Goal Oriented Activity for Latinos With Spine Pain

NCT05005416 | Completed DMC

• 2 other identifiers: 228489U54MD012397
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Neck Pain; Chronic Pain; Chronic Low-back Pain

Keywords

physical therapy; rehabilitation; cognitive behavioral; hispanic; health disparities; telehealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Brief Pain Inventory (BPI) - Pain Interference

  Change from Baseline to Post-Intervention (3-month, 6-month)

• Brief Pain Inventory (BPI) - Pain Intensity

  Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)

• PEG-3

  Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)

• Neck Disability Index (NDI)

  Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)

• Modified Oswestry Disability Index (ODI)

  Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)

Other Outcomes (26)

• Treatment Expectancy Measure

  Baseline

• Kim Alliance Scale (KAS)

  Post-Intervention (1-week)

• Global Impression of Change (GIC)

  Post-Intervention (1-week, 3-month, 6-month)

Study Arms (2)

GOALS Intervention

EXPERIMENTAL

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

Usual Care Physical Therapy

ACTIVE COMPARATOR

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

Interventions

GOALS Intervention BEHAVIORAL

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.

GOALS Intervention

Usual Care Physical Therapy BEHAVIORAL

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).

Usual Care Physical Therapy

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to physical therapy by primary care physician
• years old
• Hispanic
• Diagnosis of chronic neck or low back pain
• Must attend at least 1 physical therapy treatment session

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Family Health Centers of San Diego: collaborator

Study Sites (2)

Family Health Centers of San Diego

San Diego, California, 92103, United States

Location

SDSU HealthLINK Center

San Diego, California, 92182, United States

Location

Related Publications (22)

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• Gombatto SP, Archer KR, Wegener ST, Hernandez Y, Lin SF, Godino J, Van Dyke J, Liu J, Monroe KS. Protocol for a Parallel Group Randomized Clinical Trial Comparing a Culturally Adapted Cognitive Behavioral Telerehabilitation Intervention to Usual Physical Therapy for Latino Patients With Chronic Spine Pain. Phys Ther. 2023 Sep 1;103(9):pzad068. doi: 10.1093/ptj/pzad068.

  PMID: 37364033 DERIVED

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katrina Monroe, PT, Ph.D

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Sara Gombatto, PT, Ph.D

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: August 4, 2021
• Primary Completion: July 23, 2024
• Study Completion: December 16, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 5 years following article publication.
• Access Criteria: 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.

Locations

US (2)