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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05156957

Collaborator

(none)

140

Enrollment

Location

Arms

10.8

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Back Pain	Other: physiotherapeutic intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in 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

Change in Pain Numeric Rating Scale (NRS) [At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days]
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) [Day 0, Day 7 ± 7 days, at 3rd follow-up visit (at Day 42 ± 3 days after Baseline)]
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) [At Day 0, Day 7 ± 7 days, 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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