The Ability of Chronic Pain Patients to Self-diagnose Their Chief Source of Low Back Pain

NCT06630676 | Completed

• 1 other identifier: HRP-593/ v11102023
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

Brief Summary

The investigative team will provide 27 slides with bullet points and images of pain referral patterns for different causes (e.g., herniated disc, facet joint arthritis) for patients seen for a new visit with a chief complaint of chronic low back pain. This material is all publicly available but has been compiled in presentation form. This will have educational benefit for patients, discussing clinical signs and symptoms, risk factors and basic treatments. There will also be a smaller control group of that gets a condensed 4-slide presentation. After review of the slides, an independent observer will ask the patient what they think are the 2 most likely causes of their LBP (in order of likelihood) and match that with the attending physician and trainee, who will independently do the same. The investigative team will then determine how concordant the patient's answers are with the physicians and also record outcomes.

Conditions

Chronic Low Back Pain

Keywords

back pain; education

Outcome Measures

Primary Outcomes (1)

• Concordance

  Concordance (overlap) between the patient's guess at their top 2 diagnoses, and those rendered by the attending physician. The patient's choices include 12 diagnoses (e.g., discogenic pain, spinal stenosis, piriformis syndrome) while the physician's includes 13 (secondary gain).

  Day 0 (enrollment date)

Secondary Outcomes (9)

• Concordance

  Day 0

• Average back pain score

  4 weeks

• Worst back pain score

  4 weeks

• Average leg pain score

  4 weeks

• Worst leg pain score

  4 weeks

Study Arms (2)

Education

EXPERIMENTAL

Educational initiative on back pain

Behavioral: Education

Control

ACTIVE COMPARATOR

Control initiative (non-comprehensive overview)

Behavioral: Control

Interventions

Control BEHAVIORAL

Brief 4-slide presentation without a separate session for questions and answers

Control

Education BEHAVIORAL

Patients will review 28 slides that discuss the different etiologies (causes) of back pain, how common they are, what causes them (e.g., wear and tear, trauma), factors that exacerbate and alleviate the pain, how they are diagnosed and treated, and have an opportunity to ask questions.

Education

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Primary complaint of LBP or sciatica
• Duration of LBP \> 3 months

You may not qualify if:

• Referral for a specific diagnostic procedure or who present with a pre-established diagnosis
• Inability to understand written English

Sponsors & Collaborators

• Northwestern University: lead
• University of Washington: collaborator

Study Sites (2)

Northwestern University Pain Management Center

Chicago, Illinois, 60611, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Lepri B, Romani D, Storari L, Barbari V. Effectiveness of Pain Neuroscience Education in Patients with Chronic Musculoskeletal Pain and Central Sensitization: A Systematic Review. Int J Environ Res Public Health. 2023 Feb 24;20(5):4098. doi: 10.3390/ijerph20054098.

  PMID: 36901108 BACKGROUND

MeSH Terms

Conditions

Back Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will not be privy to the treatment group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research and Pain Medicine, Principal Investigator

Model Details: Patients will be randomized to a comprehensive educational program consisting of 28 slides and answering questions, or a control group (4 brief slides)

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: October 16, 2024
• Primary Completion: May 8, 2026
• Study Completion: May 15, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year from publication
• Access Criteria: Available on request

Locations

US (2)