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Completed

NCT Number: NCT05156957

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

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.

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Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiotherapeutic intervention

Other

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 outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 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 outcomes

  1. Pain Numeric Rating Scale (NRS)

    Time frame: 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"))

  2. Feasibility of the intervention

    Time frame: 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.

  3. Patient satisfaction

    Time frame: 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).

  4. Adherence to therapy recommendations

    Time frame: 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.

  5. StarT Back Screening Tool (SBST)

    Time frame: 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.

  6. Oswestry Disability Index (ODI)

    Time frame: 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.

  7. Pain medication use

    Time frame: 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.

  8. Utilization of medical resources

    Time frame: 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.

  9. Ability to work

    Time frame: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days

    Patients were asked if they were going back to work.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: EPAC-II

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2021
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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