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

Lower Back Pain Clinical Trial

— EPAC-II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156957
• Other study ID #: 2021-02166; am21Bingisser
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 11, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Emergencies
• Low Back Pain
• Lower Back Pain

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Emergency Department University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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