Clinical trial NCT05005416: Goal Oriented Activity for Latinos With Spine Pain
Official title: Efficacy of a Culturally Adapted Cognitive Behavioral Based Physical Therapy Intervention for Latinos With Chronic Spine Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Neck Pain
Chronic Pain
Chronic Low-back Pain
Keywords: physical therapy
rehabilitation
cognitive behavioral
hispanic
health disparities
telehealth
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Family Health Centers of San Diego
First posted: 2021-08-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 123 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 projected sample size for GOALS changed from N=138 to N=123 after adding an eligibility criterion requiring participants to attend the PT evaluation. Our power analysis indicated N=98 participants is the smallest sample size needed to detect the effect of the GOALS intervention. Before beginning the trial, we estimated a 41% attrition rate given data from the partnering clinic, suggesting we needed to recruit N=138 to meet our N=98 sample size. However, we added an inclusion criterion that participants need to attend the initial PT evaluation in order to be enrolled in the study. We retained an estimated attrition rate of 20% of enrolled participants, requiring an initial sample size of N=123 to meet the N=98 minimum sample size.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Pain Inventory (BPI) - Pain Interference
timeFrame: Change from Baseline to Post-Intervention (1-week)
Secondary outcomes:
measure: Brief Pain Inventory (BPI) - Pain Interference
timeFrame: Change from Baseline to Post-Intervention (3-month, 6-month)
measure: Brief Pain Inventory (BPI) - Pain Intensity
timeFrame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
measure: PEG-3
timeFrame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
measure: Neck Disability Index (NDI)
timeFrame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
measure: Modified Oswestry Disability Index (ODI)
timeFrame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
measure: 6-Meter Walk Test
timeFrame: Change from Baseline to Post-Intervention (1-week)
measure: 30-s Sit-to-Stand
timeFrame: Change from Baseline to Post-Intervention (1-week)
Other outcomes:
measure: Treatment Expectancy Measure
timeFrame: Baseline
measure: Kim Alliance Scale (KAS)
timeFrame: Post-Intervention (1-week)
measure: Global Impression of Change (GIC)
timeFrame: Post-Intervention (1-week, 3-month, 6-month)
measure: Global Rating of Satisfaction (GRS)
timeFrame: Post-Intervention (1-week, 3-month, 6-month)
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline; Post Intervention (1-week, 3-month)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: Medical Outcomes Study - Social Support Measure (MOS-SS)
timeFrame: Baseline; Post-Intervention (1-week)
measure: New General Self-Efficacy Scale (GSES)
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: PROMIS Short-Form Anxiety 4a
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: PROMIS Short-Form Depression 4a
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: PROMIS Short-Form Sleep Disturbance
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: PROMIS Short-Form Physical Function 4a
timeFrame: Baseline, Post-Intervention (1-week, 3-month)
measure: PROMIS Short-Form Ability to Participate 4a
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: Rapid Assessment of Physical Activity (RAPA) Aerobic
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: Rapid Assessment of Physical Activity (RAPA) Strength and Flexibility
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: Self-Efficacy and Exercise Habits Survey (SEHS)
timeFrame: Baseline; Post-Intervention (1-week, 3-month)
measure: Physical Activity (Actigraph)
timeFrame: Baseline; Post-Intervention (1-week)
measure: Physical Activity and Sedentary Behavior (Actigraph)
timeFrame: Baseline; Post-Intervention (1-week)
measure: Sleep Efficiency (Actigraph)
timeFrame: Baseline; Post-Intervention (1-week)
measure: Sleep Duration (Actigraph)
timeFrame: Baseline; Post-Intervention (1-week)
measure: Sleep Onset (Actigraph)
timeFrame: Baseline; Post-Intervention (1-week)
measure: Posture and Movement Measures (DorsaVi)
timeFrame: Baseline; Post-Intervention (1-week)
measure: Goal Attainment Scale
timeFrame: Once weekly during 8-week GOALS intervention
measure: Adverse Event Checklist
timeFrame: Once weekly during 8-week GOALS intervention
measure: Post-Intervention Survey
timeFrame: Post-Intervention (3-month, 6-month)
Locations:
city: San Diego
country: United States
facility: Family Health Centers of San Diego
state: California
city: San Diego
country: United States
facility: SDSU HealthLINK Center
state: California
Study officials:
affiliation: San Diego State University
name: Katrina Monroe, PT, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Sara Gombatto, PT, Ph.D
role: PRINCIPAL_INVESTIGATOR
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