Low Back PainNCT07648927
Evaluation of the Effectiveness of Physical Therapy for Low Back Pain According to Magnetic Resonance Imaging Findings
A study testing Standard Physical Therapy Program in people with Low Back Pain and Physical Therapy, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a common musculoskeletal disorder associated with substantial disability and reduced quality of life. Although magnetic resonance imaging (MRI) is frequently used to identify structural spinal abnormalities, the relationship between MRI findings and treatment outcomes remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Physical Therapy, Lumbar Degenerative Disc Disease
- What is being tested?
- Standard Physical Therapy Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 10 Sep 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
- Age between 18 and 65 years.
- Completion of 15 sessions of physical therapy.
- Availability of accessible MRI images in the medical records.
- No history of lumbar spine surgery.
- Absence of conditions that may cause low back pain, including fibromyalgia, neuropathy, spondyloarthropathy, or scoliosis.
Who cannot join
- Presence of comorbid conditions that may cause low back pain (fibromyalgia, rheumatologic diseases, scoliosis, herpes zoster, polyneuropathy, central pain syndromes).
- Presence of systemic neuromuscular disorders.
- Acute disc herniation or vertebral fracture.
- Receipt of fewer or more than 15 sessions of physical therapy.
- Missing data in follow-up records.
- Use of analgesic medications during the treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bahcesehir university
Istanbul
Zeynep İyigün, +905056987368, znperdogan@gmail.com
About this study
Low back pain is a common musculoskeletal disorder associated with substantial disability and reduced quality of life. Although magnetic resonance imaging (MRI) is frequently used to identify structural spinal abnormalities, the relationship between MRI findings and treatment outcomes remains unclear. This retrospective study aims to evaluate whether the effectiveness of a standardized physical therapy program differs according to baseline lumbar MRI findings. Medical records of 120 patients with low back pain who underwent lumbar MRI and completed 15 sessions of physical therapy between January 2022 and February 2026 will be reviewed. Patients will be classified into three MRI-based groups: disc herniation, disc degeneration, and non-specific MRI findings. Treatment outcomes will be assessed using changes in Visual Analog Scale (VAS) pain scores and Oswestry Disability Index (ODI) scores before and after treatment. The findings may contribute to identifying patient subgroups that respond differently to conservative treatment and support more individualized rehabilitation strategies.
Read the detailed description
Low back pain is one of the leading causes of disability worldwide and represents a major public health burden. Magnetic resonance imaging (MRI) is commonly used to evaluate lumbar spine pathologies such as disc herniation, disc degeneration, Modic changes, facet joint arthropathy, and spinal stenosis. However, previous studies have demonstrated that many degenerative MRI findings are also present in asymptomatic individuals, raising questions regarding their clinical significance and prognostic value.
Physical therapy is a cornerstone of conservative management for low back pain and has been shown to improve pain and functional outcomes. Nevertheless, treatment response varies considerably among patients, and factors influencing these differences remain incompletely understood. Baseline MRI findings may represent one potential predictor of treatment outcome, yet studies investigating this relationship are limited.
The present retrospective study will evaluate whether treatment outcomes following a standardized physical therapy program differ according to lumbar MRI findings. Medical records of patients aged 18-65 years who presented with low back pain to the Physical Medicine and Rehabilitation Clinic of Medical Park Göztepe Hospital between January 2022 and February 2026 will be reviewed. Eligible patients must have undergone lumbar MRI and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS).
Patients will be categorized into three MRI groups: disc herniation, disc degeneration and non-specific MRI findings. MRI images will be reviewed and classified by an experienced physiatrist. Pain intensity and functional disability routinely recorded before and after treatment using the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) will be extracted from medical records.
The primary outcome will be the change in VAS pain score following treatment. Secondary outcomes will include changes in ODI scores. Comparisons of treatment response among MRI groups will be performed using appropriate parametric or non-parametric statistical tests. Multivariable regression analyses will be conducted to determine whether MRI findings independently predict treatment outcomes after adjustment for potential confounding factors.
The results of this study may improve understanding of the prognostic value of lumbar MRI findings and contribute to the development of more personalized rehabilitation approaches for patients with low back pain.
- Being tested
- Standard Physical Therapy Program
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical Therapy ProgramProcedure or surgery
Participants received a standardized physical therapy program consisting of 15 treatment sessions. The treatment protocol included hot pack application, therapeutic ultrasound, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS). All interventions were administered as part of routine clinical care for low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Low Back Pain Receiving Standard Physical Therapy | Other | Patients aged 18-65 years who presented with low back pain, underwent lumbar MRI examination, and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS). Participants will be retrospectively classified according to baseline MRI findings into disc herniation, disc degeneration, Modic changes, facet arthropathy, spinal stenosis, and non-specific MRI groups for outcome analyses. Receives: Procedure: Standard Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disability measured by the Oswestry Disability Index (ODI)
Functional disability will be assessed using the Oswestry Disability Index (ODI), which ranges from 0 to 100, where higher scores indicate greater disability and worse functional status. A reduction in score indicates improvement. The outcome measure will be the change in ODI score from baseline to completion of the 15-session physical therapy program.
Measured: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).
Secondary outcomes (1)
Change in pain intensity measured by the Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A reduction in score indicates improvement. The outcome measure will be the change in VAS score from baseline to completion of the 15-session physical therapy program.
Measured: Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion10 Sep 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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Iyigun, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648927
- Sponsor's protocol ID
- BAU-FTR-2026-07/03
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Physical Therapy for Low Back Pain According to Magnetic Resonance Imaging Findings
- ClinicalTrials.gov ID
- NCT07648927
- Acronym / sponsor ID
- BAU-FTR-2026-07/03
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 15 Jun 2026 (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.
Low back pain is a common musculoskeletal disorder associated with substantial disability and reduced quality of life. Although magnetic resonance imaging (MRI) is frequently used to identify structural spinal abnormalities, the relationship between MRI findings and treatment outcomes remains unclear. This retrospective study aims to evaluate whether the effectiveness of a standardized physical therapy program differs according to baseline lumbar MRI findings. Medical records of 120 patients with low back pain who underwent lumbar MRI and completed 15 sessions of physical therapy between January 2022 and February 2026 will be reviewed. Patients will be classified into three MRI-based groups: disc herniation, disc degeneration, and non-specific MRI findings. Treatment outcomes will be assessed using changes in Visual Analog Scale (VAS) pain scores and Oswestry Disability Index (ODI) scores before and after treatment. The findings may contribute to identifying patient subgroups that respond differently to conservative treatment and support more individualized rehabilitation strategies.
Detailed description
Low back pain is one of the leading causes of disability worldwide and represents a major public health burden. Magnetic resonance imaging (MRI) is commonly used to evaluate lumbar spine pathologies such as disc herniation, disc degeneration, Modic changes, facet joint arthropathy, and spinal stenosis. However, previous studies have demonstrated that many degenerative MRI findings are also present in asymptomatic individuals, raising questions regarding their clinical significance and prognostic value.
Physical therapy is a cornerstone of conservative management for low back pain and has been shown to improve pain and functional outcomes. Nevertheless, treatment response varies considerably among patients, and factors influencing these differences remain incompletely understood. Baseline MRI findings may represent one potential predictor of treatment outcome, yet studies investigating this relationship are limited.
The present retrospective study will evaluate whether treatment outcomes following a standardized physical therapy program differ according to lumbar MRI findings. Medical records of patients aged 18-65 years who presented with low back pain to the Physical Medicine and Rehabilitation Clinic of Medical Park Göztepe Hospital between January 2022 and February 2026 will be reviewed. Eligible patients must have undergone lumbar MRI and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS).
Patients will be categorized into three MRI groups: disc herniation, disc degeneration and non-specific MRI findings. MRI images will be reviewed and classified by an experienced physiatrist. Pain intensity and functional disability routinely recorded before and after treatment using the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) will be extracted from medical records.
The primary outcome will be the change in VAS pain score following treatment. Secondary outcomes will include changes in ODI scores. Comparisons of treatment response among MRI groups will be performed using appropriate parametric or non-parametric statistical tests. Multivariable regression analyses will be conducted to determine whether MRI findings independently predict treatment outcomes after adjustment for potential confounding factors.
The results of this study may improve understanding of the prognostic value of lumbar MRI findings and contribute to the development of more personalized rehabilitation approaches for patients with low back pain.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Low Back Pain Receiving Standard Physical Therapy | Other | Procedure: Standard Physical Therapy ProgramPatients aged 18-65 years who presented with low back pain, underwent lumbar MRI examination, and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS). Participants will be retrospectively classified according to baseline MRI findings into disc herniation, disc degeneration, Modic changes, facet arthropathy, spinal stenosis, and non-specific MRI groups for outcome analyses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Completion of 15 sessions of physical therapy.
- Availability of accessible MRI images in the medical records.
- No history of lumbar spine surgery.
- Absence of conditions that may cause low back pain, including fibromyalgia, neuropathy, spondyloarthropathy, or scoliosis.
Key exclusion criteria (6 listed)
- Presence of comorbid conditions that may cause low back pain (fibromyalgia, rheumatologic diseases, scoliosis, herpes zoster, polyneuropathy, central pain syndromes).
- Presence of systemic neuromuscular disorders.
- Acute disc herniation or vertebral fracture.
- Receipt of fewer or more than 15 sessions of physical therapy.
- Missing data in follow-up records.
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 |
|---|---|---|
| Standard Physical Therapy ProgramParticipants received a standardized physical therapy program consisting of 15 treatment sessions. The treatment protocol included hot pack application, therapeutic ultrasound, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS). All interventions were administered as part of routine clinical care for low back pain. | Procedure or surgery | Patients with Low Back Pain Receiving Standard Physical Therapy |
Primary outcome
Change in disability measured by the Oswestry Disability Index (ODI)
Time frame: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).
Functional disability will be assessed using the Oswestry Disability Index (ODI), which ranges from 0 to 100, where higher scores indicate greater disability and worse functional status. A reduction in score indicates improvement. The outcome measure will be the change in ODI score from baseline to completion of the 15-session physical therapy program.
1 secondary outcome
Change in pain intensity measured by the Visual Analog Scale (VAS)
Time frame: Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)
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 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physical Therapy Program in people with Low Back Pain and Physical Therapy, run by Bahçeşehir 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jun 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?
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?
Contact zeynep Iyigun, Prof. MD (+905056987368, znperdogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disability measured by the Oswestry Disability Index (ODI) (time frame: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).). 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 16 Jun 2026.