NCT03297905

Brief Summary

This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

August 8, 2017

Last Update Submit

October 10, 2022

Conditions

Chronic Pain

Keywords

Chronic PainMilitary

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Pain Intensity

    Pain Intensity 10-pt Numeric Rating Scale

    3 months

  • Change from Baseline Pain Impact

    Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)

    3 months

Secondary Outcomes (18)

  • Depression

    baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months

  • Anxiety

    baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months

  • Emotional Distress - Anger

    baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months

  • Sleep Disturbance

    baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months

  • Fatigue

    baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months

  • +13 more secondary outcomes

Study Arms (2)

Complementary and Integrative Therapies

EXPERIMENTAL

Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction

Behavioral: Complementary and Integrative Therapies

Standard Rehabilitative Care

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy

Behavioral: Standard Rehabilitative Care

Interventions

Complementary and Integrative TherapiesBEHAVIORAL

Intervention time period is 3 - 6 weeks.

Complementary and Integrative Therapies
Standard Rehabilitative CareBEHAVIORAL

Intervention time period is 3 - 6 weeks.

Standard Rehabilitative Care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active duty service members
  • Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
  • Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities

You may not qualify if:

  • Major surgeries within past 6 months or planned within next 6 months
  • Unstable psychological disorders
  • Active substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (3)

  • Shimada S, Ledesma S, Flynn DM, Tintle N, Ransom JC, McQuinn HM, Snow TJ, Ieronimakis N, Wi D, Burke LA, Steffen AD, Doorenbos AZ. Evaluating Sex Differences in Biomarkers of Chronic Pain Among Active-Duty Personnel: An Exploratory Analysis of a Pragmatic Clinical Trial With a SMART Design. Biol Res Nurs. 2026 Feb 3:10998004261423210. doi: 10.1177/10998004261423210. Online ahead of print.

    PMID: 41631713DERIVED

  • Wi D, Flynn DM, Park C, Ransom JC, McQuinn HM, Snow TJ, Burke LA, Steffen AD, Shimada S, Doorenbos AZ. Dynamic Interactions in Chronic Pain-Related Outcomes: A Secondary Data Analysis of a Pragmatic Clinical Trial With Sequential, Multiple Assignment, Randomized Trial Design. Mil Med. 2025 Nov 1;190(11-12):e2382-e2390. doi: 10.1093/milmed/usaf225.

    PMID: 40440185DERIVED

  • Flynn DM, Ransom JC, Steffen AD, Orr KP, McQuinn HM, Snow TJ, Burke LA, Wi D, Doorenbos AZ. Complementary, integrative, and standard rehabilitative therapies in a military population with chronic predominantly musculoskeletal pain: a pragmatic clinical trial with SMART design. Pain. 2025 Jun 1;166(6):1343-1353. doi: 10.1097/j.pain.0000000000003462. Epub 2024 Nov 8.

    PMID: 39560398DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ardith Z Doorenbos, RN, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential Multiple Assignment Randomized Trial (SMART)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2017

First Posted

September 29, 2017

Study Start

June 15, 2018

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

US(1)