Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain

Not Applicable

Completed

• Conditions: Lower Back Pain
• Interventions: Other: physiotherapeutic intervention

• Registration Number: NCT05156957
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-14
• Study Start: 2022-01-05
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	physiotherapeutic intervention	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.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	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 Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Day 21 ± 3 days, Day 42 ± 3 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.
Pain Numeric Rating Scale (NRS)	At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	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"))
Adherence to therapy recommendations	At Day 7 ± 7 days	Patients were asked if they were able to adhere to the behavioral and exercise recommendations given to them on Day 0.
StarT Back Screening Tool (SBST)	Day 0, Day 7 ± 7 days, Day 42 ± 3 days	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.
Feasibility of the intervention	At Day 0	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.
Utilization of medical resources	At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	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.
Ability to work	At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	Patients were asked if they were going back to work.
Patient satisfaction	At Day 7 ± 7 days	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).
Pain medication use	At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days	Questions about the use of pain medication and how long pain medication have been used.

Trial Locations

Locations (1)

Emergency Department University Hospital Basel; 🇨🇭 Basel, Switzerland