Low Back PainGOALSNCT05005416
Goal Oriented Activity for Latinos With Spine Pain
A study testing GOALS Intervention in people with Low Back Pain and Neck Pain, run by San Diego State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Low Back Pain, Neck Pain, Chronic Pain
- What is being tested?
- GOALS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2021to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Health Centers of San Diego
San Diego, California, 92103
SDSU HealthLINK Center
San Diego, California, 92182
About this study
Official title: Efficacy of a Culturally Adapted Cognitive Behavioral Based Physical Therapy Intervention for Latinos With Chronic Spine Pain
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.
Read the 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.
- Conditions
- Low Back Pain, Neck Pain, Chronic Pain, Chronic Low-back Pain
- Being tested
- GOALS Intervention, Usual Care Physical Therapy
- Keywords
- physical therapy, rehabilitation, cognitive behavioral, hispanic, health disparities, telehealth
- Medical subject headings
- Low Back Pain, Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOALS InterventionBehavioural
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 TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Post-Intervention (1-week)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to Post-Intervention (1-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start4 Aug 2021
- Primary completion23 Jul 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Family Health Centers of San Diego
- Responsible party
- Sponsor
- Investigators
- Katrina Monroe, PT, Ph.D, Principal investigator, San Diego State UniversitySara Gombatto, PT, Ph.D, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005416
- Sponsor's protocol ID
- 228489
- Other IDs
- U54MD012397
- Acronym
- GOALS
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (including data dictionaries) that underlie the results reported in publications, after deidentification (text, tables, figures, appendices), will be available. Other documents that will be made available include: Study Protocol, Statistical Analysis Plan, Analytic Code, Informed Consent Form, Patient Guide (English/Spanish), and Therapist Guide (English/Spanish). Data will be available for individual participant data meta-analysis beginning 6 months and ending 5 years following article publication.
Publications
Archer KR, Devin CJ, Vanston SW, Koyama T, Phillips SE, Mathis SL, George SZ, McGirt MJ, Spengler DM, Aaronson OS, Cheng JS, Wegener ST. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial. J Pain. 2016 Jan;17(1):76-89. doi: 10.1016/j.jpain.2015.09.013. Epub 2015 Oct 23.
PubMed 26476267Archer KR, Motzny N, Abraham CM, Yaffe D, Seebach CL, Devin CJ, Spengler DM, McGirt MJ, Aaronson OS, Cheng JS, Wegener ST. Cognitive-behavioral-based physical therapy to improve surgical spine outcomes: a case series. Phys Ther. 2013 Aug;93(8):1130-9. doi: 10.2522/ptj.20120426. Epub 2013 Apr 18.
PubMed 23599351Bennell KL, Ahamed Y, Jull G, Bryant C, Hunt MA, Forbes AB, Kasza J, Akram M, Metcalf B, Harris A, Egerton T, Kenardy JA, Nicholas MK, Keefe FJ. Physical Therapist-Delivered Pain Coping Skills Training and Exercise for Knee Osteoarthritis: Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 May;68(5):590-602. doi: 10.1002/acr.22744.
PubMed 26417720da C Menezes Costa L, Maher CG, Hancock MJ, McAuley JH, Herbert RD, Costa LO. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012 Aug 7;184(11):E613-24. doi: 10.1503/cmaj.111271. Epub 2012 May 14.
PubMed 22586331Mackey S. National Pain Strategy Task Force: the strategic plan for the IOM Pain Report. Pain Med. 2014 Jul;15(7):1070-1. doi: 10.1111/pme.12490. No abstract available.
PubMed 25059928Gagnon CM, Matsuura JT, Smith CC, Stanos SP. Ethnicity and interdisciplinary pain treatment. Pain Pract. 2014 Jul;14(6):532-40. doi: 10.1111/papr.12102. Epub 2013 Jul 29.
PubMed 23889982Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, Hurwitz E, Nordin M, Peloso P; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S39-51. doi: 10.1097/BRS.0b013e31816454c8.
PubMed 18204398Hollingshead NA, Ashburn-Nardo L, Stewart JC, Hirsh AT. The Pain Experience of Hispanic Americans: A Critical Literature Review and Conceptual Model. J Pain. 2016 May;17(5):513-28. doi: 10.1016/j.jpain.2015.10.022. Epub 2016 Jan 30.
PubMed 26831836Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
PubMed 24665116Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
PubMed 24482302Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev. 2014 Sep 2;2014(9):CD000963. doi: 10.1002/14651858.CD000963.pub3.
PubMed 25180773Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
PubMed 16595438Nielsen M, Keefe FJ, Bennell K, Jull GA. Physical therapist-delivered cognitive-behavioral therapy: a qualitative study of physical therapists' perceptions and experiences. Phys Ther. 2014 Feb;94(2):197-209. doi: 10.2522/ptj.20130047. Epub 2013 Sep 12.
PubMed 24029300Plesh O, Adams SH, Gansky SA. Racial/Ethnic and gender prevalences in reported common pains in a national sample. J Orofac Pain. 2011 Winter;25(1):25-31.
PubMed 21359234Rahim-Williams B, Riley JL 3rd, Williams AK, Fillingim RB. A quantitative review of ethnic group differences in experimental pain response: do biology, psychology, and culture matter? Pain Med. 2012 Apr;13(4):522-40. doi: 10.1111/j.1526-4637.2012.01336.x. Epub 2012 Mar 5.
PubMed 22390201
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Culturally Adapted Cognitive Behavioral Based Physical Therapy Intervention for Latinos With Chronic Spine Pain
- ClinicalTrials.gov ID
- NCT05005416
- Acronym / sponsor ID
- GOALS / 228489
- Conditions
- Low Back Pain, Neck Pain, Chronic Pain, Chronic Low-back Pain
- Keywords
- physical therapy, rehabilitation, cognitive behavioral, hispanic, health disparities, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Family Health Centers of San Diego
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GOALS Intervention | Experimental | Behavioral: GOALS InterventionThe 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. |
| Usual Care Physical Therapy | Active comparator | Behavioral: Usual Care Physical TherapyThe 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. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOALS InterventionWeekly 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. | Behavioural | GOALS Intervention |
| Usual Care Physical TherapyUsual 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). | Behavioural | Usual Care Physical Therapy |
Primary outcome
Brief Pain Inventory (BPI) - Pain Interference
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.
8 secondary outcomes
Brief Pain Inventory (BPI) - Pain Interference
Time frame: Change from Baseline to Post-Intervention (3-month, 6-month)
Brief Pain Inventory (BPI) - Pain Intensity
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
PEG-3
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Neck Disability Index (NDI)
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Modified Oswestry Disability Index (ODI)
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Patient Specific Functional Scale (PSFS)
Time frame: Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
6-Meter Walk Test
Time frame: Change from Baseline to Post-Intervention (1-week)
30-s Sit-to-Stand
Time frame: Change from Baseline to Post-Intervention (1-week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 26476267Archer KR, Devin CJ, Vanston SW, Koyama T, Phillips SE, Mathis SL, George SZ, McGirt MJ, Spengler DM, Aaronson OS, Cheng JS, Wegener ST. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial. J Pain. 2016 Jan;17(1):76-89. doi: 10.1016/j.jpain.2015.09.013. Epub 2015 Oct 23.
- Background: PubMed 23599351Archer KR, Motzny N, Abraham CM, Yaffe D, Seebach CL, Devin CJ, Spengler DM, McGirt MJ, Aaronson OS, Cheng JS, Wegener ST. Cognitive-behavioral-based physical therapy to improve surgical spine outcomes: a case series. Phys Ther. 2013 Aug;93(8):1130-9. doi: 10.2522/ptj.20120426. Epub 2013 Apr 18.
- Background: PubMed 26417720Bennell KL, Ahamed Y, Jull G, Bryant C, Hunt MA, Forbes AB, Kasza J, Akram M, Metcalf B, Harris A, Egerton T, Kenardy JA, Nicholas MK, Keefe FJ. Physical Therapist-Delivered Pain Coping Skills Training and Exercise for Knee Osteoarthritis: Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 May;68(5):590-602. doi: 10.1002/acr.22744.
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- Individual participant dataSharing planned: Yes. Individual participant data (including data dictionaries) that underlie the results reported in publications, after deidentification (text, tables, figures, appendices), will be available. Other documents that will be made available include: Study Protocol, Statistical Analysis Plan, Analytic Code, Informed Consent Form, Patient Guide (English/Spanish), and Therapist Guide (English/Spanish). Data will be available for individual participant data meta-analysis beginning 6 months and ending 5 years following article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina Monroe, PT, Ph.D principal investigator
San Diego State University
Sara Gombatto, PT, Ph.D principal investigator
San Diego State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOALS Intervention in people with Low Back Pain and Neck Pain, run by San Diego State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) - Pain Interference (time frame: Change from Baseline to Post-Intervention (1-week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005416, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.