Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain (EPAC-II)

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Back Pain
• Intervention / Treatment: Other: physiotherapeutic intervention

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henk B. Riedel; Phone Number: +41 61 556 53 24; Email: Henk.Riedel@usb.ch, physiostudie@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Emergency Department University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; The study intervention is a brief physiotherapeutic assessment, a brief information on the expected course of the condition, and a brief instruction on self-management, including three exercises for daily self-guided therapy.	Other: physiotherapeutic intervention; The intervention consists of a brief physiotherapeutic assessment by a short physical performance battery, a brief information on the expected course of the condition and instructions on self-management regarding back friendly behaviour (eg. respecting the pain, staying active and back friendly movement strategies). Additionally, three exercises for daily self-guided therapy are included to the intervention: Turning in bed and coming to a sitting position, sit to stand and squats standing in front of a wall.
No Intervention: control group; The control group will receive written information on the expected course of the condition, written instructions on self-management and written instructions on exercises for daily self-guided therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	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.	At Day 0 and at Day 7 ± 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Numeric Rating Scale (NRS)	The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain ('0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine"))	At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Feasibility of the intervention	The questionnaire was completed by the physiotherapist after the intervention and consisted of six questions about the feasibility of the physiotherapeutic intervention. Each question had a scale of 1 (= no, strongly disagree) to 6 (=yes, strongly agree) for possible answers.	At Day 0
Patient satisfaction	This self-completed questionnaire contains six questions about patient satisfaction with their ED visit on day 0. Each question could be answered with a score from 0 (not at all) to 10 (very much).	At Day 7 ± 7 days
Adherence to therapy recommendations	Patients were asked if they were able to adhere to the behavioral and exercise recommendations given to them on Day 0.	At Day 7 ± 7 days
StarT Back Screening Tool (SBST)	The SBST categorises back pain patients into 3 categories: low, medium and high risk. It consists of 9 items, each with a value of 0 or 1 points. The SBST Score is calculated by summing the points from each question, with a minimum score of 0 points and a maximum score of 9 points.	Day 0, Day 7 ± 7 days, Day 42 ± 3 days
Oswestry Disability Index (ODI)	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.	Day 21 ± 3 days, Day 42 ± 3 days
Pain medication use	Questions about the use of pain medication and how long pain medication have been used.	At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Utilization of medical resources	Patients were asked if they had seen a physiotherapist, an emergency department, a general practitioner, a specialist, been hospitalized or had imaging since the last contact.	At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Ability to work	Patients were asked if they were going back to work.	At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Roland Bingisser, Prof. Dr. med., Emergency Department University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Oswestry Disability Index (ODI); physiotherapy intervention; nonspecific lower back pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Back Pain; Low Back Pain
• Other Study ID Numbers: 2021-02166; am21Bingisser

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No