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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Control; Behavioral: Education

Detailed Description

Artificial intelligence (AI), the growth of the internet and internet access, direct-to-patient advertising, and more recently the COVID-19 pandemic with a proliferation of telehealth visits has transformed medicine. Patients come in with a wealth of information, some accurate but some inaccurate, about their condition, often with preconceived notions about what condition they have and how they want to be treated. For conditions such as chronic pain with a high prevalence rate of abnormal imaging findings in asymptomatic individuals, the absence of biomarkers for clear-cut diagnoses, and subjective outcome measures, this has led to unnecessary tests and treatment, doctor shopping, high rates of burnout among providers and low success rates.

The COVID-19 pandemic shed light on accuracy of diagnoses via telehealth, with studies finding a high concordance rate between telehealth visits without the benefit of a physical exam, and in-person pain management consultant, which is similar to that found in other specialties. The proliferation of AI in electronic medical record systems that confer diagnoses based on patient and physician input of symptoms and signs suggests that in the future, patients with access to the information will be able to self-diagnose their chronic pain and other conditions. Many guidelines also recommend education and self-care in their back pain treatment algorithms, though the effect of education on outcomes is not well-known.

With this in mind, the purpose of this study is to determine how accurate patient diagnoses are when they are furnished with readily available information on the different etiologies for chronic low back pain (LBP), the leading cause of disability worldwide.

The plan is to enroll 269 patients in a 3:1 allocation ratio to either the 27-slide educational group or a condensed 4-slide control group. The patient will have the opportunity to ask questions, after which they will rate their top 2 diagnoses, in order. A trainee (resident or fellow) and the attending will do then do the same. Outcomes will be recorded at 4 weeks (e.g., for simple injections such as epidural steroids and sacroiliac joint injections, medications, physical therapy) or at 12 weeks for more invasive procedures such as spinal cord stimulation, radiofrequency ablation, or vertebral augmentation.

Analyses will be performed to: 1) Determine whether the educational program improves the likelihood that the patient correctly self-diagnoses the cause of their back pain using the attending physician as the reference standard compared to the control group; and 2) Whether the educational program improves treatment outcomes.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Pain Management Center
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Age > 18 years

  • Primary complaint of LBP or sciatica
  • Duration of LBP > 3 months

Exclusion Criteria:

• • Referral for a specific diagnostic procedure or who present with a pre-established diagnosis

  • Inability to understand written English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education; Educational initiative on back pain	Behavioral: Education; 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.
Active Comparator: Control; Control initiative (non-comprehensive overview)	Behavioral: Control; Brief 4-slide presentation without a separate session for questions and answers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance	Concordance (overlap) between the patient's guess at their top 2 diagnoses, and those rendered by the trainee. The patient's choices include 12 diagnoses (e.g., discogenic pain, spinal stenosis, piriformis syndrome) while the physician's includes 13 (secondary gain). The intended scale is: Matching patient's and physician's 1st and 2nd diagnoses in order: 6 points; Matching patient' 1st diagnosis to physician's 1st diagnosis but not matching the 2nd diagnosis, or matching 1st and 2nd diagnoses in reverse order (e.g., patient ranks facetogenic 1st and discogenic pain 2nd whereas doctor ranks discogenic and facetogenic pain 1st and 2nd, respectively): 4 points; Patient's 1st diagnosis matches physician's 2nd diagnosis: 3 points; Patient's 2nd diagnosis matches either the physician's 1st or 2nd diagnosis: 2 points; No match on any ranked diagnosis: 0 points	Day 0
Average back pain score	Average back pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)	6 weeks
Worst back pain score	Worst back pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)	6 weeks
Average leg pain score	Average leg pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)	6 weeks
Worst leg pain score	Worst leg pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)	6 weeks
Patient Global Impression of Change (PGIC) scale	7-point Likert scale (7 is best outcome) in which patient rates their improvement as: no change or worse (1); almost the same (2); a little better (3); somewhat better (4); moderately better (5); better (6); a great deal better (7)	6 weeks
Successful outcome	Greater or equal to 30% decrease in average back or leg (for sciatica) pain score coupled with a score >4 out of 7 on the Patient Global Impression of Change (PGIC) scale. For patients with <4 average pain score, we will use "worst" pain score as the baseline reference.	6 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): May 8, 2026
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: back pain; education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: HRP-593/ v11102023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon specific request, with IRB approval
• IPD Sharing Time Frame: 1 year from publication
• IPD Sharing Access Criteria: Available on request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No