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Chronic Low Back PainNCT06630676

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

A study testing Education in people with Chronic Low Back Pain, run by Northwestern University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigative team will provide 27 (28 with title) 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
2 sitesUnited States
Study dates
16 Oct 2024to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern University Pain Management Center

    Chicago, Illinois, 60611

  • University of Washington

    Seattle, Washington, 98105

Other trials in United States

About this study

The investigative team will provide 27 (28 with title) 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.

Read the 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 284 patients in a 3:1 allocation ratio to either the 28-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 6 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.

Being tested
Control, Education
Keywords
back pain, education
Medical subject headings
Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ControlBehavioural

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

  • EducationBehavioural

    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.

Study groups in NCT06630676
Study groupRoleWhat they receive
EducationExperimentalEducational initiative on back pain
Receives: Behavioral: Education
ControlActive comparatorControl initiative (non-comprehensive overview)
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Day 0 (enrollment date)

Secondary outcomes (7)

  1. 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

    Measured: Day 0

  2. Average back pain score

    Average back pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)

    Measured: 6 weeks

  3. Worst back pain score

    Worst back pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)

    Measured: 6 weeks

  4. Average leg pain score

    Average leg pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)

    Measured: 6 weeks

  5. Worst leg pain score

    Worst leg pain score over past week on a 0-10 numerical rating scale (higher scores indicating greater pain)

    Measured: 6 weeks

  6. 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)

    Measured: 6 weeks

  7. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start16 Oct 2024
  3. Primary completion8 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to a comprehensive educational program consisting of 28 slides and answering questions, or a control group (4 brief slides)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630676
Sponsor's protocol ID
HRP-593/ v11102023
Status last verified
Oct 2026
First submitted
2 Oct 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon specific request, with IRB approval

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.

    PubMed 36901108

Questions about this trial

What is this clinical trial studying?

A study testing Education in people with Chronic Low Back Pain, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance (time frame: Day 0 (enrollment date)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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