NCT07648927

Brief 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. 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 240 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 six MRI-based groups: disc herniation, disc degeneration, Modic changes, facet arthropathy, spinal stenosis, 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

June 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity measured by the Visual Analog Scale (VAS) from pre-treatment to post-treatment (after completion of 15 sessions of physical therapy).

    Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).

Study Arms (1)

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.

Procedure: Standard Physical Therapy Program

Interventions

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.

Patients with Low Back Pain Receiving Standard Physical Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir university

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DegenerationIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Central Study Contacts

zeynep Iyigun, Prof. MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof., MD

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 15, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional regulations.

Locations