Konya Beyhekim Eğitim Araştırma Hastanesi
Konya, Selçuklu, 42060, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07488936
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Konya, Selçuklu, 42060, Turkey (Türkiye)
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Contact information is provided by the study sponsor or research team.
SAVAŞ KARPUZ, AASSOCIATE PROFESSOR DOCTOR
CONTACT
emrah çetin, doctor
CONTACT
Konya Beyhekim Training and Research Hospital
Other Gov
Acronym: back pain
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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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