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Lumbar Spinal StenosisNCT04374669

Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

An observational study of Lumbar Spinal Stenosis and Neurogenic Claudication, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis. Read more about this study

Who is it for?
Ages 65 to 79 years
What is being tested?
Neuroplasty with Racz catheter
How many people
79 participants
Where
1 siteSouth Korea
Study dates
20 May 2020to 30 Apr 2023
How long will I take part?
6 Months
Phase
Observational
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 65 to 79 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients with lumbar spinal stenosis who is scheduled for neuroplasty in Asan medical center in Korea

Who may be able to join

  • Presence of lumbar spinal stenosis on MRI
  • 65 ≤ age <79
  • Neurogenic claudication due to spinal stenosis
  • Chronic pain above than 3 months despite conservative therapies
  • Scheduled for neuroplasty with Racz catheter

Who cannot join

  • Allergy to local anesthetics, contrast dye, or steroid
  • Use of anticoagulants or antiplatelet medication
  • Coagulopathy or Infection at the insertion site
  • Neurological or psychiatric disorders
  • Hemodynamic instability due to other underlying disorders
  • Prior spine instrumentation
  • Vascular claudication
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan medical center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: The Influence of Sarcopenia on Outcomes of Neuroplasty in Patients With Lumbar Spinal Stenosis: a Prospective Observational Study

The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.

Read the detailed description

Frailty is an aging-related syndrome of physiological decline and correlated with sarcopenia. Furthermore, lumbar spinal stenosis is a common disease in the old population and a neuroplasty is widely used to treat these patients. We postulate that the sarcopenia may be associated with the outcome of neuroplasty in patients with lumbar spinal stenosis, and there is no study about this topic as far as we know.

To evaluate this association, we will use the criteria for sarcopenia which is made by Asian Working Group for Sarcopenia in 2019 in this study. We will compare the outcome of neuroplasty in patients with sarcopenia and without sarcopenia using several tools such as numeric rating scale (NRS), Oswestry Disability Index (ODI), and global perceived effect (GPE) score up to 6 months after the procedure.

Being tested
Neuroplasty with Racz catheter
Keywords
Sarcopenia, Frailty, Lumbar spinal stenosis, Neurogenic claudication, Neuroplasty
Medical subject headings
Spinal Stenosis, Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuroplasty with Racz catheterProcedure or surgery

    The patient is placed in the prone position with a pillow placed under the abdomen to correct the lumbar lordosis. After sterile preparation and draping, the epidural space via the sacral hiatus using a 16 gauge needle is accessed. Then, the Racz catheter is advanced to the site of adhesions under the fluoroscopic guidance. The target site is determined by the location of pathology on lumbar MRI, preprocedural epidurography, and clinical symptoms before the adhesiolysis. Adhesiolysis is performed through the high-volume administration of medications, which consist of a combination of a steroid, local anesthetics, hyaluronidase, and 5% hypertonic saline. As needed, the catheter remains in the epidural space for two days, with the additional injection on each of the days.

Study groups in NCT04374669
Study groupRoleWhat they receive
patients with lumbar spinal stenosisPatients with lumbar spinal stenosis will be scheduled for neuroplasty.
Receives: Procedure: Neuroplasty with Racz catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in numeric rating scale (NRS) at 3 months after the procedure

    Numeric rating scale (0-10) 0=no pain, 10=worst pain imaginable

    We are going to compare the change of NRS at 3 months after the procedure to the baseline value.

    Measured: Before the procedure and 3 months after the procedure

  2. Change in Oswestry disability index (ODI) at 3 months after the procedure

    Oswestry disability index (10-60) 10: least score as possible, 60: most score as possible

    We are going to compare the change of ODI at 3 months after the procedure to the baseline value.

    Measured: Before the procedure and 3 months after the procedure

  3. Global percieved effect (GPE) score at 3 months after the procedure

    Global percieved effect score by Likert scale (1-7)

    1: Never satisfied with the procedure, 7: Very satisfied with the procedure

    Measured: 3 months after the procedure

  4. Change in Medication Quantification scale (MQS) at 3 months after the procedure

    Medication quantification scale is a tool to quantify medication regimen use in chronic pain populations. We are going to use Medication Quantification scale ver 3.

    The score starts at 0, and there is no specific maximum limit.

    We are going to compare the change of MQS at 3 months after the procedure to the baseline value.

    Measured: Before the procedure and 3 months after the procedure

  5. The percentage of successful responders at 3 months after the procedure

    We are going to assess 4 variables above and then decide who is a successful responder or not at 3 months after the procedure.

    We defined the successful responders as follows;

    1. ≥ 50% or 4-point reduction from baseline leg Numeric rating scale and no increase from baseline Oswestry disability index and medication quantification scale and 4 points on the global perceived scale,
    2. ≥ 30% or 2 points reduction from baseline numeric rating scale with any one of the following criteria: simultaneous ≥ 30% (or 10-point) reduction in Oswestry disability index from baseline, or ≥ 5 points on global perceived effects scale, or no increase from the baseline medication quantification scale.

    NRS, ODI, and MQS will be evaluated before the procedure and become baseline values.

    NRS, ODI, and MQS will be re-evaluated, and GPE score will be newly evaluated 3 months after the procedure.

    Measured: 3 months after the procedure

Secondary outcomes (5)

  1. Change in NRS at 1 and 6 months after the procedure

    We are going to compare the change of NRS at 1 and 6 months after the procedure to the baseline value.

    Measured: Before the procedure, and 1 and 6 months after the procedure

  2. Change in ODI at 1 and 6 months after the procedure

    We are going to compare the change of ODI at 1 and 6 months after the procedure to the baseline value.

    Measured: Before the procedure, and 1 and 6 months after the procedure

  3. GPE score at 1 and 6 months after the procedure

    We are going to check GPE score at 1 and 6 months after the procedure.

    Measured: 1 and 6 months after the procedure

  4. Change in MQS at 1 and 6 months after the procedure

    We are going to compare the change of MQS at 1 and 6 months after the procedure to the baseline value.

    Measured: Before the procedure, and 1 and 6 months after the procedure

  5. The percentage of successful responders at 1 and 6 months after the procedure

    We are going to evaluate successful responders at 1 and 6 months after the procedure

    Measured: 1 and 6 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start20 May 2020
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
79 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04374669
Sponsor's protocol ID
S2020-0855-0001
Status last verified
Dec 2022
First submitted
24 Apr 2020
Last updated
27 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bentov I, Kaplan SJ, Pham TN, Reed MJ. Frailty assessment: from clinical to radiological tools. Br J Anaesth. 2019 Jul;123(1):37-50. doi: 10.1016/j.bja.2019.03.034. Epub 2019 May 3.

    PubMed 31056240

  • Racz G, Candido K, Helm S. Neuroplasty Is a Safe, Effective Procedure. Anesth Analg. 2018 Jan;126(1):363. doi: 10.1213/ANE.0000000000002546. No abstract available.

    PubMed 29135599

  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

    PubMed 32033882

  • Yamada Y, Nishizawa M, Uchiyama T, Kasahara Y, Shindo M, Miyachi M, Tanaka S. Developing and Validating an Age-Independent Equation Using Multi-Frequency Bioelectrical Impedance Analysis for Estimation of Appendicular Skeletal Muscle Mass and Establishing a Cutoff for Sarcopenia. Int J Environ Res Public Health. 2017 Jul 19;14(7):809. doi: 10.3390/ijerph14070809.

    PubMed 28753945

  • Choi SS, Lee JH, Kim D, Kim HK, Lee S, Song KJ, Park JK, Shim JH. Effectiveness and Factors Associated with Epidural Decompression and Adhesiolysis Using a Balloon-Inflatable Catheter in Chronic Lumbar Spinal Stenosis: 1-Year Follow-Up. Pain Med. 2016 Mar;17(3):476-487. doi: 10.1093/pm/pnv018. Epub 2015 Dec 7.

    PubMed 26814254

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spinal Stenosis and Neurogenic Claudication, run by Asan Medical Center 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Dec 2022. 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?

Results are not available in the source record.

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?

Change in numeric rating scale (NRS) at 3 months after the procedure (time frame: Before the procedure and 3 months after the procedure). The study lists 5 primary outcomes in all. 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 NCT04374669, which also lists 5 linked publications.

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 27 Dec 2022.

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