Clinical trial NCT05156957: Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain
Official title: Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain. A Brief Intervention Focusing on Patient Reported Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Keywords: physiotherapy intervention
Oswestry Disability Index (ODI)
nonspecific lower back pain
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  1. Major trauma in all patients
  2. Fractures leading to immobilization
  3. Severe or progressive sensory alteration or weakness
  4. Bladder or bowel dysfunction
  5. Evidence of neurological deficit on physical examination
  6. 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.
* Prior enrolment in this trial

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: At Day 0 and at Day 7 ± 7 days
Secondary outcomes:
measure: Pain Numeric Rating Scale (NRS)
timeFrame: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
measure: Feasibility of the intervention
timeFrame: At Day 0
measure: Patient satisfaction
timeFrame: At Day 7 ± 7 days
measure: Adherence to therapy recommendations
timeFrame: At Day 7 ± 7 days
measure: StarT Back Screening Tool (SBST)
timeFrame: Day 0, Day 7 ± 7 days, Day 42 ± 3 days
measure: Oswestry Disability Index (ODI)
timeFrame: Day 21 ± 3 days, Day 42 ± 3 days
measure: Pain medication use
timeFrame: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
measure: Utilization of medical resources
timeFrame: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
measure: Ability to work
timeFrame: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Emergency Department University Hospital Basel
Study officials:
affiliation: Emergency Department University Hospital Basel
name: Roland Bingisser, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: