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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03523793
Enrollment
1441
Registered
2018-05-14
Start date
2018-08-14
Completion date
2022-03-08
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Neck Pain

Keywords

Outpatient Physical Therapy

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).

Interventions

BEHAVIORALClinical Practice Guideline Implementation

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).

OTHERStandard Care

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.

Sponsors

Foundation for Physical Therapy Research
CollaboratorOTHER
Brooks Rehabilitation
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

cross-sectional stepped wedge design

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index (ODI)68 weeksThe 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)68 weeksThe 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)68 weeksNumeric 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

MeasureTime frameDescription
Rehabilitation Outpatient Division Patient Satisfaction Survey68 weeksTo assess overall therapy experience and explanations provided by therapist.
Evidence-Based Practice Questionnaire (EBPQ)68 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026