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Completed

NCT Number: NCT05221125

Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)

The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge.

We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital Emergency Department

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults (age 18 years or older),
  • Presented to the ED with pain in the neck and/or back,
  • A diagnosis of musculoskeletal pain as determined by an ED provider,
  • Able to read and understand the consent form in English.

Exclusion criteria

  • Suspected to have a non-musculoskeletal cause of pain;
  • Unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment;
  • Unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active COVID-19 infection),
  • ED provider judgment.

Treatment and study plan

Psychologically-Informed Physical Therapy (PIPT)

Behavioral

The PIPT group will receive evaluation and treatment based on the PT's assessment of the individual patient's clinical presentation and condition.

Primary outcomes

  1. Number of ED patients eligible for recruitment as measured by patient log

    Time frame: Post implementation, up to 6 weeks

  2. Number of patients enrolled as measured by patient log

    Time frame: Post implementation, up to 6 weeks

  3. Number of patients retained in study as measured by patient log

    Time frame: Post implementation, up to 6 weeks

  4. Number of patients that found treatment satisfactory via satisfactory questionnaire

    Time frame: Post implementation, up to 6 weeks

    5 point Likert-scale satisfaction scale

Secondary outcomes

  1. Change in Pain Score

    Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

    11-point Numeric Rating Scale (NRS) for current pain

  2. Change in Anxiety Level

    Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

    Subjective Units of Discomfort Scales (SUDS)

  3. Change in Function

    Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

    PROMIS-29

  4. Change in Quality of Life (QoL)

    Time frame: ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge

    PROMIS-29

  5. Change in pain related distress

    Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge

    Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool

  6. Change in self efficacy

    Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge

    Optimal Screening for Prediction of Referral and Outcome (OSPRO) tool

  7. Change in severity of chronic pain

    Time frame: ED pre-treatment (baseline); 1 and 3 months post discharge

    Simplified graded chronic pain scale

  8. Number of pain medications prescribed

    Time frame: up to 3 months post discharge

    as measured by chart review

  9. Number of Spine Health referrals for follow up PT

    Time frame: At ED discharge (up to 48 hours)

    as measured by chart review

  10. Number of Spine Health visits for follow up PT

    Time frame: up to 3 months post discharge

    as measured by chart review

  11. Number of repeat ED visits

    Time frame: up to 3 months post discharge

    as measured by chart review

  12. Number of patient hospitalizations

    Time frame: up to 3 months post discharge

    as measured by chart review

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Clinical Research Institute

Registry information

Official study title

Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2022
Registry last updated
Mar 6, 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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