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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07488936
Acronym
back pain
Enrollment
200
Registered
2026-03-23
Start date
2025-12-01
Completion date
2026-12-01
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Failed Back Surgery Syndrome

Keywords

failed back surgery syndrome, back pain, types of pain

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.

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.

Interventions

None listed

Sponsors

Konya Beyhekim Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of pain types on quality of life in patients with failed back surgery syndromeBaselineQuality 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTemrah çetin, doctor
dremrahcetin4547@gmail.com+905417606950
CONTACTSAVAŞ KARPUZ, AASSOCIATE PROFESSOR DOCTOR
svskrpz@hotmail.com+905552057860
STUDY_DIRECTORsavaş KARPUZ, ASSOCIATE PROFESSOR DOCTOR

KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ

STUDY_DIRECTORSAVAŞ KARPUZ

KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026