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

NCT05392361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-30

No results posted yet for this study

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).

Conditions

  • Lumbar Spinal Stenosis With Nocturnal Calf Cramps

Interventions

DRUG

gabapentin (neurontin® capsule 300mg) treatment

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

DRUG

baclofen (baclofen Tab. 10mg) treatment

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Shin Hyung Kim · Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2023-03-24
Completion
2023-03-24

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392361 on ClinicalTrials.gov