The Effect of Exercise on Recent Onset Low Back Pain in the Emergency Department

NCT03756519 | Completed

• 1 other identifier: REH-715-18
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is the leading contributor to years lived with disability and an important contributor to healthcare costs and time off work. Exercise is effective for chronic low back pain, but there is a lack of evidence to inform whether exercise in the emergency department is effective for people with acute low back pain. This randomized controlled trial will evaluate the effectiveness of a brief exercise intervention provided in the emergency department for people with recent onset low back pain. People with acute low back pain (\<1 week) will be randomly assigned to either usual care or to usual care plus a brief exercise intervention delivered by trained physiotherapy students. The study will evaluate the impact of the added exercises on self-reported disability (primary outcome), pain intensity, global rating of change, patient satisfaction, and adverse events. In addition, we will pilot data collection related to return to work, healthcare utilization, and cost effectiveness outcomes to determine the feasibility of conducting a future trial with additional patient participants required to evaluate these outcomes. Outcomes will be evaluated at baseline, 48-72 hours, 1-week, 1-month, and 3-months from their initial emergency department visit. The results of this study have the potential to inform emergency department management of acute low back pain.

Conditions

Low Back Pain

Keywords

acute; exercise; emergency department

Outcome Measures

Primary Outcomes (1)

• Self-reported disability

  Roland Morris Questionnaire (0-24, higher represents greater disability)

  Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week

Secondary Outcomes (17)

• Pain Intensity currently

  Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week

• Pain intensity on average over past 24-hours

  Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week

• Pain intensity at its worst over the past 24-hours

  Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week

• Pain intensity at its least over the past 24-hours

  Change from baseline to 3-months with repeated measures at baseline, 1-week, 1-month, 3-months and a primary comparison at 1-week

• Global rating of change

  1-week, 1-month, 3-months with a primary comparison at 1-week

Study Arms (2)

Exercise

EXPERIMENTAL

Participants in the exercise intervention arm will receive the usual care protocol plus a standardized, evidence informed exercise intervention provided by trained physiotherapy students. The exercise intervention will begin with a brief assessment to rule out contraindications to exercise and to identify any directional preferences (e.g. pain with lumbar flexion and relief with extension). The PT will then be taught four standardized exercises: the pelvic tilt exercise, a rotational exercise, a tailored graded walking program taking into account the current abilities of the patient, and an exercise based on the directional preference of the individual. These will be re-enforced with a handout including the rationale, instructions and dosage recommendations for the exercises.

Behavioral: Exercise; Behavioral: Advice to stay active and engaged in usual activities.; Behavioral: Advice on use of ice or heat; Other: Advise regarding use of medications

Usual care

ACTIVE COMPARATOR

Our usual care protocol was developed based on 30 responses to an 18 item survey of Queen's Department of Emergency Medicine physicians. Three themes emerged as interventions most commonly used. Each of these strategies has evidence for small, but positive treatment effects and low risk of harms: 1) advice to stay active and engaged in usual activities, 2) use of ice or heat to manage pain, and 3) recommendation for analgesia using NSAIDs if needed and appropriate.

Behavioral: Advice to stay active and engaged in usual activities.; Behavioral: Advice on use of ice or heat; Other: Advise regarding use of medications

Interventions

Exercise BEHAVIORAL

A standardized exercise program tailored to the individual based on their directional preferences and current functional abilities.

Exercise

Advice to stay active and engaged in usual activities. BEHAVIORAL

Participants will be advised that staying physically active and continuing to participate in usual activities improves recovery. This verbal advice will be reinforced with a written handout.

Exercise; Usual care

Advice on use of ice or heat BEHAVIORAL

Participants will be advised on the appropriate use of ice or heat to manage pain. This verbal advice will be reinforced with a written handout.

Exercise; Usual care

Advise regarding use of medications OTHER

Participants will receive education regarding the use of non-steroidal anti-inflammatory medications (NSAIDs) for pain relief, if needed and if the patient is appropriate for NSAIDs. Information regarding specific recommended doses, potential benefit and risk will be discussed.

Exercise; Usual care

Eligibility Criteria

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

You may qualify if:

• English speaking
• Adults (18-65 years)
• Recent onset low back pain (\<1 week)

You may not qualify if:

• Subacute/chronic LBP (\> 1week)
• Previous episode of low back pain in past 3 months
• fracture
• previous back surgery
• urinary retention
• saddle anaesthesia
• bilateral or multilevel neurological impairment
• traumatic mechanism of injury (fall \>3m or 3 steps, MVC \>100km/h).

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston Health Sciences Center - Kingston General Hospital and Hotel Dieu Hospital Sites

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Emergencies

Interventions

Exercise; Hot Temperature

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Jordan Miller, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Robert Brison, MD

  Kingston Health Sciences Center and Queen's University

  PRINCIPAL INVESTIGATOR

• Elizabeth Blackmore, MD

  Kingston Health Sciences Center

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The patient will be partially blinded by our not providing full details on the two interventions being studied. Participants will be instructed that, "Participants in this study will be randomized (chosen as by a coin flip) to receive one of two different types of advice and instruction on maintaining mobility and performing exercise."

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: November 28, 2018
• Study Start: May 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)