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Clinical Trials/NCT05156957
NCT05156957
Completed
Not Applicable

Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain. A Brief Intervention Focusing on Patient Reported Outcomes

University Hospital, Basel, Switzerland1 site in 1 country126 target enrollmentJanuary 5, 2022
ConditionsLower Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Back Pain
Sponsor
University Hospital, Basel, Switzerland
Enrollment
126
Locations
1
Primary Endpoint
Oswestry Disability Index (ODI)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Physiotherapy is a long established therapy in lower back pain. It is unknown if physiotherapeutic interventions in patients presenting to the Emergency Department (ED) with nonspecific lower back pain are beneficial. The aim of this study is to assess whether patients presenting to the emergency department with non-specific low risk low back pain would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at time of ED presentation.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
August 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Written informed consent
  • Experiencing nonspecific lower back pain
  • Presentation to the Emergency Department (ED) of the University Hospital Basel

Exclusion Criteria

  • Inpatient disposition after ED work-up
  • "Red Flags" at time of ED-presentation:
  • Major trauma in all patients
  • Fractures leading to immobilization
  • Severe or progressive sensory alteration or weakness
  • Bladder or bowel dysfunction
  • Evidence of neurological deficit on physical examination
  • Severe chronic disease, such as metastasized cancer, palliative care
  • Epidural steroid injections in the last 3 months
  • Inability or contraindications to undergo the investigated intervention or to follow the study procedures, e.g. due to certain neurological disorders, language problems, psychological disorders, cognitive impairment, physical inability etc.

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

Time Frame: At Day 0 and at Day 7 ± 7 days

This self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Secondary Outcomes

  • Oswestry Disability Index (ODI)(Day 21 ± 3 days, Day 42 ± 3 days)
  • Pain Numeric Rating Scale (NRS)(At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Adherence to therapy recommendations(At Day 7 ± 7 days)
  • StarT Back Screening Tool (SBST)(Day 0, Day 7 ± 7 days, Day 42 ± 3 days)
  • Feasibility of the intervention(At Day 0)
  • Utilization of medical resources(At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Ability to work(At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Patient satisfaction(At Day 7 ± 7 days)
  • Pain medication use(At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)

Study Sites (1)

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