Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

NCT05097521 | Completed Results

• 1 other identifier: SDR 17-306
• Study Type: observational
• Target: 3,603
• Locations: 1 country
• Sites: 2

Brief Summary

The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the effects of use of practitioner-delivered CIH therapies alone compared to the combination of self-care and practitioner-delivered CIH therapies among Veterans with chronic musculoskeletal pain. The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by the Veterans Health Administration's (VA) Office of Patient Centered Care and Cultural Transformation among Veterans receiving care at one of 18 VA medical centers. Those 18 facilities received funding to expand availability of CIH therapies as part of the Comprehensive Addiction and Recovery Act of 2016. That patient-reported data is being supplemented with VA electronic health record data and data on the 18 medical centers' business practices (nudges, the instrumental variable). Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage; self-care therapies include Tai Chi/Qigong, yoga, and meditation. The primary outcomes are improvement in pain severity and pain interference, assessed using the Brief Pain Inventory (BPI), six months after initiating CIH therapies compared to baseline. Patients will enter treatment groups based on the CIH therapies they use, as randomizing patients to specific therapies would require withholding therapies routinely offered at VA. The investigators will address selection bias and confounding by using sites' variations in business practices and other encouragements (nudges) to receiving different CIH therapies as a surrogate for direct randomization using instrumental variables econometric methods.

Conditions

Chronic Musculoskeletal Pain

Keywords

Complementary Therapies; Chronic Pain; Integrative Medicine; Chiropractic; Acupuncture; Yoga; Tai Chi; Meditation; Therapeutic Massage; Qigong; Complementary and Integrative Health

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI) Severity Scale

  Measure of pain severity. Scores range from 0-10, with higher scores indicating more severe pain.

  Change from baseline to 6 months

• Brief Pain Inventory (BPI) Interference Scale

  Measure of pain-related functional interference. Scores range from 0-10, with higher scores indicating greater pain-related functional interference.

  Change from baseline to 6 months

Secondary Outcomes (9)

• Patient Global Impression of Change (PGIC) for Improvement in Pain

  6 months

• Patient Global Impression of Change (PGIC) for Improvement in Mental Health

  6 months

• Patient Global Impression of Change (PGIC) for Improvement in Fatigue

  6 months

• Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being

  6 months

• PROMIS10 Global Assessment of Physical Health

  Change from baseline to 6 months

Other Outcomes (3)

• Perceived Health Competency Scale (PHCS-2)

  Change from baseline to 6 months

• Altarum Consumer Engagement (ACE)

  Change from baseline to 6 months

• Self-Efficacy for Managing Chronic Disease (SEMCD)

  Change from baseline to 6 months

Study Arms (3)

Veterans using practitioner-delivered CIH therapies only

Veterans using practitioner-delivered CIH therapies only

Other: Practitioner-delivered CIH therapies

Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)

Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)

Other: Combination of practitioner-delivered and self-care CIH therapies

Veterans using self-care CIH therapies only

Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only

Other: Self-care CIH therapies

Interventions

Practitioner-delivered CIH therapies OTHER

Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings

Veterans using practitioner-delivered CIH therapies only

Self-care CIH therapies OTHER

Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings

Veterans using self-care CIH therapies only

Combination of practitioner-delivered and self-care CIH therapies OTHER

Combination of practitioner-delivered (acupuncture, therapeutic massage, chiropractic care) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies as received in VHA and community practice settings

Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe chronic musculoskeletal pain who initiate at least one of the six CIH therapies at the 18 VA Whole Health flagship study sites during the study period who also participate in the VA Office of Patient Centered Care and Cultural Transformations CIH Experience Survey.

You may qualify if:

• Veteran
• History of (chronic) musculoskeletal-related pain conditions recorded in the EHR in the year prior to the index visit, and self-report pain present every day or nearly every day for 3 months from the CIH index visit using an eligibility screener
• Aged 18-89 on index CIH visit date

You may not qualify if:

• Diagnoses of serious mental illness in the year prior to initiating CIH
• History of spinal cord injury
• Hospitalization 30 days prior to initiating CIH
• Recorded CIH use in the EHR in the 6 months prior to the index CIH visit and reported CIH use in the 8 weeks prior to index CIH visit

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Veterans Health Administration Office of Patient Centered Care & Cultural Transformation: collaborator

Study Sites (2)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (9)

• Zeliadt SB, Coggeshall S, Thomas E, Gelman H, Taylor SL. The APPROACH trial: Assessing pain, patient-reported outcomes, and complementary and integrative health. Clin Trials. 2020 Aug;17(4):351-359. doi: 10.1177/1740774520928399. Epub 2020 Jun 10.

  PMID: 32522024 BACKGROUND

• Zeliadt SB, Coggeshall S, Gelman H, Shin MH, Elwy AR, Bokhour BG, Taylor SL. Assessing the Relative Effectiveness of Combining Self-Care with Practitioner-Delivered Complementary and Integrative Health Therapies to Improve Pain in a Pragmatic Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S100-S109. doi: 10.1093/pm/pnaa349.

  PMID: 33313736 BACKGROUND

• Ali J, Antonelli M, Bastian L, Becker W, Brandt CA, Burgess DJ, Burns A, Cohen SP, Davis AF, Dearth CL, Dziura J, Edwards R, Erdos J, Farrokhi S, Fritz J, Geda M, George SZ, Goertz C, Goodie J, Hastings SN, Heapy A, Ilfeld BM, Katsovich L, Kerns RD, Kyriakides TC, Lee A, Long CR, Luther SL, Martino S, Matheny ME, McGeary D, Midboe A, Pasquina P, Peduzzi P, Raffanello M, Rhon D, Rosen M, Esposito ER, Scarton D, Hastings SN, Seal K, Silliker N, Taylor S, Taylor SL, Tsui M, Wright FS, Zeliadt S. Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory. Mil Med. 2022 Jul 1;187(7-8):179-185. doi: 10.1093/milmed/usab458.

  PMID: 34791412 BACKGROUND

• Der-Martirosian C, Shin M, Upham ML, Douglas JH, Zeliadt SB, Taylor SL. Telehealth Complementary and Integrative Health Therapies During COVID-19 at the U.S. Department of Veterans Affairs. Telemed J E Health. 2023 Apr;29(4):576-583. doi: 10.1089/tmj.2022.0209. Epub 2022 Jul 22.

  PMID: 35867052 BACKGROUND

• Kerns RD, Davis AF, Fritz JM, Keefe FJ, Peduzzi P, Rhon DI, Taylor SL, Vining R, Yu Q, Zeliadt SB, George SZ. Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence. J Pain. 2023 Apr;24(4):568-574. doi: 10.1016/j.jpain.2022.12.008. Epub 2022 Dec 24.

  PMID: 36574858 BACKGROUND

• Zeliadt SB, Coggeshall SS, Bokhour B, Elwy AR, Kligler B, Der-Martirosian C, Rosser EW, Shin M, Toyama J, Upham ML, Zhang X, Taylor SL. Adding Self-Care Complementary and Integrative Health Therapies to Care for Chronic Pain: The Assessing Pain, Patient Reported Outcomes and Complementary Health (APPROACH) Study. Med Care. 2026 May 1;64(5):283-292. doi: 10.1097/MLR.0000000000002295. Epub 2026 Mar 2.

  PMID: 41771006 RESULT

• Zeliadt SB, Coggeshall S, Zhang X, Rosser EW, Reed Ii DE, Elwy AR, Bokhour BG, Toyama JA, Taylor SL. How initial perceptions of the effectiveness of mind and body complementary and integrative health therapies influence long-term adherence in a pragmatic trial. Pain Med. 2024 Nov 1;25(Supplement_1):S54-S63. doi: 10.1093/pm/pnae070.

  PMID: 39514886 RESULT

• Haderlein TP, Zeliadt SB, Kloehn AT, Lott BD, Toyama J, Resnick A, Elwy AR, Der-Martirosian C, Taylor SL. Are Virtual Complementary and Integrative Therapies as Effective as In-Person Therapies? Examining Patient-Reported Outcomes Among Veterans with Chronic Musculoskeletal Pain. Telemed J E Health. 2025 Feb;31(2):176-184. doi: 10.1089/tmj.2024.0060. Epub 2024 Sep 11.

  PMID: 39258762 RESULT

• Medich M, Shin MH, McGowan MG, Kasom DR, Lott B, Zeliadt SB, Taylor SL. Patient Reports on How Well Combining Provider-Delivered and Self-Directed Complementary and Integrative Health Therapies Help Their Health and Well-Being. Glob Adv Integr Med Health. 2025 Dec 13;14:27536130251390862. doi: 10.1177/27536130251390862. eCollection 2025 Jan-Dec.

  PMID: 41399479 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.

Results Point of Contact

• Title: Dr. Stephanie L. Taylor
• Organization: VA Greater Los Angeles Health Care System

stephanie.taylor8@va.gov

2135051140

Study Officials

• Stephanie L Taylor, PhD MPH

  VA Greater Los Angeles Healthcare System, Sepulveda, CA

  PRINCIPAL INVESTIGATOR

• Steven B. Zeliadt, PhD MPH

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 28, 2021
• Study Start: March 17, 2021
• Primary Completion: September 17, 2023
• Study Completion: September 17, 2023
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)