NCT06987656

Brief Summary

This retrospective observational study aims to evaluate the effectiveness of physiotherapy interventions-such as manual therapy, electrotherapy (TENS), and individualized exercise programs-in managing acute lumbar spasm in patients presenting to the emergency department. By analyzing medical records from January to June 2024 at Düzce University Faculty of Medicine, the study will compare outcomes between patients receiving only pharmacological treatment and those receiving additional physiotherapy. Primary outcomes include changes in pain levels (measured by Visual Analog Scale), medication usage, patient satisfaction, and re-admission rates within an 8-week follow-up period. The findings aim to inform the integration of physiotherapy into emergency care protocols for acute lumbar spasm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

May 15, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

PhysiotherapyAcute Low Back SpasmEmergency DepartmentManual TherapyExercise TherapyPain Management

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity Measured by Visual Analog Scale (VAS) From Admission to Discharge

    At Emergency Department Admission and at Time of Discharge (up to 12 hours)

    VAS score (0-10 scale)

Secondary Outcomes (1)

  • Level of Patient Satisfaction Recorded at Discharge

    At Discharge (within 12 hours of Emergency Department Admission)

Study Arms (2)

Pharmacologic Treatment Only Group

Patients who received standard pharmacologic treatment only, including NSAIDs, muscle relaxants, and analgesics, without any physiotherapy intervention.

Drug: Standard Pharmacologic Treatment

Pharmacologic + Physiotherapy Group

Patients who received standard pharmacologic treatment along with physiotherapy interventions, including spinal mobilization, electrotherapy (TENS), and individualized exercise programs.

Drug: Standard Pharmacologic TreatmentOther: Physiotherapy Intervention

Interventions

Standard pharmacologic management including nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants (e.g., thiocolchicoside), and analgesics (e.g., paracetamol, tramadol) for acute lumbar spasm.

Pharmacologic + Physiotherapy GroupPharmacologic Treatment Only Group

Physiotherapy interventions included spinal mobilization (Maitland techniques), myofascial release, transcutaneous electrical nerve stimulation (TENS), and personalized exercise programs, as documented in patient medical records.

Pharmacologic + Physiotherapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include adult patients aged 18 to 65 who are admitted to the Emergency Department of Düzce University Faculty of Medicine between June 1, 2025, and December 25, 2025, with a diagnosis of non-specific acute lumbar spasm. The study will retrospectively analyze data from electronic medical records to evaluate physiotherapy and pharmacologic treatment outcomes.

You may qualify if:

  • Adults aged between 18 and 65 years
  • Presented to the emergency department with non-specific acute lumbar spasm
  • No serious pathology on initial evaluation (e.g., infection, malignancy, fracture)
  • No contraindications to physiotherapy or physical activity
  • Agreed to participate in the study and signed the informed consent (if applicable in prospective cases)

You may not qualify if:

  • History of chronic low back pain
  • Presence of neurological deficits (e.g., paresis, paralysis)
  • Diagnosed with serious medical conditions such as infection, malignancy, or spondylodiscitis
  • Pregnancy or contraindications related to reproductive health
  • History of spinal surgery within the past year
  • Cognitive or physical impairments limiting treatment participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University

Düzce, Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (1)

  • Uludag V, Tekin RT, Bogan M, Senguldur E, Demir MC. Integrating physiotherapy into the emergency department for acute low back spasm: a retrospective comparative study. Physiother Theory Pract. 2026 Jan 30:1-10. doi: 10.1080/09593985.2026.2624519. Online ahead of print.

MeSH Terms

Conditions

Musculoskeletal PainEmergenciesAgnosia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 23, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the retrospective nature of the study and the use of sensitive patient information obtained from electronic medical records. The study does not include prior consent for data sharing, and confidentiality regulations prohibit the distribution of such data.

Locations