Lower Back PainEPAC-IINCT05156957
Effect of Physiotherapy in Patients Presenting to the Emergency Department With Nonspecific Lower Back Pain
A study testing physiotherapeutic intervention in people with Lower Back Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- physiotherapeutic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jan 2022to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Experiencing nonspecific lower back pain
- Presentation to the Emergency Department (ED) of the University Hospital Basel
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Emergency Department University Hospital Basel
Basel, 4031
About this study
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
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.
- Conditions
- Lower Back Pain
- Being tested
- physiotherapeutic intervention
- Keywords
- physiotherapy intervention, Oswestry Disability Index (ODI), nonspecific lower back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapeutic interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Other: physiotherapeutic intervention |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 0 and at Day 7 ± 7 days
Secondary outcomes (9)
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"))
Measured: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
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.
Measured: At Day 0
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).
Measured: At Day 7 ± 7 days
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.
Measured: At Day 7 ± 7 days
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.
Measured: Day 0, Day 7 ± 7 days, Day 42 ± 3 days
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.
Measured: Day 21 ± 3 days, Day 42 ± 3 days
Pain medication use
Questions about the use of pain medication and how long pain medication have been used.
Measured: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
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.
Measured: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Ability to work
Patients were asked if they were going back to work.
Measured: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start5 Jan 2022
- Primary completion30 Jun 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Bingisser, Prof. Dr. med., Principal investigator, Emergency Department University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156957
- Sponsor's protocol ID
- 2021-02166; am21Bingisser
- Acronym
- EPAC-II
- Status last verified
- Mar 2024
- First submitted
- 29 Nov 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05156957
- Acronym / sponsor ID
- EPAC-II / 2021-02166; am21Bingisser
- Conditions
- Lower Back Pain
- Keywords
- physiotherapy intervention, Oswestry Disability Index (ODI), nonspecific lower back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: physiotherapeutic interventionThe 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Experiencing nonspecific lower back pain
- Presentation to the Emergency Department (ED) of the University Hospital Basel
Key exclusion criteria (11 listed)
- Inpatient disposition after ED work-up
- "Red Flags" at time of ED-presentation:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapeutic interventionThe 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. | Other | intervention group |
Primary outcome
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.
9 secondary outcomes
Pain Numeric Rating Scale (NRS)
Time frame: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Feasibility of the intervention
Time frame: At Day 0
Patient satisfaction
Time frame: At Day 7 ± 7 days
Adherence to therapy recommendations
Time frame: At Day 7 ± 7 days
StarT Back Screening Tool (SBST)
Time frame: Day 0, Day 7 ± 7 days, Day 42 ± 3 days
Oswestry Disability Index (ODI)
Time frame: Day 21 ± 3 days, Day 42 ± 3 days
Pain medication use
Time frame: At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Utilization of medical resources
Time frame: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Ability to work
Time frame: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Bingisser, Prof. Dr. med. principal investigator
Emergency Department University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapeutic intervention in people with Lower Back Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: At Day 0 and at Day 7 ± 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.