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

Primary Purpose

Neck Pain, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Practice Guideline Implementation
Standard Care
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neck Pain focused on measuring Outpatient Physical Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brooks Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Therapists - CPG

Physical Therapists - Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Rehabilitation Outpatient Division Patient Satisfaction Survey
To assess overall therapy experience and explanations provided by therapist.
Evidence-Based Practice Questionnaire (EBPQ)
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.

Full Information

First Posted
May 2, 2018
Last Updated
October 19, 2023
Sponsor
University of Florida
Collaborators
Foundation for Physical Therapy Research, Brooks Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT03523793
Brief Title
Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy
Official Title
Health System Implementation of Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy Settings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Foundation for Physical Therapy Research, Brooks Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Low Back Pain
Keywords
Outpatient Physical Therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cross-sectional stepped wedge design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapists - CPG
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Therapists - Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Practice Guideline Implementation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
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 Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
68 weeks
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
68 weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
68 weeks
Secondary Outcome Measure Information:
Title
Rehabilitation Outpatient Division Patient Satisfaction Survey
Description
To assess overall therapy experience and explanations provided by therapist.
Time Frame
68 weeks
Title
Evidence-Based Practice Questionnaire (EBPQ)
Description
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.
Time Frame
68 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Beneciuk, DPT,PhD,MPH
Organizational Affiliation
University of Florida; Brooks Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooks Rehabilitation
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35100820
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35100820/
Description
Primary Results

Learn more about this trial

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

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