Goal Oriented Activity for Latinos With Spine Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Low Back Pain, Neck Pain, Chronic Pain, Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: GOALS Intervention
* Behavioral: Usual Care Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOALS Intervention<br>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. | Behavioral: GOALS Intervention<br>* 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.<br>|
| Active Comparator: Usual Care Physical Therapy<br>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. | Behavioral: Usual Care Physical Therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) - Pain Interference | To assess global pain-related disability. Scale values: 0 (min) to 10 (max). Decreases in score indicate improvement in outcomes. | Change from Baseline to Post-Intervention (1-week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) - Pain Interference | To assess global pain-related disability. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes. | Change from Baseline to Post-Intervention (3-month, 6-month) | 
| Brief Pain Inventory (BPI) - Pain Intensity | To assess global pain severity. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes. | Change from Baseline to Post-Intervention (1-week, 3-month, 6-month) | 
| PEG-3 | To assess global pain intensity and pain interference. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes. | Change from Baseline to Post-Intervention (1-week, 3-month, 6-month) | 
| Neck Disability Index (NDI) | 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. | Change from Baseline to Post-Intervention (1-week, 3-month, 6-month) | 
| Modified Oswestry Disability Index (ODI) | 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. | Change from Baseline to Post-Intervention (1-week, 3-month, 6-month) | 
| Patient Specific Functional Scale (PSFS) | To assess ability to perform patient-identified functional activities. Scale values: 0 (min) to 10 (max). Increase in score indicate improvement in outcomes. | Change from Baseline to Post-Intervention (1-week, 3-month, 6-month) | 
| 6-Meter Walk Test | To assess preferred and maximum gait speeds. Scale is measured in seconds. Decrease in score indicate improvement in outcomes. | Change from Baseline to Post-Intervention (1-week) | 
| 30-s Sit-to-Stand | 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. | Change from Baseline to Post-Intervention (1-week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy, rehabilitation, cognitive behavioral, hispanic, health disparities, telehealth