NCT07488936

Brief Summary

The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome. The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months. Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment. To determine the type of pain: Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain. For nociplastic pain affecting the musculoskeletal system, a diagnosis of nociplastic pain will be made according to clinical criteria and grading scores. Those who do not meet these criteria will be classified as having nociceptive pain.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 23, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

December 12, 2025

Last Update Submit

March 18, 2026

Conditions

Keywords

failed back surgery syndromeback paintypes of pain

Outcome Measures

Primary Outcomes (1)

  • Effect of pain types on quality of life in patients with failed back surgery syndrome

    Quality of life will be assessed using the SF-36 , Pain Catastrophizing Scale-PCS , The Roland-Morris Disability Questionnaire-RMDQ, DN4 (Douleur Neuropathique 4 Questions) Vizüel Analog Scale (VAS) scale and quality of life scores will be compared according to different pain types.

    Baseline

Eligibility Criteria

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

The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.

You may qualify if:

  • \*Being over 18 years of age
  • Being willing to participate in the study
  • Having been diagnosed with failed back surgery syndrome

You may not qualify if:

  • \*Those under 18 years of age
  • Those with major psychiatric illnesses
  • Those with communication problems
  • Other causes of back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Eğitim Araştırma Hastanesi

Konya, Selçuklu, 42060, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Manchikanti L, Singh V. Failedbacksurgery: etiology and diagnosticevaluation. Spine J. 2004;4(4):486-8.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Failed Back Surgery SyndromeChronic PainBack Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • savaş KARPUZ, ASSOCIATE PROFESSOR DOCTOR

    KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ

    STUDY DIRECTOR
  • SAVAŞ KARPUZ

    KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ

    STUDY DIRECTOR

Central Study Contacts

emrah çetin, doctor

CONTACT

SAVAŞ KARPUZ, AASSOCIATE PROFESSOR DOCTOR

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

March 23, 2026

Study Start

December 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

failed spinal surgeon syndrome

Locations