Low Back Pain, ChronicNCT07163546
Person-Centered Lifestyle Redesign in Chronic Low Back Pain
A study testing Lifestyle intervention in people with Low Back Pain, Chronic, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Chronic
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18-65 years old
- Lower back pain lasting ≥3 months
- Pain at least 4 according to VAS
- Being literate
Who cannot join
- 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,
Show all 10Show fewer
- Severe psychiatric, neurological, infectious, renal or inflammatory disorders,
- Systematic metabolic disorder,
- Pregnancy
- BMI ≥ 30 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Outcomes of the Person-Centered Lifestyle Redesign in Individuals With Chronic Low Back Pain
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.
Read the 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
- Being tested
- Lifestyle intervention
- Keywords
- pain, quality of life, disability, physical activity, mental status, occupational therapy
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention and Physical therapy | Experimental | It is a group that receives physical therapy and lifestyle intervention. Receives: Behavioral: Lifestyle intervention |
| Physical therapy | No intervention | This group only receives physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (5)
Canadian Occupational Performance Measure (COPM)
The COPM is a semi-structured assessment tool that allows individuals to identify performance areas in daily life where they experience problems and to measure their level of occupational performance and satisfaction in these areas. It consists of three sections: self-care, leisure, and productivity. In the first stage, the individual is asked to rate the importance of their activities in these three areas on a scale of 1 to 10 (1: not important at all, 10: extremely important). In the next stage, the individual selects the five activities they identified as most important. For each selected activity, they are asked to rate both their performance (1: my performance is very poor, 10: my performance is very good) and their satisfaction (1: not satisfied at all, 10: extremely satisfied) on a Likert-type scale from 1 to 10. For scoring, the performance scores given for each activity are summed and divided by the number of selected activities to obtain an average
Measured: six months
Nottingham Health Profile (NHP)
The Nottingham Health Profile subjectively evaluates an individual's health status through 38 items across six different dimensions: emotional reactions (9 items), physical mobility (8 items), pain (8 items), sleep (5 items), social isolation (5 items), and energy level (3 items). Participants are required to answer the questions with 'yes' or 'no'. The score for each sub-dimension is calculated on a scale from 0 to 100, and the maximum total score obtained by summing all dimension scores is 600. In the interpretation of the scores, a lower total score is associated with a better quality of life. The reported Cronbach's alpha values for the different sub-dimensions of the scale range from 0.56 to 0.83.
Measured: six months
Oswestry Disability Index (ODI)
The Oswestry Disability Index examines 10 different dimensions affecting daily life: pain intensity, personal care, lifting, walking, sitting, standing, sleep quality, sex life, social life, and traveling. The lowest possible score on the scale is 0, and the highest is 50. The total score is multiplied by 2 to express the individual's disability level as a percentage (%). An increase in the score indicates an increase in the level of disability experienced by the individual due to low back pain. The Cronbach's alpha value of the ODI is 0.89, stating that the scale is highly reliable.
Measured: six months
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
The International Physical Activity Questionnaire - Short Form is to objectively assess individuals' physical activity levels over the last seven days. Consisting of four sections and seven questions, the questionnaire asks the participant to recall and report physical activities performed for at least 10 minutes at a time during the last seven days. The questionnaire collects information on the time spent walking, in moderate-intensity activities, and in vigorous-intensity activities, as well as sedentary time spent sitting. These duration data are converted into a Metabolic Equivalent (MET)-minute/week score to express physical activity in terms of energy expenditure. Standard, internationally accepted MET values are used for this calculation: Walking: 3.3 METs, Moderate Physical Activity: 4.0 METs, Vigorous Physical Activity: 8.0 METs, Sitting: 1.5 METs.
Measured: six months
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale is to screen participants' anxiety and depression levels. The scale consists of 14 items total and comprises two subscales: Anxiety (HADS-A) and Depression (HADS-D), each containing 7 items. Participants are asked to respond to each item on a four-point Likert-type scale ranging from 0 to 3. The score for each subscale ranges from 0 to 21. Higher scores indicate greater severity of symptoms in the respective dimension. The Cronbach's alpha coefficients for the scale were reported as 0.85 for anxiety and 0.77 for depression.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etkin Bagi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163546
- Sponsor's protocol ID
- HU-ERG-EB-02
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Outcomes of the Person-Centered Lifestyle Redesign in Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07163546
- Acronym / sponsor ID
- HU-ERG-EB-02
- Conditions
- Low Back Pain, Chronic
- Keywords
- pain, quality of life, disability, physical activity, mental status, occupational therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention and Physical therapy | Experimental | Behavioral: Lifestyle interventionIt is a group that receives physical therapy and lifestyle intervention. |
| Physical therapy | No intervention | –This group only receives physical therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between 18-65 years old
- Lower back pain lasting ≥3 months
- Pain at least 4 according to VAS
- Being literate
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionA 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. | Behavioural | Lifestyle intervention and Physical therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Low Back Pain, Chronic, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.