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

NCT03523793 | Completed

• 3 other identifiers: IRB2018005690045970 (710850-6)00000775
• Study Type: interventional
• Target: 1,441
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain; Low Back Pain

Keywords

Outpatient Physical Therapy

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Index (ODI)

  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.

  68 weeks

• Neck Disability Index (NDI)

  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.

  68 weeks

• Numeric Pain Rating Scale (NPRS)

  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.

  68 weeks

Secondary Outcomes (2)

• Rehabilitation Outpatient Division Patient Satisfaction Survey

  68 weeks

• Evidence-Based Practice Questionnaire (EBPQ)

  68 weeks

Study Arms (2)

Physical Therapists - CPG

EXPERIMENTAL

Cross-sectional stepped wedge design with 16 physical therapy clinics (including approximately 40 physical therapists) being allocated to one of 4 sequences that differ in CPG implementation time (each sequence consisting of 4 clinics). This proposed study will be conducted over 68 weeks, with the initial 12 weeks serving as a baseline washout phase (before any clinic has received training), then 4 clinics crossing over from standard care (control) to CPG and decision support tool implementation (intervention) approximately every 8 weeks until week 44 when all 4 sequences (16 clinics) have completed training.

Behavioral: Clinical Practice Guideline Implementation

Physical Therapists - Control

ACTIVE COMPARATOR

This proposed study will be conducted over 68 weeks, with the initial 12 weeks serving as a baseline washout phase (before any clinic has received training), then 4 clinics crossing over from standard care (control) to CPG and decision support tool implementation (intervention) approximately every 8 weeks until week 44 when all 4 sequences (16 clinics) have completed training.

Other: Standard Care

Interventions

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).

Physical Therapists - CPG

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.

Physical Therapists - Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• Foundation for Physical Therapy Research: collaborator
• Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

Related Publications (1)

• Beneciuk JM, Osborne R, Hagist MB, Crittenden J, Buzzanca KE, Gao H, Wu SS. American Physical Therapy Association Clinical Practice Guideline Implementation for Neck and Low Back Pain in Outpatient Physical Therapy: A Nonrandomized, Cross-sectional Stepped-Wedge Pilot Study. J Orthop Sports Phys Ther. 2022 Feb;52(2):113-123. doi: 10.2519/jospt.2022.10545.

  PMID: 35100820 BACKGROUND

Related Links

• Primary Results

MeSH Terms

Conditions

Neck Pain; Low Back Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jason Beneciuk, DPT,PhD,MPH

  University of Florida; Brooks Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross-sectional stepped wedge design

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: August 14, 2018
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)