ABSTRACT
Background
Chronic low back pain (cLBP) is complex, disabling, and costly to patients and to society. Patients' social circumstances, beliefs, and behaviors interact in a dynamic way with biomedical factors and have the potential to amplify or reduce suffering. It is important to assess the experience of pain via patient‐reported outcomes (PROs). The University of Pittsburgh Mechanistic Research Center, entitled, “Low Back Pain: Biological, Biomechanical, Behavioral Phenotypes (LB 3 P),” is part of the National Institutes of Health's Helping to End Addiction Long‐term Initiative. LB3P conducted a prospective, observational cohort study to identify phenotypes of over 1000 participants with cLBP. This article reports key information from the PROs and selected demographic variables obtained at the in‐person LB3P study enrollment visit.
Methods
The LB3P study participants completed numerous PROs, including the minimum data set assessments of the NIH Research Task Force on back pain and the NIH HEAL Initiative's Common Data Elements. PROs were organized into five conceptual domains: (1) Pain Characteristics and Qualities, (2) Pain‐related Psychosocial Factors, (3) General Psychosocial Factors, (4) General Health and Lifestyle Factors, and (5) Social Determinants of Health (SDoH). Patient Acceptance of Symptom Status, which consists of yes/no responses to 10 questions about whether the level of each of the 10 symptoms is satisfactory, was also assessed.
Results
PRO measures were collected from 1007 LB3P participants with cLBP. The means and standard deviations, or medians and interquartile ranges, and percentages for the PRO variables collected at the in‐person enrollment visit are presented for the overall group and stratified by sex at birth (females and males) and by age (< 60 years old and ≥ 60 years old). For the participants overall, and across sex and age groups, pain intensity and interference were moderate on average. Neuropathic pain, assessed via PainDETECT, was present in 18% of the overall sample, and in 22.5% of those younger than 60. On average, fatigue, depressive and anxiety symptoms, memory and concentration, self‐efficacy, and positive outlook were within normal limits, as indicated by PROMIS T‐scores. However, PROMIS Physical function was below normal, with T‐scores in the mild to moderate range of impairment. When participants were asked to rate the acceptability of their symptom status in 10 areas of function, the most frequently reported areas of dissatisfaction were: pain intensity and interference, physical function, sleep, and fatigue. In the area of SDoH, nearly half (44%) of participants reported having been exposed to traumatic experiences. In the overall group, 36% reported difficulty paying for basic needs such as food, medical care, and heating, while 51% of those in the < 60 group reported this level of financial strain.
Conclusions
The LB3P cLBP observational cohort exhibited moderate levels of pain intensity, pain interference with life activities, and pain‐related disability. Participants reported mild to moderate levels of pain‐related psychosocial factors, and general mental health challenges such as depression and anxiety were relatively rare. Many participants reported a history of exposure to traumatic experiences and having current financial challenges. The LB3P PRO results provide reference values for a community sample of persons with cLBP.
Keywords: behavioral and psychosocial assessment, chronic low back pain, pain characteristics, patient‐reported outcomes, social determinants of health
1. Introduction
Persons who endure chronic low back pain (cLBP) do so in the context of psychosocial and behavioral factors that influence quality of life (QoL) and can amplify or diminish the experience of pain [1]. The biopsychosocial model of pain describes the dynamic interplay among biological, psychological, and social factors that characterize the complex phenomena of chronic pain. Several nonpharmacologic and behavioral back pain treatment trials have specifically addressed psychosocial factors such as pain‐related fears and unhelpful beliefs, often in combination with exercise intervention [2, 3, 4, 5, 6]. The results of the trials vary; perhaps due to the challenges of providing in‐depth assessment in clinical settings. However, the generally positive results support the value of assessing and addressing psychological and psychosocial aspects of the lived experiences of patients with LBP, particularly when the condition is chronic, and point to the need for improved understanding of the overall pain experience.
Existing consensus documents provide guidance on the importance of an expanded understanding of pain, and recommend assessment of behavioral and psychosocial factors in persons experiencing cLBP. The Institute of Medicine's 2011 report, Relieving Pain in America [7], highlights the public health importance of pain and the need for transforming the way pain is perceived, assessed, and treated. The Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT and IMMPACT II [8, 9]) recommended assessment of outcome domains including pain, physical functioning, emotional functioning, improvement ratings, and adverse events. Additional recommendations from IMMPACT [9] included assessment of self‐reported anxiety and depressive symptoms, fear avoidance, pain catastrophizing, sleep, fatigue, neuropathic pain, and other qualities relevant to pain. Following the release of these recommendations, the NIH Pain Consortium convened a Research Task Force (RTF) to develop research standards including a Minimum Dataset (MDS) to be used in cLBP studies. The RTF MDS acknowledged the value of using Patient‐Reported Outcomes Measurement Information System (PROMIS [10]) instruments, which assess a broad variety of health concepts precisely and concisely. The RTF MDS and a related set of Common Data Elements (CDEs) required by the NIH Helping to End Addiction Long‐term (HEAL) Initiative form the core of psychological and pain‐related assessments used in the current study [11].
The University of Pittsburgh's Mechanistic Research Center, entitled, “Low Back Pain: Biological, Biomechanical, Behavioral Phenotypes (LB3P)” is part of the National Institutes of Health's Helping to End Addiction Long‐term (HEAL) Initiative. The overall objective of LB3P is to perform in‐depth phenotyping of patients with cLBP using a multi‐modal assessment approach that can inform improved treatments. The LB3P performed an observational cohort study of over 1000 people with cLBP [12].
This manuscript describes the LB3P patient‐reported outcomes (PROs) and selected demographic variables collected at a single, in‐person enrollment visit. This manuscript is distinctive in that it identifies psychosocial and behavioral characteristics of a large cohort of persons with cLBP, some of whom reported not being engaged in treatment for cLBP. Thus, the sample is more representative of the general population of patients with cLBP than studies of secondary care pain clinic patients or those enrolled in clinical intervention trials for cLBP.
2. Materials and Methods
2.1. Overview
The methods are presented in greater detail in a previous publication [12]. In brief, participants completed a 4.5 h in‐person enrollment visit that included the PRO measures completed electronically, a battery of physical performance tasks, and biospecimen sample collection. LB3P was approved by the University of Pittsburgh's Institutional Review Board.
2.2. Participants
Eligible participants were English‐speaking adults with cLBP, defined as “back pain (in the space between the lower posterior margin of the rib cage and the horizontal gluteal fold) that persisted at least three months and resulted in pain on at least half the days in the past six months.” [13] Participants were excluded if they (1) were not identified in the University of Pittsburgh Medical Center (UPMC) Electronic Health Record (EHR) System, (2) were participating in a masked intervention study for LBP, or (3) had a medical condition that would place the participant at increased risk or preclude them from complying with study procedures.
Participants were enrolled based on referrals from clinicians, research registries, and community announcements between June 2020 and March 2024. The study enrollment visit took place at the University of Pittsburgh Department of Physical Therapy—Clinical and Translational Research Center. Participants were followed remotely for 12 months and were compensated for their participation incrementally at all timepoints. Data presented herein was collected at enrollment.
2.3. Measures
PRO measures in the study included the MDS assessments of the NIH RTF on back pain [13] and the NIH HEAL Initiative's CDEs [14]. Selection of PRO measures was consistent with the BACPAC Biobehavioral Working Group recommendations [11] developed to harmonize assessments across BACPAC and HEAL projects. The LB3P investigators added some assessments specific to the site, including questions about social determinants of health (SDoH), pain behaviors, and perceived social–emotional support.
The PRO measures were organized into five conceptual domains: (1) Pain Characteristics and Qualities, (2) Pain‐related Psychosocial Factors, (3) General Psychosocial Factors, (4) General Health and Lifestyle Factors, and (5) Social Determinants of Health. The following paragraphs list the conceptual domains and specific measures used, along with their response scale ranges and number of items.
2.4. Pain Characteristics and Qualities
Characteristics of pain generally, and LBP specifically, were assessed via several validated self‐report measures. The Pain, Enjoyment, General Activity measure (PEG) [15] is a three‐item questionnaire that assesses pain severity, interference with enjoyment of activities, and interference with general activities over the past week. The questions are rated 0–10, summed, and averaged. Because the PEG does not refer specifically to LBP, we added a 0–10 numeric rating scale (NRS) question about past‐week LBP. PROMIS Pain Intensity [16], also not specific to the low back, is scored on a 0–10 NRS. PROMIS v1.0 Pain Interference 4a is a component of the PROMIS 29 + 2 profile [17, 18, 19, 20, 21, 22, 23] that assesses pain interference with life activities over the past 7 days using four questions rated 1 (Not at all) to 5 (Very much). All PROMIS measures except Pain Intensity (scored 0–10) are reported as T‐scores with a mean of 50 and a standard deviation of 10 and referenced to the general US population or to clinical condition norms [24, 25].
The potential for nociplastic pain or central nervous system (CNS) sensitivity was assessed via the Widespread Pain Index (WPI) [26, 27, 28, 29], which asks about the presence of pain in 19 areas of the body, with scores ranging from 0 to 19, and the Michigan Body Map (MBM) [30], which asks about the presence of pain in up to 35 body locations, 19 of which are 2016 Fibromyalgia criteria pain locations [31]. Neuropathic pain was assessed by the PainDETECT [32] screening questionnaire, which asks eight questions about pain qualities such as burning, tingling, and allodynia (painful sensitivity to touch) and includes a question about the pattern of pain over time. Scores on the PainDETECT can range from −1 (for a trajectory of persistent pain with pain attacks) to 39, with scores ≥ 19 suggesting that a neuropathic component is likely. Perceptions of pain‐related disability were assessed via the Oswestry Disability Index 2.1a (ODI) [33] a 10‐item questionnaire scored from 0% to 100%, with scores ranging from minimal (0%–20% disability) to bed‐bound or exaggerating one's disability related to pain (81%–100% disability). As harmonized in all BACPAC projects, we collected self‐report of the presence of bothersome physical symptoms of stomach pain and headaches.
2.5. Pain‐Related Psychosocial Factors
The six‐item version of the Pain Catastrophizing Scale (PCS) [34, 35, 36], measures the propensity for symptom magnification, feelings of helplessness, and rumination about pain. Items are scored from 0 (Not at all) to 4 (All the time) and summed for a possible range of 0–24. Fear of movement was assessed by the physical activity scale of the Fear Avoidance Beliefs Questionnaire (FABQ) [37], which assesses pain‐related fear of movement and activity in five items that are scored from 0 (Completely disagree) to 6 (Completely agree) for a total score that can range from 0 to 30. The tendency to not ignore or distract oneself from sensations of pain or discomfort was assessed by the Non‐distracting scale of the Multidimensional Assessment of Interoceptive Awareness, version 2 (MAIA‐2) [38], which includes six questions rated 0 (Never) to 5 (Always) for a scale range of 0–30. Pain behaviors, such as pain‐related facial expressions, slow movements, and irritability over the past 7 days, were measured by a four‐item custom version of the PROMIS v2.0 Pain Behavior scale [39]. Items are scored 1 (Never) to 5 (Always) and raw summed scores are converted to T‐scores (Mean 50, SD 10). Acceptance of pain, which includes willingness to engage in one's usual activities despite pain, was assessed by the Chronic Pain Acceptance Questionnaire (CPAQ) [40, 41]; an eight‐item scale with responses from 0 (Never true) to 6 (Always true) with range 0–48. The STarT Back Tool [42] is a screening questionnaire that was developed and validated as a prognostic indicator of risk for chronicity among persons with acute and sub‐acute back pain [43, 44, 45]. The nine items of the STarT Back assess perceived disability (four items) and psychosocial factors (five items) of bothersomeness of pain, anhedonia, and problematic beliefs about pain. Risk is rated as low, medium, or high, with endorsement of psychosocial factors required for scoring moderate and high risk. This measure is frequently used for persons with cLBP despite its original development in those with acute and subacute pain [46].
2.6. General Psychosocial Factors
Several psychological and social factors can both influence and be exacerbated by chronic pain [47, 48]; Depressive symptoms were assessed by the Patient Health Questionnaire two‐item screen (PHQ‐2) [49, 50]; which is one of the HEAL CDEs, and by the PROMIS v1.0 Depression v1.0 4a short form [51, 52]. Each item of the PHQ is scored 0 (never) to 3 (nearly every day) over the past 2 weeks, and a sum score of ≥ 3 indicates the need for further evaluation for depression. PROMIS Depression includes four questions about past 7 days' depressive symptoms, not diagnostic criteria, with each item scored from 1 (Never) to 5 (Always). Anxiety was measured with the PROMIS v1.0 Anxiety 4a [51] that assesses anxiety symptoms over the past 7 days using four items scored from 1 (Never) to 5 (Always), summed, and converted to T‐scores. The Generalized Anxiety Disorder two‐item screener (GAD‐2) [53], is a HEAL CDE that assesses core features of an anxiety disorder such as feeling anxious and being unable to control worry over the past 2 weeks using two questions scored 0 (Not at all) to 3 (Nearly every day) and summed. Stress over the past month was measured by the four‐item version of the Perceived Stress Scale (PSS) [54], which asks about feeling unable to control or overcome difficulties and feeling confident about handling problems. Items of the PSS are scored 0 (Never) to 4 (Very Often) and summed, with scores that can range from 0 to 16. Memory and concentration were assessed via the PROMIS v2.0 Cognitive Function abilities 2a scale [20], which uses a response scale of 1 (Not at all) to 4 (Very much). Social role participation was assessed by the PROMIS v2.0 Ability to Participate in Social Roles and Activities 4a [55], which uses a 1 (Always) to 5 (Never) scale, that can range from 4 to 20 and is converted to a T‐score. Self‐efficacy was assessed by the PROMIS v2.0 General Self‐Efficacy 4a [23, 56]; which asks about perceptions of being able to find solutions to difficulties and is scored from 1 (“I am not at all confident”) to 5 (“I am very confident”), for a score range of 4–20, that is converted to a T‐score. Having an optimistic outlook about oneself and one's future was assessed by the PROMIS v1.0 Positive Outlook 6a short form (SF) [57, 58]; which uses a response scale of 1 (Not at all) to 5 (Very much) and can range from 6 to 30 prior to conversion to a T‐score.
2.7. General Health and Lifestyle Factors
Self‐reported hours per week of Sedentary, Moderate, and Vigorous Physical Activity across occupational (paid or unpaid), household tasks, travel/transport, and recreational/leisure activity were assessed by the World Health Organization (WHO) Global Physical Activity Questionnaire, version 2 (GPAQv2) [59, 60]. Participants are instructed to anchor this activity with small and large increases in breathing or heart rate for estimating moderate and vigorous activity, respectively. Perceptions of overall physical functioning over the past week were assessed by the PROMIS v2.0 Physical Function 6b, which lists various activities and uses a response scale of 1 (Unable to do) to 5 (Without any difficulty). Sleep was assessed by participant report of hours of sleep per night on average, and by the PROMIS v1.0 Sleep Disturbance 6a, which tracks perceptions of sleep quality (rated as 5‐Very poor, to 1‐Very good), unrefreshing sleep, and difficulty falling asleep, which are rated from 5 (Not at all) to 1 (Very much) [61, 62]. Fatigue was assessed with the PROMIS v1.0 Fatigue 4a [16, 63]; which assesses perceptions of feeling run down and having difficulty starting things due to fatigue over the past 7 days, using a response scale of 1 (Not at all) to 5 (Very much). Problematic substance use was assessed by the HEAL CDE‐required TAPS part 1 [64, 65]; which asks about tobacco, alcohol, prescription medication misuse, and substance use over the past year, with response categories of Never, Less than monthly, Monthly, Weekly, and Daily or Almost Daily. Monthly or more frequent tobacco use was considered a positive screen for potential tobacco use disorder. Drinking ≥ 5 (males) or ≥ 4 (females) alcoholic beverages at a time on a monthly or more frequent basis was considered a positive screen for possible alcohol use disorder. Any report of illicit substance use or prescription medication misuse was considered a positive screen for possible substance use disorder. Report of having an opioid medication prescription was also included in the domain of general health and lifestyle factors. Pain medication misuse was assessed via the PROMIS v1.0 Prescription Pain Medication Misuse 7a, which first asks about prescribed pain medications, and if they are used, six questions rate the extent of potential misuse over the past 3 months, using response scales of 1 (Never) to 5 (Almost always) or 1 (Not at all) to 5 (Very much) [66]. Several other indicators of general health and lifestyle factors, such as medical comorbidities and body mass index, are included in the LB3P clinical characteristics manuscript [67].
2.8. Social Determinants of Health
Socio‐environmental factors can be powerful contributors to health and well‐being for persons with chronic pain [68, 69]. Some demographic characteristics, such as reported household income and size, are included in the clinical characteristics manuscript [67]. The LB3P investigators collected additional PRO variables to assess SDoH. Perceptions of having adequate emotional support were assessed with the PROMIS v2.0 Emotional Support 4a [55], which contains four questions about having a supportive person to talk with, scored from 1 (Never) to 5 (Always). Exposure to traumatic or adverse circumstances was assessed using items from the Primary Care Posttraumatic Stress Disorder Screen for the Diagnostic and Statistical Manual for Mental Disorders, fifth edition (PC‐PTSD‐5) [70]. The PC‐PTSD‐5 lists traumatic events such as serious accident, abuse or witnessing an injury or death, and asks whether the respondent has experienced such an event. Questions concerning specific features of PTSD are part of the measure but are not reported here. For participants answering “Yes” on the PC‐PTSD‐5, a question was added regarding whether the trauma exposure occurred during childhood, adulthood, or both. Two questions regarding perceptions of being discriminated against or treated poorly based on race, ethnicity, or color, and based on sexual orientation or gender identity, used response scales from 1 (Never) to 5 (Almost always) and were adapted from published measures [71, 72]. One question was asked to assess financial strain, or difficulty paying for basic needs such as food, medical care, and heating [73] with response categories of 1—Not very hard, 2—Somewhat hard, 3—Hard, and 4—Very hard. Participants could choose to answer, “do not know.”
3. Patient Acceptance of Symptom Status
We assessed overall views about several aspects of physical and psychological functioning by asking a “yes/no” question (e.g., “Do you consider your current level of anxiety to be satisfactory?”) after each PROMIS 29 + 2 profile domain (inclusive of additional BACPAC MDS required questions), and the ODI, for a total count of 10 possible physical, psychosocial, and disability areas with satisfactory levels of symptoms. Although these domains were assessed on continuous scales with validated measures that are useful in research trials and in describing change over time in clinical settings, our intention in asking the patient acceptance of symptom status (PASS) questions was to provide a dichotomous measure of whether the participant considers their symptom level to be acceptable to them or not.
3.1. Data Analysis
Means and standard deviations (SD) were calculated for continuous measures. Where data were highly skewed, medians and interquartile ranges were provided rather than means and SD. Percentages were calculated for categorical variables. These descriptive statistics are provided for the overall sample, as well as stratified by biological sex (females and males), and stratified by age (< 60 and ≥ 60).
4. Results
A total of 1007 individuals (60% female) were enrolled. The average age was 59 ± 17 years. Most participants were non‐Hispanic (90%), White (75%), and 53% attained college or higher education. Fifty‐four percent were married or had a partner, 43% were employed, 38% retired, 41% had an annual household income < $50,000, 20% had been off work for more than 30 days due to LBP, 16% had applied for or received disability, and 6% were on worker's compensation. The majority were obese (average BMI of 31.5 kg/m2), 61% had back pain for > 5 years, and pain had been ongoing every or nearly every day in 76% of the sample [67].
Tables 1, 2, 3, 4, 5 describe means and SDs, or median and IQR, and percentages of the 1007 participants for the PRO variables in each of the five conceptual domains. Table 6 provides descriptive results for the PASS items. Table 7 provides PROMIS symptom severity categories (e.g., within normal limits, mild, moderate, severe) for the overall group. Supporting Information tables reporting PROMIS measures' symptom severity for sex and age categories are included in the Supporting Information. There was a small amount of missing data across some questionnaires (e.g., N = 1003–1007), the ranges of Ns are reported in the tables. One participant reported sex at birth as intersex and was therefore not included in the male/female stratification on the tables.
TABLE 1.
Pain characteristics and qualities patient‐reported outcomes.
| Domain construct | patient‐reported questionnaires | Total (N = 1003–1007) | Female (N = 598–600) | Male (N = 404–406) | Age < 60 (N = 424–427) | Age ≥ 60 (N = 579–580) |
|---|---|---|---|---|---|---|
| Pain characteristics and qualities | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
| Pain intensity/interference | PEG | 5.1 (2.4) | 5.2 (2.4) | 4.9 (2.4) | 5.3 (2.4) | 5.0 (2.4) |
| Pain intensity NRS for low back pain | 5.5 (2.1) | 5.6 (2.1) | 5.2 (2.1) | 5.7 (2.1) | 5.3 (2.1) | |
| PROMIS pain intensity item (Global07) | 5.5 (2.1) | 5.7 (2.0) | 5.1 (2.2) | 5.6 (2.1) | 5.3 (2.1) | |
| PROMIS SF v1.0—pain interference 4a | 60.6 (7.3) | 61.0 (7.2) | 60.1 (7.4) | 60.7 (7.7) | 60.6 (7.0) | |
| Pain locations | Widespread pain index (0–19) | 4.7 (3.1) | 5.0 (3.1) | 4.2 (2.9) | 5.0 (3.3) | 4.5 (2.8) |
| Michigan body map—number of pain sites (0–35) | 7.7 (5.3) | 8.2 (5.4) | 7.0 (5.2) | 8.2 (5.9) | 7.3 (4.9) | |
| Neuropathic pain | PainDETECT | 11.4 (7.6) | 11.8 (7.3) | 10.8 (8.0) | 12.4 (8.2) | 10.6 (7.0) |
| Pain‐related disability | Oswestry disability index | 31.0 (15.3) | 31.7 (15.2) | 30.0 (15.6) | 31.0 (17.0) | 31.1 (14.0) |
| Pain characteristics and qualities | Percent of sample | Percent of sample | Percent of sample | Percent of sample | Percent of sample | |
|---|---|---|---|---|---|---|
| Neuropathic pain | PainDETECT | |||||
| Nociceptive pain components | 60.3% | 58.8% | 62.6% | 54.6% | 64.5% | |
| Neuropathic pain components | 17.8% | 18.2% | 17.2% | 22.5% | 14.3% | |
| Indeterminate pain components | 21.7% | 23.0% | 19.7% | 22.7% | 21.0% | |
| Pain‐related disability | Oswestry Disability Index | |||||
| Minimal (0%–20%) disability | 28.8% | 25.8% | 33.3% | 33.3% | 25.5% | |
| Moderate (21%–40%) disability | 46.6% | 49.2% | 42.6% | 40.3% | 51.2% | |
| Severe (41%–60%) disability | 21.2% | 21.3% | 20.9% | 21.3% | 21.0% | |
| Crippling (61%–80%) disability | 3.1% | 3.3% | 2.7% | 4.4% | 2.1% | |
| Bed‐bound or exaggerating (81%–100%) disability | 0.3% | 0.3% | 0.2% | 0.5% | 0.2% | |
| Pain—somatic symptoms | Bothersome stomach pain | 37.5% | 42.2% | 26.6% | 39.1% | 33.4% |
| Bothersome headaches | 48.2% | 45.7% | 38.4% | 58.8% | 40.3% | |
Note: PROMIS SF results are reported as T‐scores, with mean = 50 and SD = 10.
Abbreviations: NRS, numeric rating scale; PEG, pain, enjoyment, general activities scale; PROMIS, patient reported outcomes measurement information system; SF, short form.
TABLE 2.
Pain‐related psychosocial factors patient‐reported outcomes.
| Domain construct | Patient‐reported questionnaires | Total (N = 1003–1007) | Female (N = 598–600) | Male (N = 404–406) | Age < 60 (N = 424–427) | Age ≥ 60 (N = 579–580) |
|---|---|---|---|---|---|---|
| Pain‐related psychosocial factors | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
| Pain catastrophizing | PCS short form | 9.4 (5.8) | 9.5 (5.9) | 9.1 (5.7) | 10.6 (6.0) | 8.4 (5.6) |
| Fear of movement | FABQ‐physical activity scale | 14.1 (5.7) | 13.7 (5.8) | 14.6 (5.6) | 14.3 (5.8) | 13.9 (5.7) |
| Interoceptive awareness | MAIA‐2 nondistracting subscale | 1.8 (1.0) | 1.7 (1.0) | 1.8 (1.1) | 1.7 (1.1) | 1.8 (1.0) |
| Pain behavior | PROMIS SF v2.0—Pain behavior 4‐item custom short form | 60.4 (4.9) | 60.8 (4.6) | 59.7 (5.2) | 61.2 (5.7) | 59.7 (4.1) |
| Pain acceptance | CPAQ | 27.9 (8.4) | 28.1 (2.2) | 27.7 (8.3) | 27.8 (9.2) | 28.0 (7.7) |
| Pain‐related psychosocial factors | Percent of sample | Percent of sample | Percent of sample | Percent of sample | Percent of sample | |
|---|---|---|---|---|---|---|
| Risk stratification | STarT Back screening tool | |||||
| Low risk | 36.3% | 33.3% | 40.9% | 33.7% | 38.3% | |
| Medium risk | 14.1% | 15.0% | 12.8% | 11.7% | 15.9% | |
| High risk | 48.8% | 51.2% | 45.1% | 53.6% | 45.2% | |
Abbreviations: CPAQ, chronic pain acceptance questionnaire; FABQ, fear avoidance beliefs questionnaire; MAIA‐2, multidimensional assessment of interoceptive awareness‐2; PCS, pain catastrophizing scale; PROMIS SF, patient reported outcomes measurement information system short form.
TABLE 3.
General psychosocial factors patient‐reported outcomes.
| Domain construct | Patient‐reported questionnaires | Total (N = 1003–1007) | Female (N = 598–600) | Male (N = 404–406) | Age < 60 (N = 424–427) | Age ≥ 60 (N = 579–580) |
|---|---|---|---|---|---|---|
| General psychosocial factors | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
| Depression | PHQ2 Depression | 1.2 (1.6) | 1.2 (1.6) | 1.1 (1.5) | 1.6 (1.8) | 0.9 (1.3) |
| PROMIS SF v1.0—Depression 4a | 49.9 (8.6) | 50.6 (8.6) | 48.9 (8.5) | 51.8 (9.4) | 48.5 (7.7) | |
| Anxiety | GAD2 Anxiety | 1.3 (1.7) | 1.4 (1.7) | 1.1 (1.6) | 1.8 (1.8) | 0.9 (1.4) |
| PROMIS SF v1.0—Anxiety 4a | 51.7 (9.1) | 52.2 (9.2) | 50.8 (8.9) | 54.1 (9.1) | 49.9 (8.6) | |
| Social participation | PROMIS SF v2.0—Ability to participate in social roles and activities 4a a | 46.4 (8.7) | 46.4 (8.5) | 46.4 (9.1) | 46.9 (9.2) | 46.0 (8.4) |
| Stress | PSS | 5.6 (3.2) | 5.8 (3.3) | 5.3 (3.2) | 6.7 (3.2) | 4.8 (3.0) |
| Optimistic outlook | PROMIS SF v1.0—Positive outlook 6a a | 52.1 (10.1) | 51.4 (10.3) | 53.2 (9.9) | 50.0 (10.5) | 53.6 (9.6) |
| Memory and concentration | PROMIS SF v2.0—Cognitive function‐abilities 2a a | 50.8 (7.2) | 50.8 (7.1) | 50.8 (7.3) | 49.1 (7.2) | 52.1 (6.9) |
| Self‐efficacy | PROMIS SF v1.0—General self‐efficacy 4a a | 49.7 (9.6) | 48.9 (9.6) | 50.9 (9.5) | 48.8 (10.1) | 50.4 (9.1) |
Abbreviations: GAD2, generalized anxiety disorder screener, 2 item version; PHQ2, patient health questionnaire depression screener, 2 item version; PROMIS, patient reported outcomes measurement information system; PSS, perceived stress scale; SF, short form.
Positively valanced construct (i.e., higher T‐scores are better).
TABLE 4.
General health and lifestyle factors patient‐reported outcomes.
| Domain construct | Patient‐reported questionnaires | Total (N = 1003) | Female (N = 598) | Male (N = 404) | Age < 60 (N = 424) | Age ≥ 60 (N = 579) |
|---|---|---|---|---|---|---|
| General health and lifestyle factors | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | |
| Physical activity | GPAQ | |||||
| Sedentary (hours per wk.) | 38.5 (28.0) | 42.0 (28.0) | 35.0 (28.0) | 42.0 (31.5) | 35.0 (29.2) | |
| Moderate and vigorous activity (hours per wk.) | 8.5 (18.8) | 7.5 (16.0) | 10.0 (22.8) | 8.5 (19.3) | 8.3 (18.3) | |
| Domain construct | Patient‐reported questionnaires | Total (N = 1003–1007) | Female (N = 598–600) | Male (N = 404–406) | Age < 60 (N = 424–427) | Age ≥ 60 (N = 579–580) |
|---|---|---|---|---|---|---|
| General health and lifestyle factors | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
| Physical function | PROMIS SF v2.0—Physical function 6b a | 40.1 (6.1) | 39.8 (6.1) | 40.5 (6.2) | 40.9 (6.6) | 39.5 (5.7) |
| Sleep | Sleep duration (hours) | 6.5 (1.5) | 6.5 (1.5) | 6.5 (1.5) | 6.3 (1.5) | 6.6 (1.4) |
| PROMIS SF v1.0—Sleep disturbance 6a | 53.6 (8.5) | 54.2 (8.5) | 52.7 (8.5) | 55.6 (8.5) | 52.2 (8.3) | |
| Fatigue | PROMIS SF v1.0—Fatigue 4a | 53.8 (9.0) | 54.7 (9.0) | 52.3 (8.9) | 55.1 (9.4) | 52.8 (8.6) |
| Domain construct | Patient‐reported questionnaires | Total (N = 409) | Female (N = 249) | Male (N = 160) | Age < 60 (N = 163) | Age ≥ 60 (N = 246) |
|---|---|---|---|---|---|---|
| General health and lifestyle factors | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |
| Problematic pain medication use | PROMIS SF v1.0—Prescription pain medication misuse 7a (only applicable to respondents receiving prescription pain medication) | 38.9 (4.4) | 38.7 (4.2) | 39.2 (4.7) | 38.8 (4.2) | 38.9 (4.5) |
| Domain construct | Patient‐reported questionnaires | Total (N = 1003–1007) | Female (N = 598–600) | Male (N = 404–406) | Age < 60 (N = 424–427) | Age ≥ 60 (N = 579–580) |
|---|---|---|---|---|---|---|
| General health and lifestyle factors | Percent of sample | Percent of sample | Percent of sample | Percent of sample | Percent of sample | |
| Problematic substance use | TAPS Screener | |||||
| Tobacco (monthly use or more) | 15.3% | 13.5% | 18.0% | 24.3% | 8.6% | |
| Alcohol (monthly or more frequent binging) | 14.1% | 12.8% | 19.5% | 19.9% | 12.2% | |
| Recreational or illicit substance (any use) | 16.7% | 15.5% | 18.5% | 25.3% | 10.3% | |
| Prescription medication (any intentional misuse) | 7.7% | 8.0% | 7.4% | 8.9% | 6.9% | |
| Prescription pain medication | Taking any prescription pain medication (within the past 3 months) | 40.6% | 41.5% | 39.4% | 38.2% | 42.4% |
| Opioid medication | Currently taking a prescribed opioid (daily) | 13.2% | 12.7% | 14.0% | 12.6% | 13.6% |
Abbreviations: GPAQ, general physical activity questionnaire; PROMIS SF, patient reported outcomes measurement information system short form; TAPS, tobacco use, alcohol use, prescription medication misuse, illicit substance use screener.
Positively valanced construct (i.e., higher T‐scores indicate better health).
TABLE 5.
Social determinates of health patient‐reported outcomes.
| Domain construct | Patient‐reported questionnaires | Total (N = 1003–1007) | Female (N = 598–600) | Male (N= 404–406) | Age < 60 (N = 424–427) | Age ≥ 60 (N = 579–580) |
|---|---|---|---|---|---|---|
| Social determinants of health | Percent of sample | Percent of sample | Percent of sample | Percent of sample | Percent of sample | |
| Trauma exposure | Does not report exposure to traumatic event(s) | 56.4% | 55.0% | 58.6% | 47.8% | 62.8% |
| Exposure to traumatic event(s) as a child | 20.4% | 23.2% | 16.3% | 29.5% | 13.6% | |
| Exposure to traumatic event(s) as an adult | 36.4% | 36.5% | 36.2% | 42.4% | 32.1% | |
| Exposure to traumatic event(s) as a child and adult | 13.3% | 14.7% | 11.3% | 19.9% | 8.4% | |
| Perceived discrimination | Perceptions of unfair treatment due race/ethnicity | 37.2% | 36.3% | 39.8% | 42.6% | 33.3% |
| Perceptions of unfair treatment due to sexual orientation or gender identity | 14.0% | 16.0% | 11.3% | 23.2% | 7.2% | |
| Financial strain | Perceived difficulty paying for basic needs | 36.4% | 39.5% | 30.0% | 50.7% | 26.0% |
| Emotional support | PROMIS SF v2.0—Emotional support 4a a | 53.5 (8.7) | 53.4 (8.7) | 53.5 (8.7) | 52.8 (9.0) | 54.0 (8.4) |
Note: Trauma exposure assessed via the PC‐PTSD‐5, primary care post‐traumatic stress disorder screener for DSM‐5.
Positively valanced construct (i.e., higher T‐scores are better).
TABLE 6.
Patient acceptance of symptom status.
| Domain construct | Patient‐reported questionnaires | Total (N = 1007) | Female (N = 600) | Male (N = 406) | Age < 60 (N = 427) | Age ≥ 60 (N = 580) |
|---|---|---|---|---|---|---|
| Satisfied with level of functioning/symptoms… | Percent satisfied | Percent satisfied | Percent satisfied | Percent satisfied | Percent satisfied | |
| Pain intensity | PROMIS pain intensity item (Global07) | 29.1% | 27.5% | 31.5% | 31.4% | 27.4% |
| Physical functioning | PROMIS SF v2.0—Physical function 6b | 35.1% | 34.3% | 36.2% | 38.6% | 32.4% |
| Pain interference | PROMIS SF v1.0—Pain interference 4a | 35.2% | 32.0% | 39.9% | 34.9% | 35.3% |
| Back pain disability | ODI—Satisfied with ability to manage everyday life due to back pain | 43.3% | 42.3% | 44.8% | 44.0% | 42.8% |
| Fatigue | PROMIS SF v1.0—Fatigue 4a | 44.6% | 39.8% | 51.7% | 40.3% | 47.8% |
| Sleep disturbance | PROMIS SF v1.0—Sleep disturbance 6a | 44.6% | 40.8% | 50.2% | 39.1% | 48.6% |
| Social participation | PROMIS SF v2.0—Ability to participate in social roles and activities 4a | 51.4% | 51.5% | 51.5% | 52.0% | 51.0% |
| Anxiety | PROMIS SF v1.0—Anxiety 4a | 76.0% | 74.8% | 77.8% | 66.3% | 83.1% |
| Depression | PROMIS SF v1.0—Depression 4a | 78.1% | 76.8% | 80.0% | 70.2% | 83.4% |
| Memory and Concentration | PROMIS SF v2.0—Cognitive function‐abilities 2a | 78.6% | 79.0% | 78.1% | 73.3% | 82.6% |
TABLE 7.
PROMIS categories in overall sample.
| Domain construct | PROMIS questionnaires | Total (N = 1003–1007) | |||
|---|---|---|---|---|---|
| Within normal limit (T‐score: 0 to < 55) | Mild impairment (T‐score: 55 to < 60) | Moderate impairment (T‐score: 60 to < 70) | Severe impairment (T‐score: 70–100) | ||
| Depression | PROMIS SF v1.0—Depression 4a | 69.8% | 16.3% | 12.5% | 1.4% |
| Anxiety | PROMIS SF v1.0—Anxiety 4a | 60.7% | 22.1% | 14.6% | 2.6% |
| Sleep | PROMIS SF v1.0—Sleep disturbance 6a | 57.7% | 22.2% | 16.1% | 4.0% |
| Fatigue | PROMIS SF v1.0—Fatigue 4a | 52.9% | 21.7% | 21.4% | 4.0% |
| Pain interference | PROMIS SF v1.0—Pain interference 4a | 19.1% | 29.1% | 43.2% | 8.6% |
| Pain behavior | PROMIS SF v2.0—Pain behavior 4‐item custom short form | 9.1% | 32.9% | 54.6% | 3.4% |
| Severe impairment (T‐score: 0 to < 30) | Moderate impairment (T‐score: 30 to < 40) | Mild impairment (T‐score: 40 to < 45) | Within normal limit (T‐score: 45–100) | ||
|---|---|---|---|---|---|
| Social participation | PROMIS SF v2.0—Ability to participate in social roles and activities 4a | 3.6% | 19.4% | 27.6% | 49.5% |
| Memory and concentration | PROMIS SF v2.0—Cognitive function‐abilities 2a | 1.4% | 5.0% | 17.3% | 76.4% |
| Physical function | PROMIS SF v2.0—Physical function 6b | 2.7% | 48.0% | 27.3% | 22.0% |
| Very low (T‐score: 0 to < 30) | Low (T‐score: 30 to < 40) | Average (T‐score: 40 to < 60) | High (T‐score: 60 to < 70) | ||
|---|---|---|---|---|---|
| Optimistic outlook | PROMIS SF v1.0—Positive outlook 6a | 1.7% | 8.1% | 67.5% | 22.5% |
| Self‐efficacy | PROMIS SF v1.0—General self‐efficacy 4a | 1.5% | 17.1% | 63.7% | 17.7% |
| Emotional support | PROMIS SF v2.0—Emotional support 4a | 0.7% | 5.9% | 50.0% | 43.3% |
Note: Cut‐point categories are based on PROMIS T‐scores, which are referenced to the US general population or to clinical samples and have mean = 50 and SD = 10. For PROMIS measures in which higher T‐scores indicate worse health, such as depression, anxiety, sleep disturbance, T‐scores from 0.5 to 1 SD above 50 indicate mild problems; 1–2 SD above 50 indicate moderate problems; and 2 or more SD above 50 indicate severe problems. For PROMIS measures in which higher T‐scores indicate better health or functioning (e.g., social roles, physical function), T‐scores 0.5–1 SD below 50 indicate mild problems; 1–2 SD below 50 indicate moderate problems; and 2 or more SD below 50 indicate severe problems. PROMIS cut‐point categories for measures of perceived well‐being (e.g., self‐efficacy) range from very low to high. https://www.healthmeasures.net/score‐and‐interpret/interpret‐scores/promis/promis‐score‐cut‐points.
4.1. Pain Characteristics and Qualities
Pain intensity, assessed via LBP NRS and PROMIS Pain Intensity, was rated as moderate on average across all participants (mean 5.5, SD 2.1) (Table 1). The PEG, which combines pain intensity and interference, was also moderate on average among the LB3P participants. PROMIS Pain Interference was in the moderate range on average; however, 8.6% reported severe pain interference. On average, participants reported moderate disability on the ODI; however, 21.2% reported severe disability and 3.1% reported 61%–80% disability, described by the ODI as “crippling disability” Pain locations identified on WPI and Michigan Body Map indicated a relatively small number of non‐LBP locations, on average. The average PainDETECT score was 11.4 (SD 7.6), and 17.8% scored ≥ 19, the score indicative of likely neuropathic components of pain [32]. Bothersome stomach pain was reported by 37.5% of the sample overall, with 42.2% of women and 26.6% of men reporting stomach pain. Bothersome headaches were reported by 48.2% of the sample; descriptively, greater proportions of women and younger participants reported this symptom.
4.2. Pain‐Related Psychosocial Factors
Participants reported minor to moderate levels of problematic pain‐related psychological factors (Table 2). Pain catastrophizing was present at modest levels, with a mean score of 9.4 (SD 5.8) in a 0–24 range. The FABQ‐Physical Activity scale, which assesses beliefs that physical activity will increase one's pain, also had modest scores on average. In contrast, participants reported moderate levels of pain behaviors. Being willing to engage in activities despite pain was also moderate on average. Participants endorsed a low level of ignoring or distracting from pain on the MAIA‐2 Not‐Distracting scale. On the STarT Back screen, which combines problematic psychosocial factors with disability perceptions to yield a risk score for chronicity, approximately half of participants were high risk. However, contrary to what one might expect in a cLBP sample, approximately one third were categorized as low risk.
4.3. General Psychosocial Factors
On average, participants did not exhibit problematic depression or anxiety symptoms or a high degree of perceived stress (Table 3). PROMIS T‐scores were on average normal, with all measures close to the population mean of 50. However, approximately 14% of participants reported moderate to severe depressive symptoms; approximately 17% reported moderate to severe anxiety symptoms. PROMIS Ability to Participate in Social Roles and Activities was normal on average, and 22.9% of participants scored in the moderate to severe ranges of impairment on this measure.
4.4. General Health and Lifestyle Factors
Participants reported the amount of time each week that they engaged in moderate and vigorous physical activity during work, household tasks, and recreation on the GPAQ, as well as estimating sedentary time (Table 4). Overall, the median combined moderate/vigorous activity was 8.5 h per week (IQR 18.8) whereas sedentary time was a median of 38.5 (IQR 28) hours per week. Mild to moderate problems were reported on PROMIS Physical Function on average. However, 48% of participants reported moderate impairment, and 2.7% reported severe impairment in this area. While hours of sleep averaged 6.5 h per night, normal ratings on PROMIS Sleep Disturbance were reported for all except those aged 60 and under, who reported mild sleep problems on average. Approximately 20% of the overall sample reported moderate to severe sleep disturbance. Fatigue levels were within the normal range on average for all groups except those under 60 years old, who reported mild problems with fatigue on average. Moderate to severe fatigue was reported by 25.4% of participants.
Approximately 40% of the sample reported taking prescription pain medications. For those individuals, misuse of pain medications was rare, with PROMIS Prescription Pain Medication Misuse averaging well below the population mean T‐score of 50. Current opioid use was reported by 13.2%; intentional prescription medication misuse was reported by only 7.7% of participants on the TAPS1 screen.
4.5. Social Determinants of Health
Exposure to traumatic events was reported by approximately 40% of participants, and perceptions of being treated unfairly or discriminated against due to race, ethnicity, or color were reported by over one‐third of participants, with over 42% of those under 60 years old reporting this experience (Table 5). While perceptions of being treated unfairly due to sexual orientation or gender identity were reported by 14% of the overall sample, about 23.2% of those under 60 reported this experience. In the overall sample, 36.4% endorsed somewhat or greater difficulty paying for basic needs such as food, medical care, and heat; in the under 60 age group, this was reported by 50.7% of the sample. On average, perception about receiving emotional and social support from others was within normal limits, and PROMIS T‐scores for the majority of participants indicated average or high levels of emotional/social support (Table 7).
4.6. Patient Acceptance of Symptom Status
The most frequently reported areas of dissatisfaction were pain intensity and interference, physical function, back pain disability, sleep, and fatigue (Table 6). To capture participants' overall satisfaction/dissatisfaction with their levels of symptoms, we summed the potential physical and psychosocial PASS results. On average, participants expressed acceptance or satisfaction with 5.2 out of 10 possible areas.
5. Discussion
Although the participants were all patients in a large academic health system, they were not required to be receiving treatment specifically for their back pain to be enrolled in the current study. The results from this cohort of participants are representative of a community sample of persons who are living with cLBP.
In our cohort, pain intensity was moderate and pain interference with life activity and enjoyment was rated as mild to moderate on average. Participants' depression and anxiety symptoms were low on average, as were pain‐related psychosocial factors of catastrophizing, fear avoidance beliefs, and perceived stress. While participants reported moderate levels of perceived disability and mild problems with participating in social roles and activities, their sleep and levels of fatigue were not reported to be problematic on average. Prescriptions for opioid pain medications were relatively low in this group. The proportion of the cohort taking any pain medications was 40%; with few of these persons reporting misuse. In summary, although pain influenced social and physical functioning, psychosocial and psychiatric difficulties were relatively modest in this group overall.
The LB3P cohort results provide a set of PRO norms for females and males, and younger and older persons, living with cLBP who may or may not be engaged in pain treatment. This study's results differ from others that provide PRO norms for clinical samples in which patient data is collected as part of primary care or specialty pain centers. For example, compared to this study, pain catastrophizing scores were higher in a cohort of over 12 000 patients in pain clinics in Australia and New Zealand [74], and in a sample of 280 cLBP patients engaged in an interdisciplinary chronic pain program [36]. The LB3P cohort average score on PCS was lower than the chronic pain program's pre‐treatment values and was similar to the program's post treatment values. Researchers, clinicians, and policy leaders may benefit from having access to a set of PRO norms for a broader range of people living with cLBP than is typically provided in the cLBP literature.
An unexpected finding was that approximately one‐third of participants scored in the “Low Ris” category on the STarT Back screening tool. Typically, this tool is used as a prognostic indicator for acute or sub‐acute LBP to become chronic, and it was designed to be administered in the early phases of the condition. All LB3P participants met criteria for cLBP, so the fact that one third scored as low risk for cLBP using the screening tool is surprising. Endorsing psychosocial symptoms such as fear‐avoidance, depressive symptoms, or expecting the worst are required for categorization as moderate or high risk for chronicity when assessed in acute and subacute phases. Although some LB3P participants reported problematic levels of these pain‐related psychosocial factors, many did not, which may explain the large number of individuals in the low‐risk category.
Strengths of this cLBP observational study include the large size of the cohort and the breadth of PROs assessed. Despite the aspiration to comprehensively assess participants' experiences through PROs, we recognized the need to minimize participant burden, as this project included many other tasks in addition to the completion of PROs. To mitigate the burden of questionnaires, we chose, wherever possible, to administer validated brief versions of PROs. This may have resulted in reduced measurement precision. However, there is evidence that brief measures such as the PEG are both feasible and valid for assessing response to pain treatments, particularly if a 1‐week response time is used [75]. A potential limitation is the use of some measures that were adapted from other measures or were developed for this project. For example, existing SDoH measures were developed after this study's inception and are lengthy. Although measuring financial strain, trauma exposure, and perceived discrimination were priorities for the team of researchers, we made the decision to create brief or single‐item assessments to balance comprehensive coverage with feasibility. The participant compensation, which was generous for full‐study completion, may be considered both a strength and a limitation. Honoring participants' time and energy throughout the study through payments and personal contact with staff encouraged participants to enroll and carry out the various study activities. On the other hand, some participants may have been motivated to enroll for financial reasons alone rather than to contribute to improved understanding of cLBP.
In conclusion, the LB3P enrollment visit PROs describe a cLBP group with moderate levels of pain intensity, pain interference, and disability, mild to moderate pain‐related psychosocial factors, and minimal mental health challenges. Although many of the participants reported having been exposed to traumatic events, the group overall reported average to high levels of general self‐efficacy and receiving emotional support from others. The LB3P cohort PROs data provide norms for a broad range of PROs in a general community sample of persons with cLBP.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: Supporting Information.
Data S2: Supporting Information.
Acknowledgments
The Back Pain Consortium Research Program is administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This research was supported by the National Institutes of Health through the NIH HEAL Initiative under award number U19AR076725‐01. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health, the National Cancer Institute, or the NIH HEAL Initiative. The authors would like to thank Selena Crawford, LB3P's project manager, and the members of our advisory board—Dino Samartzis, James Iatridis, Kevin Luster, Nicole Kelly, and Ronald Glick.
Greco C. M., Dodds N. E., Acevedo A. M., et al., “Patient‐Reported Outcomes Among an Observational Cohort of Individuals With Chronic Low Back Pain,” JOR Spine 8, no. 3 (2025): e70097, 10.1002/jsp2.70097.
Funding: This work was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, U19AR076725‐01.
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Supplementary Materials
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