Skip to main content
OpenTrials
Completed

NCT Number: NCT03523793

Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy

This study will investigate implementation of a process to enhance Clinical Practice Guideline (CPG) adherence to limit unwarranted variability in initial treatment decisions with high potential for providing more effective and efficient physical therapy management for patients with neck and low back pain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neck Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

About this study

Effective implementation of CPGs to augment initial clinical decision making during physical therapy management of patients with spine related musculoskeletal pain will have several important goals: 1) improve patient pain and disability outcomes, 2) limit over utilization of physical therapy services, and 3) increase adherence to limit unwarranted variation in clinical practice. This proposed pilot study proposal will test if a multifaceted intervention strategy for implementation of neck and low back CPG meets these goals and provide necessary data for larger system wide implementation efforts.

Specific Aim 1: Determine if physical therapy clinics that receive neck and low back pain (LBP) clinical practice guideline (CPG) training are associated with improved patient outcomes compared to those that have not received training. Neck and LBP specific disability and pain intensity will be assessed at intake, on a weekly basis and at discharge (Specific Aim 1a). Secondary patient outcomes will consist of patient satisfaction scores (Specific Aim 1b). Statistical analyses will evaluate for temporal effects of training considering the stepped wedge study design.

Specific Aim 2: Determine if multifaceted interventions for CPG implementation positively impacts physical therapist beliefs, attitudes, knowledge and behaviors over time. CPG adherence (by clinicians) will be indirectly assessed using quantitative and qualitative methods consisting of: 1) clinician checklists, 2) clinician questionnaires, 3) quality indicators, and 4) total proportion outcome measure assessments (Specific Aim 2).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Receiving outpatient physical therapy for a diagnosis covered in previously published CPGs for neck or LBP
  • Able to read and comprehend English language (necessary for completion of self-report e-forms)

Exclusion criteria

  • Any diagnosis indicating systemic involvement
  • Widespread chronic pain syndrome
  • Neuropathic pain syndromes
  • Neurological disorders.

Treatment and study plan

Clinical Practice Guideline Implementation

Behavioral

The Study team will use several methods from the implementation strategy taxonomy of the Effective Practice and Organization of Care (EPOC) classification system to improve our likelihood for successful neck and low back pain implementation consisting of: 1) educational materials, workshops and outreach visits from trainers; 2) external consultant testimonials; 3) iterative quality improvement processes (including ongoing analysis of clinician feedback to improve process); 4) routine collection of patient reported outcomes to engage discussion among clinician groups and outpatient division leaders) and 5) local organization consensus process (including feedback from key outpatient division stakeholders).

Standard care

Other

Considering the stepped wedge design with a 12-week washout phase, clinics will be providing standard physical therapy prior to receiving clinical practice guideline training.

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 68 weeks

    The Oswestry Disability Index (ODI), which has 10 items that assesses how low back pain affects common daily activities. The ODI has a range of 0% "no disability due to low back pain" to 100% "completely disabled due to low back pain", with higher scores indicating higher disability from low back pain.

  2. Neck Disability Index (NDI)

    Time frame: 68 weeks

    The Neck Disability Index (NDI), which has 10 items that assesses how neck pain affects common daily activities. The NDI has a range of 0% "no disability due to neck pain" to 100% "completely disabled due to neck pain", with higher scores indicating higher disability from neck pain.

  3. Numeric Pain Rating Scale (NPRS)

    Time frame: 68 weeks

    Numeric Pain Rating Scale (NPRS) Pain intensity will be rated using a NPRS, ranging from "0" (no pain) to "10" (worst pain imaginable). Patients will be asked to rate their current pain intensity, as well as their best and worst level of pain intensity over the past 24 hours. These 3 pain ratings will averaged and used as the NPRS variable in this study.

Secondary outcomes

  1. Rehabilitation Outpatient Division Patient Satisfaction Survey

    Time frame: 68 weeks

    To assess overall therapy experience and explanations provided by therapist.

  2. Evidence-Based Practice Questionnaire (EBPQ)

    Time frame: 68 weeks

    The Evidence-Based Practice Questionnaire (EBPQ) to assess clinician beliefs, attitudes, knowledge and self-reported behaviors regarding evidence-based practice and clinical practice guidelines. Responses range from Strongly Agree to Strongly Disagree.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Brooks Rehabilitation
  • Foundation for Physical Therapy Research

Registry information

Official study title

Health System Implementation of Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy Settings

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 14, 2018
Registry last updated
Oct 23, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.