Chronic Musculoskeletal PainAPPROACHNCT05097521

Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

An observational study of Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Chronic Musculoskeletal Pain
What is being tested?: Practitioner-delivered CIH therapies, Combination of practitioner-delivered and self-care CIH therapies and Self-care CIH therapies
How many people: 3,603 participants
Where: 2 sitesUnited States
Study dates: 17 Mar 2021to 17 Sep 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 89 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343

Other trials in United States

About this study

Official title: Complementary and Integrative Health for Pain in the VA: A National Demonstration Project (NIH-VA-DOD Joint Initiative)

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.

Read the detailed description

Design: The investigators are employing a quasi-experimental encouragement study design in which subjects are able to choose their own CIH therapies, but some are offered extra encouragements (nudges) to choose specific CIH therapies. Instead of being randomized to a CIH therapy, individuals will enter one of three study groups - Veterans Using Practitioner Delivered CIH Therapies Only, Veterans Using Self-Care CIH Therapies Only, or Veterans Using a Combination of Practitioner-Delivered and Self-Care CIH Therapies (Dual-Care) - based on what CIH therapies they used six months after they initiate any CIH therapy. Although accrual to study group is not random, some sites have strong business practices/nudges that lead to considerable variation in which CIH therapies patients use. The variation induced by these business practices/nudges provides a quasi-experimental natural experiment that can be assessed through an instrumental variables analytic approach. The purpose of using business practices as an instrument for accruing patients to treatment groups, similar to the use of randomization, is to reduce potential selection and confounding bias. The six-month treatment window will allow for patients to initiate one type of CIH therapy and add additional CIH therapies based on business practices/nudges at their site within the evaluation period. The CIH therapies that patients receive will be as they are delivered by the 18 VHA Whole Health flagship study sites and community care practices.

The APPROACH study was initially envisioned to examine primary and secondary outcomes for the above-named three study groups. Due to the study's pragmatic design and sampling approach, the sample size of the Veterans Using Self-Care CIH Therapies Only group did not meet the minimum threshold necessary to detect between-group differences of interest. It was therefore determined that study revisions would be necessary.

Sites: The study sites are the VA's 18 Whole Health Flagship sites: VA Boston Health Care System, VA New Jersey Health Care System, Erie VAMC, Beckley VAMC, W. G. (Bill) Hefner VAMC, Atlanta VAMC, Tampa VAMC, Tennessee Valley Health Care System, Aleda E. Lutz VAMC, Tomah VAMC, St. Louis VA Health Care System, Central Arkansas Veterans Healthcare System, South Texas Veterans Health Care System, Salt Lake City VAMC, VA Portland Health Care System, Palo Alto VAMC, Tucson VAMC, VA Nebraska-Western Iowa Health Care System).

Secondary Data from the VA Office of Patient Centered Care and Cultural Transformation's Complementary and Integrative Health Therapy Patient Experience Survey: The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by VA OPCC\&CT's four timepoint survey (baseline and months 1, 3, 6). Almost all of the outcomes listed below are from that survey.

Conditions: Chronic Musculoskeletal Pain
Being tested: Practitioner-delivered CIH therapies, Combination of practitioner-delivered and self-care CIH therapies, Self-care CIH therapies
Keywords: Complementary Therapies, Chronic Pain, Integrative Medicine, Chiropractic, Acupuncture, Yoga, Tai Chi, Meditation, Therapeutic Massage, Qigong, Complementary and Integrative Health
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Practitioner-delivered CIH therapiesOther
Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings
Combination of practitioner-delivered and self-care CIH therapiesOther
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
Self-care CIH therapiesOther
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings

Study groups in NCT05097521
Study group	Role	What they receive
Veterans using practitioner-delivered CIH therapies only		Veterans using practitioner-delivered CIH therapies only Receives: 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) Receives: 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 Receives: Other: Self-care CIH therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Pain Inventory (BPI) Severity Scale
Measure of pain severity. Scores range from 0-10, with higher scores indicating more severe pain.
Measured: 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.
Measured: Change from baseline to 6 months

Secondary outcomes (9)

Patient Global Impression of Change (PGIC) for Improvement in Pain
Single-item scale which assesses how much a patient perceives their pain has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse pain outcomes following the specified intervention.
Measured: 6 months
Patient Global Impression of Change (PGIC) for Improvement in Mental Health
Single-item scale which assesses how much a patient perceives their mental health has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse mental health outcomes following the specified intervention.
Measured: 6 months
Patient Global Impression of Change (PGIC) for Improvement in Fatigue
Single-item scale which assesses how much a patient perceives their fatigue has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse fatigue outcomes following the specified intervention.
Measured: 6 months
Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being
Single-item scale which assesses how much a patient perceives their overall well-being has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse overall well-being outcomes following the specified intervention.
Measured: 6 months
PROMIS10 Global Assessment of Physical Health
Assesses physical function, fatigue, pain, and social health; score derived from the PROMIS10 Global Health measure which assesses physical and mental health and generates two summary scores: Global Physical Health and Global Mental Health.
Scores are reported on a T-score metric wherein the mean score of the general population is standardized to 50 with a standard deviation of 10. A score of 50 indicates average physical health, as compared to the general population. Higher scores indicate better physical health.
Measured: Change from baseline to 6 months
PROMIS10 Global Assessment of Mental Health
Assesses emotional distress and mental health; score derived from the PROMIS10 Global Health measure which assesses physical and mental health and generates two summary scores: Global Physical Health and Global Mental Health.
Scores are reported on a T-score metric wherein the mean score of the general population is standardized to 50 with a standard deviation of 10. A score of 50 indicates average mental health, as compared to the general population. Higher scores indicate better mental health.
Measured: Change from baseline to 6 months
Life Engagement Test (LET)
6 items are rated on a 5-point Likert scale ranging from 1 to 5. Scores range from 6 to 30, with higher scores indicating better life engagement/purpose in life.
Measured: Change from baseline to 6 months
Perceived Stress Scale (PSS-4)
Measure of perceived stress consisting of 4 items which are each rated on a 5-point scale ranging from 0 to 4. Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Measured: Change from baseline to 6 months
Patient Health Questionnaire (PHQ2)
Measure of depressed mood and anhedonia consisting of 2 items which are each rated on a 7-point scale ranging from 0 to 6. Scores range from 0 to 12, with higher scores indicating more depressive symptoms.
Measured: Change from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202117 Sep 2023

First posted28 Oct 2021
Study start17 Mar 2021
Primary completion17 Sep 2023
Study completion17 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,603 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05097521
Sponsor's protocol ID: SDR 17-306
Acronym: APPROACH
Status last verified: Apr 2026
First submitted: 14 Oct 2021
Last updated: 4 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The United States Department of Veterans Affairs (VA) places legal restrictions on access to Veteran's health care data, which includes both identifiable and de-identified data, and sensitive patient information. The datasets generated and analyzed in this study are derived from two primary data sources: The Veterans Health Administration (VHA) Corporate Data Warehouse and the VHA Office of Patient Centered Care and Cultural Transformation's Complementary and Integrative Health Therapy Patient Experience Survey. As they are secondary analyses, study data will not be made available to others. However, programming code generated by this study is available by author request to facilitate reproducibility of study findings by supporting the extraction and transformation of identical data from VA data sources.

Publications

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.
PubMed 32522024
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.
PubMed 33313736
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.
PubMed 34791412
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.
PubMed 35867052
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.
PubMed 36574858
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.
PubMed 41771006
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(Suppl 1):S54-S63. doi: 10.1093/pm/pnae070.
PubMed 39514886
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.
PubMed 39258762
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.
PubMed 41399479

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complementary and Integrative Health for Pain in the VA: A National Demonstration Project (NIH-VA-DOD Joint Initiative)
ClinicalTrials.gov ID: NCT05097521
Acronym / sponsor ID: APPROACH / SDR 17-306
Conditions: Chronic Musculoskeletal Pain
Keywords: Complementary Therapies, Chronic Pain, Integrative Medicine, Chiropractic, Acupuncture, Yoga, Tai Chi, Meditation
Study type: Observational
Recruitment status: Completed
Enrolment: 3,603 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Veterans Health Administration Office of Patient Centered Care & Cultural Transformation
Study start: 17 Mar 2021 (actual)
Primary completion: 17 Sep 2023 (actual)
Study completion: 17 Sep 2023 (actual)
First posted: 28 Oct 2021 (actual)
Results: Posted 4 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Veterans using practitioner-delivered CIH therapies only	–	Other: Practitioner-delivered CIH therapiesVeterans using practitioner-delivered CIH therapies only
Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)	–	Other: Combination of practitioner-delivered and self-care CIH therapiesVeterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)
Veterans using self-care CIH therapies only	–	Other: Self-care CIH therapiesVeterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

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
Practitioner-delivered CIH therapiesPractitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings	Other	Veterans using practitioner-delivered CIH therapies only
Combination of practitioner-delivered and self-care CIH therapiesCombination 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	Other	Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)
Self-care CIH therapiesVeterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings	Other	Veterans using self-care CIH therapies only

Primary outcome

Brief Pain Inventory (BPI) Severity Scale
Time frame: Change from baseline to 6 months
Measure of pain severity. Scores range from 0-10, with higher scores indicating more severe pain.
Brief Pain Inventory (BPI) Interference Scale
Time frame: Change from baseline to 6 months
Measure of pain-related functional interference. Scores range from 0-10, with higher scores indicating greater pain-related functional interference.

9 secondary outcomes

Patient Global Impression of Change (PGIC) for Improvement in Pain
Time frame: 6 months
Patient Global Impression of Change (PGIC) for Improvement in Mental Health
Time frame: 6 months
Patient Global Impression of Change (PGIC) for Improvement in Fatigue
Time frame: 6 months
Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being
Time frame: 6 months
PROMIS10 Global Assessment of Physical Health
Time frame: Change from baseline to 6 months
PROMIS10 Global Assessment of Mental Health
Time frame: Change from baseline to 6 months
Life Engagement Test (LET)
Time frame: Change from baseline to 6 months
Perceived Stress Scale (PSS-4)
Time frame: Change from baseline to 6 months
Patient Health Questionnaire (PHQ2)
Time frame: Change from baseline to 6 months

Results and safety

Results posted to the registry on 4 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Veterans Using Practitioner-delivered CIH Therapies Only	1,688	1,688
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)	1,618	1,618
Veterans Using Self-care CIH Therapies Only	297	297

Primary outcome: Brief Pain Inventory (BPI) Severity Scale

Time frame: Change from baseline to 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Veterans Using Practitioner-delivered CIH Therapies Only n = 952	Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care) n = 1426	Veterans Using Self-care CIH Therapies Only n = 297
Baseline	5.9 (1.7)	6.0 (1.7)	6.3 (1.7)
Six-Month Follow-Up	5.3 (1.9)	5.4 (1.8)	5.9 (1.7)
Difference	-0.6 (1.6)	-0.5 (1.6)	-0.3 (1.6)

Veterans Using Practitioner-delivered CIH Therapies Only vs Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care): Mean Difference (Final Values): -0.12 (95% CI -0.28 to 0.05), p = 0.160, Regression, Linear

Population analysed: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. 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.

Primary outcome: Brief Pain Inventory (BPI) Interference Scale

Time frame: Change from baseline to 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Veterans Using Practitioner-delivered CIH Therapies Only n = 947	Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care) n = 1426	Veterans Using Self-care CIH Therapies Only n = 230
Baseline	6.3 (2.2)	6.6 (2.2)	6.8 (2.1)
Six-Month Follow-Up	5.7 (2.4)	5.9 (2.4)	6.4 (2.3)
Difference	-0.6 (2.0)	-0.7 (2.1)	-0.5 (2.0)

Veterans Using Practitioner-delivered CIH Therapies Only vs Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care): Mean Difference (Final Values): -0.01 (95% CI -0.14 to 0.11), p = 0.847, Regression, Linear

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Veterans Using Practitioner-delivered CIH Therapies Only	0 of 0	0 of 0
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)	0 of 0	0 of 0
Veterans Using Self-care CIH Therapies Only	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32522024Zeliadt 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.
Background: PubMed 33313736Zeliadt 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.
Background: PubMed 34791412Ali 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.
Background: PubMed 35867052Der-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.
Background: PubMed 36574858Kerns 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.
Results publication: PubMed 41771006Zeliadt 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.
Results publication: PubMed 39514886Zeliadt 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(Suppl 1):S54-S63. doi: 10.1093/pm/pnae070.
Results publication: PubMed 39258762Haderlein 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.
Results publication: PubMed 41399479Medich 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.
Individual participant dataSharing planned: No. The United States Department of Veterans Affairs (VA) places legal restrictions on access to Veteran's health care data, which includes both identifiable and de-identified data, and sensitive patient information. The datasets generated and analyzed in this study are derived from two primary data sources: The Veterans Health Administration (VHA) Corporate Data Warehouse and the VHA Office of Patient Centered Care and Cultural Transformation's Complementary and Integrative Health Therapy Patient Experience Survey. As they are secondary analyses, study data will not be made available to others. However, programming code generated by this study is available by author request to facilitate reproducibility of study findings by supporting the extraction and transformation of identical data from VA data sources.

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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.

Stephanie L Taylor, PhD MPH principal investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Steven B. Zeliadt, PhD MPH principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Musculoskeletal Pain, run by VA Office of Research and Development 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 3 inclusion and 4 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 4 May 2026. 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?

Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) Severity Scale (time frame: Change from baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT05097521, which also lists 9 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 4 May 2026.