跳至主要内容
临床试验/NCT07163546
NCT07163546Enrolling By Invitation不适用

Investigation of the Outcomes of the Person-Centered Lifestyle Redesign in Individuals With Chronic Low Back Pain

Hacettepe University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
70
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

This study is designed to examine the effects of a person-centered lifestyle intervention on pain, occupational performance, quality of life, disability, physical activity levels, and mental status in individuals with chronic low back pain.

详细描述

Low back pain is the most common musculoskeletal disorder worldwide; 70-80% of the adult population experiences this condition at some point in their lives. It is considered a leading cause of workforce loss and years lived with functional disability, and it ranks among the top five most frequent diagnoses in primary healthcare. Chronic low back pain is a significant public health problem globally, associated with substantial discomfort, disability, medical costs, and economic burden.

Chronic low back pain can severely reduce quality of life and has a significant comorbidity with mental health; therefore, it not only restricts an individual's physical activities and daily tasks but also negatively impacts psychological well-being, leading to higher levels of subclinical depression and anxiety. Non-surgical treatment options for chronic low back pain include pharmacological and non-pharmacological therapies.

Within the pharmacological approach, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids are commonly prescribed. Despite their therapeutic efficacy, this approach has significant drawbacks. It provides limited improvement in pain and functional limitations for most patients, which is frustrating. Furthermore, the long-term use of NSAIDs and opioids can cause serious side effects such as gastrointestinal bleeding, arterial thrombosis, addiction, and mental dysfunction.

While non-pharmacological therapies individually have positive effects, there is a lack of conclusive evidence supporting the superiority of one approach over others. Consequently, the treatment process should be tailored to the needs of the individual with chronic low back pain, and it appears that combined therapies addressing the individual holistically are needed to achieve effective results. The biopsychosocial approach to treating chronic pain considers biological, psychological, and social factors. Clinical guidelines for chronic low back pain have shown a shift towards the biopsychosocial model. This can provide clinicians with some insights into additional areas to consider in their patients' treatment.

Lifestyle risk factors such as excess weight, physical inactivity, poor nutrition, and smoking play a role in the development of low back pain. Studies suggest that addressing such lifestyle factors can improve outcomes in low back pain, including disability. Despite evidence suggesting the potential benefits of interventions targeting these lifestyle factors, only one randomized controlled trial has been conducted for patients with chronic low back pain. This study found no effect, largely due to insufficient adherence to the treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being between 18-65 years old
  • •Lower back pain lasting ≥3 months
  • •Pain at least 4 according to VAS
  • •Being literate

排除标准

  • •Presence of congenital or acquired spinal deformity (scoliosis, kyphosis, spondylolisthesis),
  • •Presence of history of spinal surgery (<12 months) (spinal fusion, discectomy),
  • •Diagnosis of radiculopathy or neuropathy (spinal canal stenosis),
  • •Presence of serious fractures or pathologies (vertebral fractures, infections),
  • •Presence of malignancy,
  • •Presence of chronic cardiovascular and pulmonary diseases,
  • •Severe psychiatric, neurological, infectious, renal or inflammatory disorders,
  • •Systematic metabolic disorder,
  • •Pregnancy
  • •BMI ≥ 30 kg/m²

研究组 & 干预措施

Lifestyle intervention and Physical therapy

Experimental

It is a group that receives physical therapy and lifestyle intervention.

干预措施: Lifestyle intervention (Behavioral)

Physical therapy

No Intervention

This group only receives physical therapy

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: six months

The Visual Analog Scale (VAS) is a simple, effective, valid, and reliable tool that is internationally recognized for assessing participants' pain intensity. Participants are asked to mark on a 10 cm horizontal line to indicate how severely they perceive their pain. The left end of the scale represents "no pain" (0 cm), and the right end represents "unbearable pain" (10 cm). Assessment is performed by precisely measuring the horizontal distance of the marked point from the left end with a ruler. This numerical value is interpreted as an indicator of the participant's pain severity. A score between 1-3.9 cm indicates mild pain, 4-6.9 cm indicates moderate pain, and 7-10 cm indicates severe pain.

次要结局

  • Canadian Occupational Performance Measure (COPM)(six months)
  • Nottingham Health Profile (NHP)(six months)
  • Oswestry Disability Index (ODI)(six months)
  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)(six months)
  • Hospital Anxiety and Depression Scale (HADS)(six months)
  • Canadian Occupational Performance Measure (COPM)(six months)
  • Nottingham Health Profile (NHP)(six months)
  • Oswestry Disability Index (ODI)(six months)
  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)(six months)
  • Hospital Anxiety and Depression Scale (HADS)(six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Etkin Bagi

Principal Investigator

Hacettepe University

研究点 (1)

Loading locations...

相似试验