENTAL

baclofen (baclofen Tab. 10mg) treatment

Intervention Type DRUG

Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.

Interventions

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gabapentin (neurontin® capsule 300mg) treatment

Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment

Intervention Type DRUG

baclofen (baclofen Tab. 10mg) treatment

Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No