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NCT Number: NCT07488936

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Beyhekim Eğitim Araştırma Hastanesi

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location status: Recruiting

Location contact

Emrah Çetin, doctor

CONTACT

[email protected]

05417606950

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

SAVAŞ KARPUZ, AASSOCIATE PROFESSOR DOCTOR

CONTACT

[email protected]

+905552057860

emrah çetin, doctor

CONTACT

[email protected]

+905417606950

Sponsors and collaborators

Lead sponsor

Konya Beyhekim Training and Research Hospital

Other Gov

Registry information

Acronym: back pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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