Person-Centered Lifestyle Redesign in Chronic Low Back Pain

NCT07163546 | Enrolling By Invitation DMC

• 1 other identifier: HU-ERG-EB-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Chronic

Keywords

pain; quality of life; disability; physical activity; mental status; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  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.

  six months

Secondary Outcomes (5)

• 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

Study Arms (2)

Lifestyle intervention and Physical therapy

EXPERIMENTAL

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

Behavioral: Lifestyle intervention

Physical therapy

NO INTERVENTION

This group only receives physical therapy

Interventions

Lifestyle intervention 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.

Lifestyle intervention and Physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 15, 2025
• Primary Completion: November 20, 2025
• Study Completion: April 20, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)