Menu
Recruiting NCT07488936

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

Observational Failed Back Surgery Syndrome Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Failed Back Surgery Syndrome, Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • Effect of pain types on quality of life in patients with failed back surgery syndrome [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Konya Beyhekim Eğitim Araştırma Hastanesi — Konya

Publications

  • Manchikanti L, Singh V. Failed back surgery: etiology and diagnostic evaluation. Spine J. 2004 Jul-Aug;4(4):486-8; author reply 488-9. doi: 10.1016/j.spinee.2004.03.007. No abstract available. PMID 15246312

Identifiers

NCT: NCT07488936 · KonyaBeyhekimTRH2023/360

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗