Goal Oriented Activity for Latinos With Spine Pain

Chronic Pain Clinical Trial

— GOALS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05005416
• Other study ID #: 228489
• Secondary ID: U54MD012397
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Chronic Pain
• Low Back Pain
• Neck Pain

Intervention

Behavioral:
• GOALS Intervention
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 Therapy
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).

Locations

Country	Name	City	State
United States	Family Health Centers of San Diego	San Diego	California
United States	SDSU HealthLINK Center	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
San Diego State University	Family Health Centers of San Diego, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Archer 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. — View Citation

Bennell 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. — View Citation

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Hogg-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. — View Citation

Hollingshead 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. — View Citation

Hoy 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. — View Citation

Hoy 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. — View Citation

Kamper 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. — View Citation

Katz 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. — View Citation

Mackey 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. — View Citation

Nielsen 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. — View Citation

Plesh 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. — View Citation

Rahim-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. — View Citation

Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003 Nov 12;290(18):2443-54. doi: 10.1001/jama.290.18.2443. — View Citation

Turner JA, Mancl L, Aaron LA. Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial. Pain. 2006 Apr;121(3):181-194. doi: 10.1016/j.pain.2005.11.017. Epub 2006 Feb 21. — View Citation

Van Dyke BP, Newman AK, Morais CA, Burns JW, Eyer JC, Thorn BE. Heterogeneity of Treatment Effects in a Randomized Trial of Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care for Multiply Disadvantaged Patients With Chronic Pain. J Pain. 2019 Oct;20(10):1236-1248. doi: 10.1016/j.jpain.2019.04.006. Epub 2019 Apr 22. — View Citation

Woods MP, Asmundson GJG. Evaluating the efficacy of graded in vivo exposure for the treatment of fear in patients with chronic back pain: a randomized controlled clinical trial. Pain. 2008 Jun;136(3):271-280. doi: 10.1016/j.pain.2007.06.037. Epub 2007 Aug 22. — View Citation

Zettel-Watson L, Rutledge DN, Aquino JK, Cantero P, Espinoza A, Leal F, Jones CJ. Typology of chronic pain among overweight Mexican Americans. J Health Care Poor Underserved. 2011 Aug;22(3):1030-47. doi: 10.1353/hpu.2011.0092. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Expectancy Measure	To assess participant expectancy related to treatment condition assigned. Scale values: 0 (min) to 10 (max). Higher scores indicate better therapeutic alliance.	Baseline
Other	Kim Alliance Scale (KAS)	To assess therapeutic alliance for the treatment condition rendered. Scale values: 16 (min) to 64 (max). Higher scores indicate better therapeutic alliance.	Post-Intervention (1-week)
Other	Global Impression of Change (GIC)	To assess self-reported improvement with intervention. Scale values: 1 (min) to 7 (max). Lower scores indicate better outcomes.	Post-Intervention (1-week, 3-month, 6-month)
Other	Global Rating of Satisfaction (GRS)	To assess self-reported satisfaction with intervention. Scale values: 1 (min) to 7 (max). Lower scores indicate better outcomes.	Post-Intervention (1-week, 3-month, 6-month)
Other	Fear Avoidance Beliefs Questionnaire (FABQ)	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.	Baseline; Post Intervention (1-week, 3-month)
Other	Pain Catastrophizing Scale (PCS)	To assess pain catastrophizing. Scale values: 0 (min) to 52 (max). Decrease in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	Medical Outcomes Study - Social Support Measure (MOS-SS)	To assess social support. Scale values: 0% (min) to 100% (max). Increase in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week)
Other	New General Self-Efficacy Scale (GSES)	To assess general self-efficacy. Scale values: 1 (min) to 5 (max). Increase in scores indicate an improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	Pain Self-Efficacy Questionnaire (PSEQ)	To assess self-efficacy specifically related to pain. Scale values: 0 (min) to 60 (max). Increase in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	PROMIS Short-Form Anxiety 4a	To assess generalized anxiety. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	PROMIS Short-Form Depression 4a	To assess depressive symptoms. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	PROMIS Short-Form Sleep Disturbance	To assess sleep disturbance. Scale values: 0 (min) to 100 (max). Decrease in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	PROMIS Short-Form Physical Function 4a	To assess generalized physical function. Scale values: 0 (min) to 100 (max). Increase in scores indicate improvement in outcomes.	Baseline, Post-Intervention (1-week, 3-month)
Other	PROMIS Short-Form Ability to Participate 4a	To assess participation in social roles and activities. Scale values: 0 (min) to 100 (max). Increase in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	Rapid Assessment of Physical Activity (RAPA) Aerobic	To assess self-reported physical activity. Aerobic scale values: 1 (min) to 7 (max). Increase in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	Rapid Assessment of Physical Activity (RAPA) Strength and Flexibility	To assess self-reported physical activity. Strength & Flexibility scale values: 0 (min) to 3 (max). Increase in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	Self-Efficacy and Exercise Habits Survey (SEHS)	To assess self-efficacy specifically related to exercise. Scale values: 1 (min) to 5 (max). Increase in scores indicate improvement in outcomes.	Baseline; Post-Intervention (1-week, 3-month)
Other	Physical Activity (Actigraph)	Objective measure of physical activity. Physical activity scale values: 0% (min) to 100% (max) (increase in score indicate improvement in outcomes.)	Baseline; Post-Intervention (1-week)
Other	Physical Activity and Sedentary Behavior (Actigraph)	Objective measures of physical activity. Sedentary behavior scale values: 0% (min) to 100% (max) (decrease in score indicate improvement in outcomes.)	Baseline; Post-Intervention (1-week)
Other	Sleep Efficiency (Actigraph)	Objective measure of sleep behavior. Efficiency 0-100% (increase is an improvement).	Baseline; Post-Intervention (1-week)
Other	Sleep Duration (Actigraph)	Objective measure of sleep behavior. Time Asleep in minutes (increase is an improvement).	Baseline; Post-Intervention (1-week)
Other	Sleep Onset (Actigraph)	Objective measure of sleep behavior. Sleep Onset Latency in minutes (decrease is an improvement).	Baseline; Post-Intervention (1-week)
Other	Posture and Movement Measures (DorsaVi)	To assess spine posture and movement and associated pain behavior during clinical tests and daily activities.	Baseline; Post-Intervention (1-week)
Other	Goal Attainment Scale	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.	Once weekly during 8-week GOALS intervention
Other	Adverse Event Checklist	To assess type and frequency of treatment-related adverse events.	Once weekly during 8-week GOALS intervention
Other	Post-Intervention Survey	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.	Post-Intervention (3-month, 6-month)
Primary	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	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.	Change from Baseline to Post-Intervention (3-month, 6-month)
Secondary	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.	Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Secondary	PEG-3	To assess global pain intensity and pain interference. Scale values: 0 (min) to 10 (max). Decrease in score indicate improvement in outcomes.	Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Secondary	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.	Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Secondary	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.	Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Secondary	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.	Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Secondary	6-Meter Walk Test	To assess preferred and maximum gait speeds. Scale is measured in seconds. Decrease in score indicate improvement in outcomes.	Change from Baseline to Post-Intervention (1-week)
Secondary	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.	Change from Baseline to Post-Intervention (1-week)