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

Yonsei University40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lumbar Spinal Stenosis With Nocturnal Calf Cramps

Interventions

gabapentin (neurontin® capsule 300mg) treatmentDRUG

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

baclofen (baclofen Tab. 10mg) treatmentDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Pain score

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".

Time frame: follow up 4 weeks

Secondary Outcomes

Frequency and severity of nocturnal calf cramps

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)

Time frame: follow up 4 weeks, 12 weeks

Insomnia severity index

Time frame: follow up 4 weeks, 12 weeks

Oswestry Disability Index

Time frame: follow up 4 weeks, 12 weeks

Patient satisfaction (PGIC)

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)

Time frame: follow up 4 weeks, 12 weeks

Data from ClinicalTrials.gov

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