CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 138 enrolled
Drug / intervention
GOALS Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05005416
NCT05005416N/ACompleted

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

San Diego State University·interventional·Posted Aug 13, 2021·Updated Feb 10, 2025

In Brief

A clinical study evaluating GOALS Intervention and Usual Care Physical Therapy for Low Back Pain and 3 related conditions. Completed, enrolled 138 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 13, 2021
Enrollment StartAug 4, 2021
Primary CompletionJul 23, 2024
Study CompletionDec 16, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.9 years ago

Interventions

GOALS Interventionbehavioral

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 Physical Therapybehavioral

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).