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

NCT05156957 | Completed

• 1 other identifier: 2021-02166; am21Bingisser
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain

Keywords

physiotherapy intervention; Oswestry Disability Index (ODI); nonspecific lower back pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At Day 0 and at Day 7 ± 7 days

Secondary Outcomes (9)

• Pain Numeric Rating Scale (NRS)

  At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days

• Feasibility of the intervention

  At Day 0

• Patient satisfaction

  At Day 7 ± 7 days

• Adherence to therapy recommendations

  At Day 7 ± 7 days

• StarT Back Screening Tool (SBST)

  Day 0, Day 7 ± 7 days, Day 42 ± 3 days

Study Arms (2)

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.

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.

Interventions

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Experiencing nonspecific lower back pain
• Presentation to the Emergency Department (ED) of the University Hospital Basel

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Emergency Department University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland Bingisser, Prof. Dr. med.

  Emergency Department University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 14, 2021
• Study Start: January 5, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 11, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CH (1)