Low Back PainNCT07150702
Effects of Close Follow-up on Patients With Low Back Pain
A study testing Conventional physical therapy program and Close follow-up by a physician in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will include patients aged 18-65 with subacute or chronic mechanical low back pain who apply to the Physical Medicine and Rehabilitation Clinic. The age, gender, body mass index, duration of low back pain, smoking status, and educational status of the patients included in the study will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Low Back Pain, Mechanical
- What is being tested?
- Conventional physical therapy program and Close follow-up by a physician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients aged 18-65 with subacute or chronic mechanical back pain and considered appropriate for a physical therapy program.
Who cannot join
- Patients describing inflammatory back pain
- Spondyloarthropathies and other rheumatological diseases
- History of spinal surgery
- Patients with sensory disturbances and psychiatric diagnoses
- Fibromyalgia
- Patients with malignancies
- Patients with active infectious findings
- Patients with a history of radiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, Fatih, 34093
About this study
Official title: The Effect of Close Follow-up by a Physician in Addition to a Conventional Physical Therapy Program in Patients With Low Back Pain
This study will include patients aged 18-65 with subacute or chronic mechanical low back pain who apply to the Physical Medicine and Rehabilitation Clinic. The age, gender, body mass index, duration of low back pain, smoking status, and educational status of the patients included in the study will be recorded. Patients will be randomized into two groups: the study group and the control group. First, the psychosocial risk status of patients in both groups will be determined using the STarT Back Screening Tool. Then, patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group. Clinical assessments will be performed using the Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Beck's Depression Scale, Roland-Morris Disability Questionnaire, and Leeds Assessment of Neuropathic Symptoms and Signs. Clinical evaluations will be conducted at baseline, on Day 5 post-treatment, and at 1 month post-treatment.
- Conditions
- Low Back Pain, Low Back Pain, Mechanical
- Being tested
- Conventional physical therapy program, Close follow-up by a physician
- Keywords
- low back pain, physical therapy, mechanical low back pain, pain management
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy programOther
Conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises
Close follow-up by a physicianBehavioural
Daily physician-patient meetings during the sessions
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Conventional physical therapy program | Active comparator | Not described Receives: Other: Conventional physical therapy program |
| Group 2: Conventional physical therapy program with close follow-up by a physician | Active comparator | Not described Receives: Other: Conventional physical therapy program; Behavioral: Close follow-up by a physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
Measured: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Secondary outcomes (5)
Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is an assessment tool typically consisting of 17 items that evaluates how much fear or anxiety individuals experience regarding movement, exercise, or physical activity. The scale ranges from a minimum score of 0 to a maximum score of 51. Higher scores indicate greater kinesiophobia (fear of movement), while lower scores reflect less fear and anxiety.
Measured: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
The Pain Catastrophizing Scale
The Pain Catastrophizing Scale is an assessment tool that evaluates how individuals perceive pain and the level of negative thoughts and anxiety they experience related to pain. The scale typically consists of 13 items, assessing the extent to which a person catastrophizes or experiences excessive worry about their pain. Scores range from a minimum of 0 to a maximum of 52. Higher scores indicate that the individual evaluates pain in a more negative and catastrophic manner, while lower scores suggest lower levels of anxiety and catastrophizing.
Measured: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Beck Depression Inventory
The Beck Depression Inventory is a widely used psychometric tool for assessing the severity of an individual's depression. The scale typically consists of 21 items, each evaluating different emotional, physical, and behavioral symptoms associated with depression. Scores range from a minimum of 0 to a maximum of 63. Higher scores indicate more severe depression symptoms, while lower scores suggest fewer or less intense depressive symptoms.
Measured: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is an assessment tool designed to evaluate the functional limitations and the impact of low back pain on an individual's daily activities. The questionnaire typically consists of 24 items, each exploring how back pain affects physical activities, functionality, and quality of life. Scores range from a minimum of 0 to a maximum of 24. Higher scores indicate greater disability and more significant limitations in daily life due to back pain, while lower scores suggest fewer functional restrictions.
Measured: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Leeds Assessment of Neuropathic Symptoms and Signs
The Leeds Assessment of Neuropathic Symptoms and Signs is an assessment tool designed to evaluate the symptoms of neuropathic pain and the severity of these symptoms. The scale consists of 7 items, each assessing sensory changes, pain type, and the intensity of symptoms related to neuropathic pain. Scores range from a minimum of 0 to a maximum of 24. Higher scores indicate more severe neuropathic pain symptoms, while lower scores suggest milder or no neuropathic pain symptoms.
Measured: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025
- Primary completion20 Aug 2026
- Study completion23 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Model description
- Patients will be randomized into two groups: the study group and the control group. Patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hüdanur Coşkun, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150702
- Sponsor's protocol ID
- 16/05/2025;2011-KAEK-50;114
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Close Follow-up by a Physician in Addition to a Conventional Physical Therapy Program in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT07150702
- Acronym / sponsor ID
- 16/05/2025;2011-KAEK-50;114
- Conditions
- Low Back Pain, Low Back Pain, Mechanical
- Keywords
- low back pain, physical therapy, mechanical low back pain, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 23 Oct 2026 (actual)
- First posted
- 2 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 will include patients aged 18-65 with subacute or chronic mechanical low back pain who apply to the Physical Medicine and Rehabilitation Clinic. The age, gender, body mass index, duration of low back pain, smoking status, and educational status of the patients included in the study will be recorded. Patients will be randomized into two groups: the study group and the control group. First, the psychosocial risk status of patients in both groups will be determined using the STarT Back Screening Tool. Then, patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group. Clinical assessments will be performed using the Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Beck's Depression Scale, Roland-Morris Disability Questionnaire, and Leeds Assessment of Neuropathic Symptoms and Signs. Clinical evaluations will be conducted at baseline, on Day 5 post-treatment, and at 1 month post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups: the study group and the control group. Patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Conventional physical therapy program | Active comparator | Other: Conventional physical therapy program |
| Group 2: Conventional physical therapy program with close follow-up by a physician | Active comparator | Other: Conventional physical therapy program, Behavioral: Close follow-up by a physician |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-65 with subacute or chronic mechanical back pain and considered appropriate for a physical therapy program.
Key exclusion criteria (8 listed)
- Patients describing inflammatory back pain
- Spondyloarthropathies and other rheumatological diseases
- History of spinal surgery
- Patients with sensory disturbances and psychiatric diagnoses
- Fibromyalgia
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 |
|---|---|---|
| Conventional physical therapy programConventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises | Other | Group 1: Conventional physical therapy program, Group 2: Conventional physical therapy program with close follow-up by a physician |
| Close follow-up by a physicianDaily physician-patient meetings during the sessions | Behavioural | Group 2: Conventional physical therapy program with close follow-up by a physician |
Primary outcome
Visual Analog Scale
Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
5 secondary outcomes
Tampa Scale of Kinesiophobia
Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
The Pain Catastrophizing Scale
Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Beck Depression Inventory
Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Roland-Morris Disability Questionnaire
Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Leeds Assessment of Neuropathic Symptoms and Signs
Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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. This study is not recruiting at the moment.
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 Conventional physical therapy program and Close follow-up by a physician in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul Training and Research Hospital 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 27 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.). 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 27 Oct 2026.