NCT07855445

Brief Summary

This cross-sectional observational study aims to evaluate neuropathic pain severity in patients with lumbar spinal stenosis (LSS) and to investigate its association with radiological findings. Neuropathic pain will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Pain intensity, neuropathic pain characteristics, functional status, walking capacity, and psychological symptoms will also be assessed. The relationships between NPSI scores and clinical, functional, psychological, and radiological parameters will be investigated.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Oct 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

September 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

Neuropathic painSpinal stenosis

Outcome Measures

Primary Outcomes (1)

  • Neuropathic Pain Symptom Inventory Total Intensity Score

    Neuropathic pain symptom intensity will be assessed using the Neuropathic Pain Symptom Inventory (NPSI). The total intensity score is calculated as the sum of 10 symptom descriptor scores and ranges from 0 to 100, with higher scores indicating greater neuropathic pain symptom intensity.

    Single assessment at baseline

Secondary Outcomes (3)

  • Association Between Neuropathic Pain Severity and Radiological Severity

    Single assessment at baseline

  • Association Between Neuropathic Pain Severity and Clinical Pain Intensity

    Single assessment at baseline

  • Association Between Neuropathic Pain Severity and Functional Status

    Single assessment at baseline

Study Arms (1)

Patients with Lumbar Spinal Stenosis

Patients diagnosed with lumbar spinal stenosis based on clinical and magnetic resonance imaging (MRI) findings. Participants will undergo a single cross-sectional assessment including neuropathic pain symptoms, pain intensity, functional status, walking capacity, psychological symptoms, and radiological severity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with clinically and radiologically confirmed lumbar spinal stenosis who present with low back and/or leg pain or symptoms of neurogenic claudication.

You may qualify if:

  • Age ≥18 years.
  • Diagnosis of lumbar spinal stenosis based on clinical evaluation and lumbar magnetic resonance imaging findings.
  • Presence of low back and/or leg pain or symptoms of neurogenic claudication.
  • Sufficient cognitive ability to understand and complete the study questionnaires.

You may not qualify if:

  • Presence of diabetic neuropathy, polyneuropathy, peripheral nerve entrapment neuropathy, or other causes of neuropathic pain.
  • Acute symptomatic lumbar disc herniation considered to be the primary cause of radicular symptoms.
  • Active malignancy or a history of spinal metastasis.
  • History of major lumbar spine surgery, such as lumbar fusion.
  • Severe psychiatric disorder or cognitive impairment that prevents reliable completion of the study questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeuralgiaSpinal Stenosis

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Nurbanu Hindioglu Dogan

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.

Locations