Spinal Stenosis With Nocturnal Calf CrampsNCT02444351
Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
A study testing botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle in people with 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 botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spinal Stenosis With Nocturnal Calf Cramps
- What is being tested?
- botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jun 2015to 30 Jun 2016
- 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 20 to 80 years
- 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
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
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 botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability, patient satisfaction, and neurophysiological variables change using electrical stimulator between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).
- Being tested
- botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle, no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin type A (Nabota®) injection into the gastrocnemius muscleDrug
ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).
no interventionOther
Patients in the control group will not receive any injection on the gastrocnemius muscle.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Other: no intervention |
| botox group | Experimental | Not described Receives: Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle |
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 botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).
Measured: follow up 2 weeks (14 days) after injection
Secondary outcomes (1)
patient satisfaction questionnaire using 0 to 4 scale
assessment of patient satisfaction using 0 to 4 scale (0; very dissatisfied, 1; dissatisfied, 2; fair, 3; satisfied, 4; very satisfied)
Measured: follow up 3 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start26 Jun 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
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 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444351
- Sponsor's protocol ID
- 4-2015-0169
- Status last verified
- Jan 2017
- First submitted
- 28 Apr 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Park SJ, Yoon KB, Yoon DM, Kim SH. Botulinum Toxin Treatment for Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):957-963. doi: 10.1016/j.apmr.2017.01.017. Epub 2017 Feb 14.
PubMed 28209505
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT02444351
- Acronym / sponsor ID
- 4-2015-0169
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 14 May 2015 (estimated)
- 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 botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability, patient satisfaction, and neurophysiological variables change using electrical stimulator between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).
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 | Other: no intervention |
| botox group | Experimental | Drug: botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle |
Who may qualify
- Ages
- 20 to 80 years
- 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 |
|---|---|---|
| botulinum toxin type A (Nabota®) injection into the gastrocnemius muscleultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf). | Drug | botox group |
| no interventionPatients in the control group will not receive any injection on the gastrocnemius muscle. | Other | control group |
Primary outcome
Pain score
Time frame: follow up 2 weeks (14 days) after injection
A comparison of pain score between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).
1 secondary outcome
patient satisfaction questionnaire using 0 to 4 scale
Time frame: follow up 3 months after injection
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 11 Jan 2019.
- Derived from this study: PubMed 28209505Park SJ, Yoon KB, Yoon DM, Kim SH. Botulinum Toxin Treatment for Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):957-963. doi: 10.1016/j.apmr.2017.01.017. Epub 2017 Feb 14.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle in people with 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 11 Jan 2019. 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 2 weeks (14 days) after injection). 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 NCT02444351, 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 11 Jan 2019.