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A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Limaprost Tablets for Patients with Residual Paresthesia after Lumbar Fusion Surgery for Degenerative Lumbar Spinal Stenosis

A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Limaprost Tablets for Patients with Residual Paresthesia after Lumbar Fusion Surgery for Degenerative Lumbar Spinal Stenosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092866
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-11-25
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative residual neurological symptoms of degenerative lumbar spinal stenosis

Interventions

limaprost tablet group:Take limaprost tablets, 3 times a day, 5 µg/time
Celecoxib group:Take celecoxib capsules, once daily, 0.2 g/time

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his/her guardian voluntarily participates in the study and signs informed consent, and can comply with the programme and the procedures of visits; 2. In our hospital for degenerative lumbar spinal stenosis in patients with single-level lumbar fusion surgery, patients discharged from the day (D10) to assess their postoperative residual pain; Or in the outside hospital because of degenerative lumbar spinal stenosis single-level lumbar fusion surgery, postoperative residual pain to our hospital outpatient clinic patients

Exclusion criteria

Exclusion criteria: 1. The patient is pregnant or lactating 2. Participants who had participated in other drug trials within 30 days of enrollment 3. The researchers considered that participants were not suitable to participate in the trial

Design outcomes

Primary

MeasureTime frame
The improvement rate of VAS score after 3-month treatment;

Secondary

MeasureTime frame
The improvement rate of numbness after 3-month treatment;Improvement rate of ODI at last follow-up;Improvement rate of EQ-5D at last follow-up;Improvement rate of Hamilton depression scale scores and Hamilton Anxiety Rating Scale scores;Time to return to work/life during follow-up;Incidence of adverse events during various treatment periods;

Countries

China

Contacts

Public ContactQingchu Li

The Third Affiliated Hospital of Southern Medical University

lqc16@263.net+86 186 8022 5370

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026