Lumbar Spinal Stenosis With Nocturnal Calf CrampsNCT05392361
Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
A study testing gabapentin (neurontin® capsule 300mg) treatment and baclofen (baclofen Tab. 10mg) treatment in people with Lumbar Spinal Stenosis With Nocturnal Calf Cramps, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis With Nocturnal Calf Cramps
- What is being tested?
- gabapentin (neurontin® capsule 300mg) treatment and baclofen (baclofen Tab. 10mg) treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2022to 24 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed lumbar spinal stenosis with MRI finding
- nocturnal calf cramps symptoms at least once per week
Who cannot join
- electrolyte disorder
- congenital muscle disease
- muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
- cognitive impairments
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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).
- Being tested
- gabapentin (neurontin® capsule 300mg) treatment, baclofen (baclofen Tab. 10mg) treatment
- Keywords
- baclofen, spinal stenosis, nocturnal calf cramps
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | conservative management for spinal stenosis Receives: Drug: gabapentin (neurontin® capsule 300mg) treatment |
| baclofen group | Experimental | conservative management for spinal stenosis plus baclofen treatment Receives: Drug: baclofen (baclofen Tab. 10mg) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: follow up 4 weeks
Secondary outcomes (4)
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)
Measured: follow up 4 weeks, 12 weeks
Insomnia severity index
Measured: follow up 4 weeks, 12 weeks
Oswestry Disability Index
Measured: 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)
Measured: follow up 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start9 Jun 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal Stenosis With Nocturnal Calf CrampsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shin Hyung Kim, Principal investigator, Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392361
- Sponsor's protocol ID
- 4-2022-0360
- Status last verified
- Mar 2023
- First submitted
- 18 May 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HJ, Yoon KB, Kang M, Lee HW, Kim SH. Use of Baclofen as a Treatment for Nocturnal Calf Cramps in Individuals With Lumbar Spinal Stenosis: A Prospective Randomized Study. Am J Phys Med Rehabil. 2024 May 1;103(5):384-389. doi: 10.1097/PHM.0000000000002364. Epub 2023 Nov 22.
PubMed 38063320
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05392361
- Acronym / sponsor ID
- 4-2022-0360
- Keywords
- baclofen, spinal stenosis, nocturnal calf cramps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: gabapentin (neurontin® capsule 300mg) treatmentconservative management for spinal stenosis |
| baclofen group | Experimental | Drug: baclofen (baclofen Tab. 10mg) treatmentconservative management for spinal stenosis plus baclofen treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed lumbar spinal stenosis with MRI finding
- nocturnal calf cramps symptoms at least once per week
Key exclusion criteria (4 listed)
- electrolyte disorder
- congenital muscle disease
- muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
- cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gabapentin (neurontin® capsule 300mg) treatmentTaking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment | Drug | control group |
| baclofen (baclofen Tab. 10mg) treatmentTaking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night. | Drug | baclofen group |
Primary outcome
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".
4 secondary outcomes
Frequency and severity of nocturnal calf cramps
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)
Time frame: follow up 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 38063320Kim HJ, Yoon KB, Kang M, Lee HW, Kim SH. Use of Baclofen as a Treatment for Nocturnal Calf Cramps in Individuals With Lumbar Spinal Stenosis: A Prospective Randomized Study. Am J Phys Med Rehabil. 2024 May 1;103(5):384-389. doi: 10.1097/PHM.0000000000002364. Epub 2023 Nov 22.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin Hyung Kim principal investigator
Anesthesiology and Pain Medicine, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gabapentin (neurontin® capsule 300mg) treatment and baclofen (baclofen Tab. 10mg) treatment in people with Lumbar Spinal Stenosis With Nocturnal Calf Cramps, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: follow up 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.