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

NCT02906358 | Completed Results

• 1 other identifier: HSC20150600H
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Five Times Sit-to-stand (5XSTS)

  Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.

  Change from Baseline sit-to-stand at 3 and 6 months

Secondary Outcomes (11)

• 50-foot Speed Walk (50FtSW)

  Change from Baseline 50-foot speed walk at 3 and 6 months

• Patient Specific Functional Scale (PSFS)

  Change from Baseline PSFS at 3 and 6 months

• Symbol-Digit Modalities Test (SDMT)

  Change from Baseline SDMT at 3 and 6 months

• The Brief Pain Inventory (BPI): Severity

  Change from Baseline BPI at 3 and 6 months

• The Brief Pain Inventory (BPI): Interference

  Change from Baseline BPI at 3 and 6 months

Study Arms (2)

Community-based pain self-management

ACTIVE COMPARATOR

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)

Behavioral: Community-based pain self-management

Clinic-based pain self-management

ACTIVE COMPARATOR

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

Behavioral: Clinic-based pain self-management

Interventions

Community-based pain self-management BEHAVIORAL

Community-based pain self-management

Clinic-based pain self-management BEHAVIORAL

Clinic-based pain self-management

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The University of Texas at San Antonio: collaborator
• Bexar County Hospital District DBA University Health System: collaborator
• San Antonio Public Libraries: collaborator
• South Central Area Health Education Center: collaborator
• The University of Texas System Healthcare Safety & Effectiveness Grants Program: collaborator

Related Publications (19)

• 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.

  PMID: 25581257 BACKGROUND

• 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.

  PMID: 16054407 BACKGROUND

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

  PMID: 7154893 BACKGROUND

• 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.

  PMID: 16962238 BACKGROUND

• 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.

  PMID: 16055269 BACKGROUND

• 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.

  BACKGROUND

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

  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.

  PMID: 27793191 BACKGROUND

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

  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.

  PMID: 23783372 BACKGROUND

• 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.

  PMID: 11856064 BACKGROUND

• 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.

  PMID: 17065542 BACKGROUND

• 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.

  PMID: 21904240 BACKGROUND

• 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.

  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.

  PMID: 24828475 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

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

  PMID: 8080219 BACKGROUND

• 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.

  PMID: 30312459 DERIVED

• 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.

  PMID: 29299814 DERIVED

Related Links

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

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations of our study include the absence of a control group to gain clinic support, unanticipated adverse events, challenges recruiting and retaining subjects, lack of long-term follow-up and possible lack of generalizability.

Results Point of Contact

• Title: Barbara J Turner
• Organization: The University of Texas Health Science Center at San Antonio

turner@uthscsa.edu

210-562-5551

Study Officials

• Barbara J Turner, MD

  UT Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share