An interventional study of physiotherapeutic intervention in Lower Back Pain, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 126 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
"Red Flags" at time of ED-presentation:
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 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.
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.
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.
Time frame: At Day 0 and at Day 7 ± 7 days
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"))
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland