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

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis With Nocturnal Calf Cramps
• Interventions: Drug: gabapentin (neurontin® capsule 300mg) treatment; Drug: baclofen (baclofen Tab. 10mg) treatment

• Registration Number: NCT05392361
• Lead Sponsor: Yonsei University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-26
• Study Start: 2022-06-09
• Status Verified: 2023-03
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	gabapentin (neurontin® capsule 300mg) treatment	conservative management for spinal stenosis
baclofen group	baclofen (baclofen Tab. 10mg) treatment	conservative management for spinal stenosis plus baclofen treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
Insomnia severity index	follow up 4 weeks, 12 weeks
Oswestry Disability Index	follow up 4 weeks, 12 weeks

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of