Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics

NCT ID: NCT02906358

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to conduct a parallel group, randomized trial of a chronic pain self-management program in clinic or community settings to educate and support low-income, Hispanic patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.

Detailed Description

Background and Significance

Over the past two decades, opioid analgesic (OA) drugs have been increasingly prescribed for chronic pain despite little to no effectiveness of treatment >6 months. In prospective cohorts, OA therapy can worsen pain and disability by promoting a sedentary lifestyle. With rapidly rising deaths from OA overdose and the lack of evidence of long-term effectiveness, the U.S. Department of Health and Human Services (HHS) has developed its National Pain Strategy that sharply limits use of OAs and recommends non-pharmacologic interventions as first line approaches to manage chronic pain. A key aspect of a non-pharmacologic approach to managing chronic pain is educating patients about self-management in order to help them lead more productive lives and perform daily activities despite their pain. Self-management training is especially important for low-income patients who need practical, low cost ways to learn how to live fuller, more productive lives despite having chronic pain. To respond to this need to support low-income patients with chronic pain, we developed a chronic pain self-management program based on unmet needs identified by stakeholders from rural, largely Hispanic communities. We conducted a randomized trial to examine outcomes of two settings to deliver this self-management training program. Both settings evaluated whether patients' function improved when the same program was delivered in clinic in individual meetings with a trained community health worker or in a local community-based setting from group lectures by content experts. The training program in both settings offered education and training about such topics as: pain physiology and goal setting; stretching; strengthening; massage, and mindfulness techniques. This program not only reflects the unmet needs of rural, predominantly Hispanic stakeholders with chronic pain but also elements of other self-management programs for patients with chronic back and lower extremity musculoskeletal pain. However, this program was specifically designed for a low literacy, bilingual patient population with limited access to resources to help with non-pharmacologic management of chronic pain.

Objective:

To develop a chronic pain self-management program reflecting community stakeholders' priorities and conduct a randomized trial to evaluate functional outcomes from training in two settings. Subjects will be randomized to receive a 6-month pain self-management training program in: 1) Six 30-to-45 minute individual meetings with a trained community health worker in clinic or 2) nine 1-hour meetings for group lectures by content experts and practicing physical activities held in nearby public libraries.

Study Design:

The investigators conducted a parallel group, randomized trial of clinic- and community-based programs to educate and promote pain self-management among low-income, predominantly Hispanic patients aged 35-70 who had been prescribed at least two months of OA therapy for chronic non-cancer back and lower extremity pain. Patients were recruited from two primary care clinics and one HIV clinic that treat low-income patients. A total of 111 subjects were randomized to: 1) clinic-based meetings one-on-one with a trained community health worker, or 2) a community-based program in a local library with group lectures by content experts and training in exercises. The same low literacy PowerPoint educational program in Spanish or English was presented to both study arms except in the community, eight lectures about chronic pain self-management were presented plus one lecture about using library resources (biweekly for three months then monthly for three months). Whereas, in the clinic arm, the content was condensed to be covered in six monthly 30-45 minute meetings with the community health worker. To increase availability for subjects in the community arm, the same group session was offered twice a week. Sessions included: 1) Orientation to the pain program; 2) Pain physiology exercises/stretching; 3) Stress management and mindfulness; 4) Massage therapy approaches; 5) Nutrition; 6) Sleep hygiene; 7) Relapse prevention; 8) Health literacy (Internet resources); and 9) Review and long-term pain self-management strategies. To keep the group size manageable, the pain self-management program was held in two cohorts to meet library and clinic space limitations.

All subjects received copies of slides from sessions with photos of local Hispanic community members performing stretching and strengthening exercises at different levels of difficulty. Participants also received activity logs to track personal goals, program DVDs (walking exercises, self-massage techniques), exercise mats, tennis balls for massage and multi-pronged self-massage tools. Physical therapy students helped patients select personalized goals for physical activities. All participants received text messages and phone calls from a coordinator (community) or a community health worker (clinic) to review progress and reinforce meeting attendance. Missed sessions were made up with a coordinator (community arm) or a community health worker (clinic arm).

Baseline and follow-up measures were conducted by physical therapy students, CHWs, or team members not involved in that study arm. Twelve measures of physical, cognitive, and psychological, function and pain were assessed at 6 months in the clinic or the community location and 6 of these were also assessed at 3 months. The primary outcome measure was the five times sit-to-stand test (5XSTS) that was assessed at both 3 and 6 months and reflects both lower extremity strength and balance. The 5XSTS is significantly associated with disability and risk of falls. Secondary outcomes include: 6-minute distance walk test (6MW); Borg Perceived Effort test (Borg effort); 50-foot speed walk test (50FtSW); 12-Item Short Form Survey Physical Component Summary (SF-12 PCS); and Patient Specific Functional Scale (PSFS). Measures of psychological function include: 12-Item Short Form Survey Mental Component Summary (SF-12 MCS), Brief Pain Inventory (BPI), Patient Health Questionnaire-9 (PHQ-9) and the Tampa Scale for Kinesiophobia (TSK). To assess cognitive function, the Symbol-Digit Modalities Test (SDMT) evaluates attention and psychomotor speed. All measures were performed at baseline and the 6-month study endpoint except the following measures also assessed at three months: 5XSTS, 50FtSW, BPI, PSFS and SDMT. These are all validated functional measures (see below). The practical self-management training program evaluated in this trial may offer a valuable resource for primary care practices striving to support their patients with chronic pain, especially those with limited access to other resources.

Impact:

If either or both of the approaches to deliver this chronic pain self-management training program improve patient functional outcomes, they can be easily replicated to evaluate in other low-income populations to improve function and possibly even reduce dependence on OA therapy.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Community-based pain self-management

Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)

Group Type: ACTIVE_COMPARATOR

Community-based pain self-management

Intervention Type: BEHAVIORAL

Clinic-based pain self-management

Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)

Group Type: ACTIVE_COMPARATOR

Clinic-based pain self-management

Intervention Type: BEHAVIORAL

Interventions

Community-based pain self-management

Intervention Type: BEHAVIORAL

Clinic-based pain self-management

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Active patient in two study primary care clinics or HIV clinic in same system
• Prescribed OAs >2 mos in the past year
• Back/lower extremity pain
• English or Spanish speaking

Exclusion Criteria

• Unstable comorbidity
• Cardiovascular/pulmonary disease that prevents exercise
• Cancer-related pain
• Significant mental health disorder
• Alcohol or drug abuse
• Inability to walk unassisted for at least one block
• Inability to provide consent (e.g., dementia)
• Residing more than 10 miles from clinic (poor transportation)
• Patients who are unable or unwilling to attend clinic- or community-based sessions

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas at San Antonio

OTHER

Sponsor Role: collaborator

Bexar County Hospital District DBA University Health System

OTHER

Sponsor Role: collaborator

San Antonio Public Libraries

UNKNOWN

Sponsor Role: collaborator

South Central Area Health Education Center

UNKNOWN

Sponsor Role: collaborator

The University of Texas System Healthcare Safety & Effectiveness Grants Program

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J Turner, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health Science Center at San Antonio

References

Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.

Reference Type: BACKGROUND

PMID: 25581257 (View on PubMed)

Jensen MK, Thomsen AB, Hojsted J. 10-year follow-up of chronic non-malignant pain patients: opioid use, health related quality of life and health care utilization. Eur J Pain. 2006 Jul;10(5):423-33. doi: 10.1016/j.ejpain.2005.06.001. Epub 2005 Jul 28.

Reference Type: BACKGROUND

PMID: 16054407 (View on PubMed)

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

Reference Type: BACKGROUND

PMID: 7154893 (View on PubMed)

French DJ, France CR, Vigneau F, French JA, Evans RT. Fear of movement/(re)injury in chronic pain: a psychometric assessment of the original English version of the Tampa scale for kinesiophobia (TSK). Pain. 2007 Jan;127(1-2):42-51. doi: 10.1016/j.pain.2006.07.016. Epub 2006 Sep 7.

Reference Type: BACKGROUND

PMID: 16962238 (View on PubMed)

Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.

Reference Type: BACKGROUND

PMID: 16055269 (View on PubMed)

Simmonds MJ, Ortega C, Simmonds KP. Pain, Emotion and Cognition. ln: Pickering G, Gibson S, eds. Switzerland: Springer International Publishing; c2015. Chapter 11, Physical Therapy and Exercise: Impacts on Pain, Mood, Cognition, and Function; p. 167-186.

Reference Type: BACKGROUND

Smith A. Symbol Digits Modalities Test. Western Psychological Services: Los Angeles, 1982.

Reference Type: BACKGROUND

Valerio MA, Rodriguez N, Winkler P, Lopez J, Dennison M, Liang Y, Turner BJ. Comparing two sampling methods to engage hard-to-reach communities in research priority setting. BMC Med Res Methodol. 2016 Oct 28;16(1):146. doi: 10.1186/s12874-016-0242-z.

Reference Type: BACKGROUND

PMID: 27793191 (View on PubMed)

Butler DS, Moseley GL. Explain Pain. Adeliade, South Australia: Noigroup Publications; 2013.

Reference Type: BACKGROUND

Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.

Reference Type: BACKGROUND

PMID: 23783372 (View on PubMed)

Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.

Reference Type: BACKGROUND

PMID: 11856064 (View on PubMed)

Smeets RJ, Hijdra HJ, Kester AD, Hitters MW, Knottnerus JA. The usability of six physical performance tasks in a rehabilitation population with chronic low back pain. Clin Rehabil. 2006 Nov;20(11):989-97. doi: 10.1177/0269215506070698.

Reference Type: BACKGROUND

PMID: 17065542 (View on PubMed)

Bohannon RW. Test-retest reliability of the five-repetition sit-to-stand test: a systematic review of the literature involving adults. J Strength Cond Res. 2011 Nov;25(11):3205-7. doi: 10.1519/JSC.0b013e318234e59f.

Reference Type: BACKGROUND

PMID: 21904240 (View on PubMed)

Ware JE, Kosinski M, Keller SD. SF-12: How to Score the SF-12 Physical and Mental Health Summary Scales. 2nd ed. Boston: The Health Institute; 1995.

Reference Type: BACKGROUND

Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.

Reference Type: BACKGROUND

PMID: 24828475 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type: BACKGROUND

PMID: 11556941 (View on PubMed)

Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

Reference Type: BACKGROUND

PMID: 8080219 (View on PubMed)

Turner BJ, Rodriguez N, Bobadilla R, Hernandez AE, Yin Z. Chronic Pain Self-Management Program for Low-Income Patients: Themes from a Qualitative Inquiry. Pain Med. 2020 Feb 1;21(2):e1-e8. doi: 10.1093/pm/pny192.

Reference Type: DERIVED

PMID: 30312459 (View on PubMed)

Turner BJ, Liang Y, Simmonds MJ, Rodriguez N, Bobadilla R, Yin Z. Randomized Trial of Chronic Pain Self-Management Program in the Community or Clinic for Low-Income Primary Care Patients. J Gen Intern Med. 2018 May;33(5):668-677. doi: 10.1007/s11606-017-4244-2. Epub 2018 Jan 3.

Reference Type: DERIVED

PMID: 29299814 (View on PubMed)

Related Links

http://aspe.hhs.gov/sp/reports/2015/OpioidInitiative/ib_OpioidInitiative.pdf

Department of Health and Human Services: ASPE Issue Brief. Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Deaths

http://www.pgapworks.com/en/whatisthepgap/index.php

The Progressive Goal Attainment Program (PGAP®). An Evidence-Based Treatment Program for Reducing Disability Associated with Pain, Depression, Cancer and other Chronic Health Conditions.

http://www.paintoolkit.org/

Moore P, Cole F. The Pain Toolkit.

Other Identifiers

HSC20150600H

Identifier Type: -

Identifier Source: org_study_id