Clinical trial NCT04656340: Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)
Official title: Enhancing the Success of Functional Restoration Using Integrative Pain Therapies: a Comparative Effectiveness Analysis of Active Duty Service Members With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
Collaborators: name: U.S. Army Medical Research and Development Command
name: University of Washington
name: National Institute of Nursing Research (NINR)
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2020-12-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. In addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response.

SC included physical and occupational therapy. CIH included chiropractic, acupuncture, yoga and foam roller instruction. Both treatment groups also received education about pain psychology.

Participants were randomly assigned to a 3-week course of either SC alone or CIH combined with SC prior to a 3-week course of FR. Outcomes were collected at baseline, at end of stage 1, and post-FR. Outcomes included patient-reported and provider-determined measures.


Eligibility criteria: Inclusion Criteria:

* Significant functional impairment due to pain, requiring modification of military duties.
* Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day:

  1. Can stand up from and sit down on floor independently
  2. Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster.
  3. Able to complete at least 2 of the following:

     1. Lift 20 lbs from floor to knuckle height
     2. Lift 20 lbs from floor to shoulder height
     3. Carry 20lbs at least 40 feet.
* Inadequate response to previous less intensive treatment
* Expresses motivation to take active role in regaining function

Exclusion Criteria:

* Major surgeries within past 6 months or planned within next 6 months
* Unstable psychological disorders
* Active substance use disorder
* High dose opioids of \>120 milligrams of morphine equivalent doses (MED)/day

Primary outcomes:
measure: Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Secondary outcomes:
measure: Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Battery of functional performance measures - Change in walking tolerance from baseline to short-term post-treatment follow-up.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Battery of functional performance measures - Change in walking tolerance from baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 1. Improvement is indicated by change scores with positive values.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of short-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-1.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-2.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to short-term post-treatment follow-up.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to intermediate-term post-treatment follow-up.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 2.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to short-term post-treatment follow-up.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to intermediate-term post-treatment follow-up.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to short-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 1.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 2.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to short-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to short-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 1.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 2.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to short-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 1.
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to short-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to intermediate-term post-treatment follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in Pain Catastrophizing Score (PCS), baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Pain Catastrophizing Score (PCS), baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Pain Catastrophizing Score (PCS), baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Pain Catastrophizing Score (PCS), baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in Patient Activation Measure (PAM), baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Patient Activation Measure (PAM), baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Patient Activation Measure (PAM), baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Patient Activation Measure (PAM), baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Patient Global Impression of Change (PGIC) at end of Stage 2
timeFrame: End of Stage 2 timeline parameters as stated for outcomes 2
measure: Change in Pyramid Measure, baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in Pyramid Measure, baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in Pyramid Measure, baseline to short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in Pyramid Measure, baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 1
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 2
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of short-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
measure: Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to intermediate-term follow-up
timeFrame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Other outcomes:
Locations:
Study officials:
References:
citation: Flynn DM, McQuinn H, Fairchok A, Eaton LH, Langford DJ, Snow T, Doorenbos AZ. Enhancing the success of functional restoration using complementary and integrative therapies: Protocol and challenges of a comparative effectiveness study in active duty service members with chronic pain. Contemp Clin Trials Commun. 2018 Nov 29;13:100311. doi: 10.1016/j.conctc.2018.100311. eCollection 2019 Mar.
citation: Flynn DM, McQuinn H, Burke L, Steffen A, Fairchok A, Snow T, Doorenbos AZ. Use of Complementary and Integrative Health Therapies Before Intensive Functional Restoration in Active Duty Service Members with Chronic Pain. Pain Med. 2022 Apr 8;23(4):844-856. doi: 10.1093/pm/pnab326.