- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07648927
Evaluation of the Effectiveness of Physical Therapy for Low Back Pain According to Magnetic Resonance Imaging Findings
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: zeynep Iyigun, Prof. MD
- Telefonnummer: +905056987368
- E-post: znperdogan@gmail.com
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Bahcesehir University
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Ta kontakt med:
- Zeynep İyigün
- Telefonnummer: +905056987368
- E-post: znperdogan@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Patients with Low Back Pain Receiving Standard Physical Therapy
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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in disability measured by the Oswestry Disability Index (ODI)
Tidsramme: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).
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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.
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Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in pain intensity measured by the Visual Analog Scale (VAS)
Tidsramme: Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)
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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.
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Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BAU-FTR-2026-07/03
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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