Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome (back pain)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Failed Back Surgery Syndrome

Detailed Description

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.

This study is designed as a prospective, hospital-based study. Twenty hundred patients with failed lumbar spine syndrome who presented to the physical therapy and rehabilitation (PHR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of low back pain lasting at least three months will be included in the study. A power analysis could not be performed due to the lack of similar studies in the literature review. Once 200 patients are reached, a PoSHOCK power analysis will be performed, and if an 80% power ratio is not achieved, patient recruitment will continue. Detailed histories and physical examinations will be conducted for all participants. Sociodemographic and clinical characteristics of the participants will be determined through questions regarding age, gender, height, weight, education level, employment status, and income level.

Inclusion Criteria *Being over 18 years of age

• Being willing to participate in the study
• Having been diagnosed with failed back surgery syndrome Exclusion Criteria
• Those under 18 years of age
• Those with major psychiatric illnesses
• Those with communication problems
• Other causes of back pain Once 200 patients are reached, a Poshoc power analysis will be performed, and if an 80% power ratio is not achieved, patient recruitment will continue.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: emrah çetin, doctor; Phone Number: +905417606950; Email: dremrahcetin4547@gmail.com
• Study Contact Backup: Name: SAVAŞ KARPUZ, AASSOCIATE PROFESSOR DOCTOR; Phone Number: +905552057860; Email: svskrpz@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Selçuklu
    • Konya, Selçuklu, Turkey (Türkiye), 42060
      • Recruiting
      • Konya Beyhekim Eğitim Araştırma Hastanesi
      • Contact: Emrah Çetin, doctor; Phone Number: 05417606950; Email: dremrahcetin4547@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• *Being over 18 years of age

  • Being willing to participate in the study
  • Having been diagnosed with failed back surgery syndrome

Exclusion Criteria:

• *Those under 18 years of age

  • Those with major psychiatric illnesses
  • Those with communication problems
  • Other causes of back pain

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Konya Beyhekim Training and Research Hospital
• Investigators: Study Director: savaş KARPUZ, ASSOCIATE PROFESSOR DOCTOR, KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ; Study Director: SAVAŞ KARPUZ, KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ

Publications and helpful links

General Publications

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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: back pain; failed back surgery syndrome; types of pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Chronic Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: KonyaBeyhekimTRH2023/360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: failed spinal surgeon syndrome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No