NCT Number: NCT05005416
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.
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Notify Me18 year–66 year
All sexes
Interventional
Not applicable
Family Health Centers of San Diego, San Diego, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Change from Baseline to Post-Intervention (1-week)
To assess global pain-related disability. Scale values: 0 (min) to 10 (max). Decreases in score indicate improvement in outcomes.
Time frame: Change from Baseline to Post-Intervention (3-month, 6-month)
To assess global pain-related disability. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
To assess global pain severity. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
To assess global pain intensity and pain interference. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
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.
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
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.
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
To assess ability to perform patient-identified functional activities. Scale values: 0 (min) to 10 (max). Increase in score indicate improvement in outcomes.
Time frame: Change from Baseline to Post-Intervention (1-week)
To assess preferred and maximum gait speeds. Scale is measured in seconds. Decrease in score indicate improvement in outcomes.
Time frame: Change from Baseline to Post-Intervention (1-week)
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.
Time frame: Baseline
To assess participant expectancy related to treatment condition assigned. Scale values: 0 (min) to 10 (max). Higher scores indicate better therapeutic alliance.
Time frame: Post-Intervention (1-week)
To assess therapeutic alliance for the treatment condition rendered. Scale values: 16 (min) to 64 (max). Higher scores indicate better therapeutic alliance.
Time frame: Post-Intervention (1-week, 3-month, 6-month)
To assess self-reported improvement with intervention. Scale values: 1 (min) to 7 (max). Lower scores indicate better outcomes.
Time frame: Post-Intervention (1-week, 3-month, 6-month)
To assess self-reported satisfaction with intervention. Scale values: 1 (min) to 7 (max). Lower scores indicate better outcomes.
Time frame: Baseline; Post Intervention (1-week, 3-month)
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.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess pain catastrophizing. Scale values: 0 (min) to 52 (max). Decrease in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week)
To assess social support. Scale values: 0% (min) to 100% (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess general self-efficacy. Scale values: 1 (min) to 5 (max). Increase in scores indicate an improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess self-efficacy specifically related to pain. Scale values: 0 (min) to 60 (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess generalized anxiety. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess depressive symptoms. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess sleep disturbance. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.
Time frame: Baseline, Post-Intervention (1-week, 3-month)
To assess generalized physical function. Scale values: 0 (min) to 100 (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess participation in social roles and activities. Scale values: 0 (min) to 100 (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess self-reported physical activity. Aerobic scale values: 1 (min) to 7 (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess self-reported physical activity. Strength & Flexibility scale values: 0 (min) to 3 (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week, 3-month)
To assess self-efficacy specifically related to exercise. Scale values: 1 (min) to 5 (max). Increase in scores indicate improvement in outcomes.
Time frame: Baseline; Post-Intervention (1-week)
Objective measure of physical activity. Physical activity scale values: 0% (min) to 100% (max) (increase in score indicate improvement in outcomes.)
Time frame: Baseline; Post-Intervention (1-week)
Objective measures of physical activity. Sedentary behavior scale values: 0% (min) to 100% (max) (decrease in score indicate improvement in outcomes.)
Time frame: Baseline; Post-Intervention (1-week)
Objective measure of sleep behavior. Efficiency 0-100% (increase is an improvement).
Time frame: Baseline; Post-Intervention (1-week)
Objective measure of sleep behavior. Time Asleep in minutes (increase is an improvement).
Time frame: Baseline; Post-Intervention (1-week)
Objective measure of sleep behavior. Sleep Onset Latency in minutes (decrease is an improvement).
Time frame: Baseline; Post-Intervention (1-week)
To assess spine posture and movement and associated pain behavior during clinical tests and daily activities.
Time frame: Once weekly during 8-week GOALS intervention
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.
Time frame: Once weekly during 8-week GOALS intervention
To assess type and frequency of treatment-related adverse events.
Time frame: Post-Intervention (3-month, 6-month)
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.
San Diego State University
Other
Efficacy of a Culturally Adapted Cognitive Behavioral Based Physical Therapy Intervention for Latinos With Chronic Spine Pain
Acronym: GOALS
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