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

Primary Purpose

Lumbar Spinal Stenosis With Nocturnal Calf Cramps

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gabapentin (neurontin® capsule 300mg) treatment
baclofen (baclofen Tab. 10mg) treatment
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis With Nocturnal Calf Cramps focused on measuring baclofen, spinal stenosis, nocturnal calf cramps

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

baclofen group

Arm Description

conservative management for spinal stenosis

conservative management for spinal stenosis plus baclofen treatment

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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)
Insomnia severity index
Oswestry Disability Index
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)

Full Information

First Posted
May 18, 2022
Last Updated
March 29, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05392361
Brief Title
Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
Official Title
Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis With Nocturnal Calf Cramps
Keywords
baclofen, spinal stenosis, nocturnal calf cramps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
conservative management for spinal stenosis
Arm Title
baclofen group
Arm Type
Experimental
Arm Description
conservative management for spinal stenosis plus baclofen treatment
Intervention Type
Drug
Intervention Name(s)
gabapentin (neurontin® capsule 300mg) treatment
Intervention Description
Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment
Intervention Type
Drug
Intervention Name(s)
baclofen (baclofen Tab. 10mg) treatment
Intervention Description
Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.
Primary Outcome Measure Information:
Title
Pain score
Description
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 Outcome Measure Information:
Title
Frequency and severity of nocturnal calf cramps
Description
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
Title
Insomnia severity index
Time Frame
follow up 4 weeks, 12 weeks
Title
Oswestry Disability Index
Time Frame
follow up 4 weeks, 12 weeks
Title
Patient satisfaction (PGIC)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed lumbar spinal stenosis with MRI finding nocturnal calf cramps symptoms at least once per week Exclusion Criteria: electrolyte disorder congenital muscle disease muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.) cognitive impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin Hyung Kim
Organizational Affiliation
Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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