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Enrolling by invitation NCT07163546

Person-Centered Lifestyle Redesign in Chronic Low Back Pain

No phase Interventional Low Back Pain, Chronic

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
The protocol lists: Lifestyle intervention.
Who it may be relevant to
Registry conditions: Low Back Pain, Chronic. Basic parameters: 18 years — 65 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 →
Official title

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

Overview

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.

Detailed description

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.

A lifestyle intervention is an occupational therapy intervention program that aims to help individuals change their lifestyle by encouraging greater engagement in meaningful activities. This program aims to help participants develop healthy routines and habits. It offers a perspective that combines various approaches such as patient education, occupational self-analysis, problem-solving, and building motivation to prevent and manage chronic health problems. Participants gain self-analysis and problem-solving skills while experiencing positive lifestyle changes and developing healthy routines.

Our study was planned to investigate 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, due to the limited number of studies conducted on this subject.

Interventions

  • Behavioral Lifestyle intervention
    A lifestyle intervention is an occupational therapy intervention program that aims to help individuals change their lifestyle by encouraging greater engagement in meaningful activities. This program aims to help participants develop healthy routines and habits. It offers a perspective that combines various approaches such as patient education, occupational self-analysis, problem-solving, and building motivation to prevent and manage chronic health problems. Participants gain self-analysis and pr

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: six months]
Secondary outcome measures (5)
  • Canadian Occupational Performance Measure (COPM) [Time frame: six months]
  • Nottingham Health Profile (NHP) [Time frame: six months]
  • Oswestry Disability Index (ODI) [Time frame: six months]
  • International Physical Activity Questionnaire - Short Form (IPAQ-SF) [Time frame: six months]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: six months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University — Ankara

Identifiers

NCT: NCT07163546 · HU-ERG-EB-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗