Person-Centered Lifestyle Redesign in Chronic Low Back Pain

NCT ID: NCT07163546

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-04-20

Brief Summary

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.

Conditions

Low Back Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lifestyle intervention and Physical therapy

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

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

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.

The lifestyle intervention was planned as a total of 8 sessions, 2 sessions per week.

Physical therapy

This group only receives physical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 problem-solving skills while experiencing positive lifestyle changes and developing healthy routines.

The lifestyle intervention was planned as a total of 8 sessions, 2 sessions per week.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Etkin Bagi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HU-ERG-EB-02

Identifier Type: -

Identifier Source: org_study_id