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

March 29, 2023 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
conservative management for spinal stenosis
Drug: gabapentin (neurontin® capsule 300mg) treatment
Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment
Experimental: baclofen group
conservative management for spinal stenosis plus baclofen treatment
Drug: baclofen (baclofen Tab. 10mg) treatment
Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 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".
follow up 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and severity of nocturnal calf cramps
Time Frame: 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)
follow up 4 weeks, 12 weeks
Insomnia severity index
Time Frame: follow up 4 weeks, 12 weeks
follow up 4 weeks, 12 weeks
Oswestry Disability Index
Time Frame: follow up 4 weeks, 12 weeks
follow up 4 weeks, 12 weeks
Patient satisfaction (PGIC)
Time Frame: 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)
follow up 4 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Shin Hyung Kim, Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Actual)

March 24, 2023

Study Completion (Actual)

March 24, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-0360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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