Back to resultsEffect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain (EPAC-II)
Primary Purpose
Lower Back Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
physiotherapeutic intervention
Sponsored by
About this trial
This is an interventional treatment trial for Lower Back Pain focused on measuring physiotherapy intervention, Oswestry Disability Index (ODI), nonspecific lower back pain
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.
- Prior enrolment in this trial
Sites / Locations
- Emergency Department University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in 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.
Secondary Outcome Measures
Change in Pain Numeric Rating Scale (NRS)
The NPRS 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"))
Change in 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.
Change in 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.
Full Information
NCT ID
NCT05156957
First Posted
November 29, 2021
Last Updated
September 20, 2023
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT05156957
Brief Title
Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
physiotherapy intervention, Oswestry Disability Index (ODI), nonspecific lower back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physiotherapeutic intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI)
Description
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.
Time Frame
At Day 0 and at Day 7 ± 7 days
Secondary Outcome Measure Information:
Title
Change in Pain Numeric Rating Scale (NRS)
Description
The NPRS 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"))
Time Frame
At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Title
Change in StarT Back Screening Tool (SBST)
Description
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.
Time Frame
Day 0, Day 7 ± 7 days, at 3rd follow-up visit (at Day 42 ± 3 days after Baseline)
Title
Change in Oswestry Disability Index (ODI)
Description
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.
Time Frame
At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Prior enrolment in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Bingisser, Prof. Dr. med.
Organizational Affiliation
Emergency Department University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain
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