Goal Oriented Activity for Latinos With Spine Pain (GOALS)

Efficacy of a Culturally Adapted Cognitive Behavioral Based Physical Therapy Intervention for Latinos With Chronic Spine Pain

National Institute on Minority Health and Health Disparities (NIMHD), Family Health Centers of San Diego

The primary purpose of the study is to determine the efficacy of a culturally adapted cognitive behavioral based tele-rehabilitation program compared to usual care for Hispanics/Latinos with chronic neck or low back pain. Goal Oriented Activity for Latinos with Spine Pain (GOALS) is an evidence-based cognitive behavioral physical therapy program that has been adapted for Hispanics/Latinos with chronic spine pain. GOALS combines 2 in-person evaluation sessions with 6 telephone treatment sessions provided once a week for 8 weeks by a physical therapist trained in cognitive behavioral approaches for pain management. Usual Care involves 8 weeks of in-person treatment as recommended by a physical therapist at a Federally Qualified Health Center (FQHC) outpatient rehabilitation clinic. The primary outcome that will be evaluated is pain-related disability as measured by the Brief Pain Inventory Pain Interference scale. It is hypothesized that participants in the GOALS intervention will experience a greater improvement in pain-related disability than participants in the Usual Care group.

138 Hispanics/Latinos with chronic spine pain will be identified through consecutive sampling of patients at a local FQHC who were referred by their primary care physician to physical therapy (PT) for neck or low back pain. Participants who are deemed eligible and enroll in the study will be scheduled for the first study assessment, where they will provide written informed consent for participation. Participation includes 4 study assessments and 8-weeks of treatment with either GOALS or Usual Care PT. Participants will be stratified by sex (male/female) and diagnosis (low back pain/neck pain) and randomized into either the GOALS or the Usual Care group following completion of the Baseline assessment. Study assessments will be conducted 1-week before (Baseline) and 1-week (Post), 3-months (3-mo Post), and 6-months (6-mo Post) after completing 8 weeks of GOALS or Usual Care PT. The primary aim of the study is to determine the efficacy of a culturally adapted cognitive behavioral based PT tele-rehabilitation program compared to usual care in Hispanics/Latinos with chronic spine pain, based on improvement in the pain interference scale in the Brief Pain Inventory after treatment (primary outcome). The 1-week post-intervention assessment will be analyzed using a linear regression model. The time by condition (GOALS vs. Usual Care) interaction term will be added to the models to assess for intervention effects. If the interaction is not significant, the main effect for time and condition will be assessed. For all outcomes, the models will be adjusted for sociodemographic and clinical characteristics that may affect treatment response. Secondary outcomes of pain interference at other time-points (3- and 6-mo Post) and patient reported outcomes and physical performance measures at all time points will be evaluated in the same manner. It is hypothesize that participation in the GOALS intervention compared to Usual Care will result in greater improvements in pain interference (primary outcome), as well as secondary patient reported outcomes and physical performance measures. Pre-planned secondary analyses will explore biological/physical, psychological, and environmental moderators and mediators of treatment response. The dependent variable for this analysis will be treatment response, whereby participants will be dichotomized into responder and non-responder groups based on a ≥30% reduction in pain interference as recommended by IMMPACT guidelines. An exploratory, backward selection approach using separate multivariate logistic regression models will be used to identify predictors that are most strongly related to treatment response. These variables will then be entered into a single combined multivariate logistic regression model adjusted for sociodemographic covariates of treatment response. The study will also explore potential mediators of treatment response with structural equation modeling (SEM) using maximum likelihood estimation methods. Parameter estimates will be evaluated and indirect effects, reflecting mediation, will be calculated and examined for statistical significance and clinical meaningfulness. It is hypothesized that baseline indicators for high fear of movement and sedentary behavior will predict a positive response to the GOALS intervention. However, the study will also collect and analyze other candidate predictors of treatment response based on a conceptual model of the pain experience in Hispanics/Latinos.

The primary purpose of this interventional study is to determine the efficacy of a culturally adapted cognitive behavioral based tele-rehabilitation program compared to usual care for Hispanics/Latinos with chronic neck or low back pain. The main objective of the GOALS intervention is to improve pain-related disability in Hispanics/Latinos with chronic spine pain. The interventional study model is a single site, 2-arm parallel assignment randomized clinical trial with blinded assessors. After completing the baseline assessment, enrolled participants will be stratified by sex (male, female) and diagnosis (low back pain/neck pain) and randomized into either the GOALS intervention arm or the Usual Care control arm.

Research assistants conducting all assessments and biostatisticians conducting the analyses will be masked to treatment group. Participants, physical therapist providers, investigators, recruitment coordinators, and project managers will not be masked. Physical therapists who provide the Usual Care intervention will be naïve to the purpose of the study and details of the GOALS intervention.

The experimental arm is an 8-week cognitive-behavioral based physical therapy (PT) intervention for chronic spine pain. The manualized intervention utilizes a hybrid tele-rehabilitation delivery model. GOALS comprises an initial in-person evaluation (60 min) by a research physical therapist, followed by 6 remote treatment sessions (30-45 min each) conducted by the same physical therapist once a week by telephone. A second in-person evaluation is conducted at the midpoint of the GOALS intervention to assess progress and advance the participant's home exercise program.

The control arm is Usual Care physical therapy (PT) at a local Federally Qualified Health Center (FQHC), which offers PT services at 4 outpatient clinics across San Diego county. Participants in the Usual Care group attend an initial PT evaluation at a FQHC Physical Rehabilitation Clinic. The frequency and type of PT intervention are then determined by the treating physical therapist in accordance with standard clinical practice at the FQHC.

Weekly treatment sessions are comprised of a graded activity program focused on goal setting in 4 treatment domains: therapeutic exercise, aerobic activity, functional activity, and pain coping skills. Instruction in cognitive behavioral coping skills for pain include: explaining pain (pain neuroscience education), pacing, soliciting positive social support, cognitive restructuring, present mindedness, and symptom self-management planning.

Usual care will be characterized by extracting the following variables from participants' electronic health record: date of physician referral to physical therapy for neck or low back pain diagnosis (index referral), attendance of at least one PT visit (adherence), dates of first and last PT visits for index referral (duration of care), number of PT visits attended across an 8-week episode of care for the index referral (number of visits), clinic where PT services were provided (service location), and CPT billing codes issued during the episode of care for the index referral (type and frequency of treatments provided).

To assess global pain-related disability. Scale values: 0 (min) to 10 (max). Decreases in score indicate improvement in outcomes.

To assess global pain-related disability. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.

To assess global pain severity. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.

To assess global pain intensity and pain interference. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.

To assess regional pain-related disability for people with neck pain. Scale values: 0% (min) to 100% (max). Decrease in score indicate improvement in outcomes.

To assess regional pain-related disability for people with low back pain. Scale values: 0% (min) too 100% (max). Decrease in score indicate improvement in outcomes.

To assess ability to perform patient-identified functional activities. Scale values: 0 (min) to 10 (max). Increase in score indicate improvement in outcomes.

To assess preferred and maximum gait speeds. Scale is measured in seconds. Decrease in score indicate improvement in outcomes.

To assess number of repetitions for a sit-to-stand functional performance task for people with low back pain. Scale is measured in number of repetitions. Increase in score indicates improvement in outcomes.

To assess participant expectancy related to treatment condition assigned. Scale values: 0 (min) to 10 (max). Higher scores indicate better therapeutic alliance.

To assess therapeutic alliance for the treatment condition rendered. Scale values: 16 (min) to 64 (max). Higher scores indicate better therapeutic alliance.

To assess self-reported improvement with intervention. Scale values: 1 (min) to 7 (max). Lower scores indicate better outcomes.

To assess self-reported satisfaction with intervention. Scale values: 1 (min) to 7 (max). Lower scores indicate better outcomes.

To assess fear of movement associated with neck or low back pain. Physical activity subscale: Scale values: 0 (min) to 24 (max). Work Subscale: Scale values: 0 (min) to 42 (max). Decrease in scores indicate improvement in outcomes.

To assess pain catastrophizing. Scale values: 0 (min) to 52 (max). Decrease in scores indicate improvement in outcomes.

To assess social support. Scale values: 0% (min) to 100% (max). Increase in scores indicate improvement in outcomes.

To assess general self-efficacy. Scale values: 1 (min) to 5 (max). Increase in scores indicate an improvement in outcomes.

To assess self-efficacy specifically related to pain. Scale values: 0 (min) to 60 (max). Increase in scores indicate improvement in outcomes.

To assess generalized anxiety. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.

To assess depressive symptoms. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.

To assess sleep disturbance. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.

To assess generalized physical function. Scale values: 0 (min) to 100 (max). Increase in scores indicate improvement in outcomes.

To assess participation in social roles and activities. Scale values: 0 (min) to 100 (max). Increase in scores indicate improvement in outcomes.

To assess self-reported physical activity. Aerobic scale values: 1 (min) to 7 (max). Increase in scores indicate improvement in outcomes.

To assess self-reported physical activity. Strength & Flexibility scale values: 0 (min) to 3 (max). Increase in scores indicate improvement in outcomes.

To assess self-efficacy specifically related to exercise. Scale values: 1 (min) to 5 (max). Increase in scores indicate improvement in outcomes.

Objective measure of physical activity. Physical activity scale values: 0% (min) to 100% (max) (increase in score indicate improvement in outcomes.)

Objective measures of physical activity. Sedentary behavior scale values: 0% (min) to 100% (max) (decrease in score indicate improvement in outcomes.)

To assess spine posture and movement and associated pain behavior during clinical tests and daily activities.

To assess the extent to which participants attain weekly goals in the GOALS intervention. Scale values: -2 (min) to 2 (max). Higher scores indicate greater adherence to weekly goals.

To assess the extent to which participants are continuing to utilize the GOALS/Metas program activities and the importance of the physical therapy treatment in management of their chronic spine pain.

Inclusion Criteria: Referred to physical therapy by primary care physician 18-66 years old Hispanic Diagnosis of chronic neck or low back pain Must attend at least 1 physical therapy treatment session Exclusion Criteria: Tumor, infection, or other major medical problem affecting the neck or low back Health problems that severely affect ability to move, walk one block, or participate in exercise Presence of external incentives for non-recovery (e.g., litigation, worker's compensation benefits) Initiating or receiving any new psychotherapy or behavioral health treatment for the neck or low back pain during the observation period Diagnosis of a major psychological condition (e.g., schizophrenia, psychosis, bipolar disorder) Inability to provide a stable address with access to a telephone or any other reason that would preclude participation in a telephone-based intervention Cohabitating with a GOALS/Metas participant Pregnant or lactating

Individual participant data (including data dictionaries) that underlie the results reported in publications, after deidentification (text, tables, figures, appendices), will be available. Other documents that will be made available include: Study Protocol, Statistical Analysis Plan, Analytic Code, Informed Consent Form, Patient Guide (English/Spanish), and Therapist Guide (English/Spanish). Data will be available for individual participant data meta-analysis beginning 6 months and ending 5 years following article publication.

Data will be available to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose by the San Diego State University HealthLINK Advisory Board. To gain access, data requestors will need to sign a data access agreement. Proposals should be directed to sgombatto@sdsu.edu. Data are available for 5 years through the San Diego State University HealthLINK Health Science Knowledge Repository website.

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