Enhancing the Success of Functional Restoration Using Integrative Pain Therapies: a Comparative Effectiveness Analysis of Active Duty Service Members With Chronic Pain

Madigan Army Medical Center0 sites210 target enrollmentDecember 9, 2015

ConditionsChronic Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Madigan Army Medical Center
Enrollment: 210
Primary Endpoint: Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 9, 2015

End Date

April 2, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Madigan Army Medical Center

Responsible Party

Principal Investigator

Diane Flynn

Principal Investigator

Madigan Army Medical Center

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:
•Can stand up from and sit down on floor independently
•Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster.
•Able to complete at least 2 of the following:
•Lift 20 lbs from floor to knuckle height
•Lift 20 lbs from floor to shoulder height
•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

Outcomes

Primary Outcomes

Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment

Time Frame: 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.

The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to end of stage 2

Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment

Time Frame: 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.

Secondary Outcomes

Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - intermediate-term follow-up(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.)
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.(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.)
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of short-term post-treatment follow-up(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.)
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-1.(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.)
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 1(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.)
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - short-term follow-up(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.)
Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 1(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.)
Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 2(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.)
Battery of functional performance measures - Change in walking tolerance from baseline to intermediate-term post-treatment follow-up(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.)
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 2(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.)
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of intermediate-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 2(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to short-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to intermediate-term post-treatment follow-up(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.)
Battery of functional performance measures - Change in walking tolerance from baseline to short-term post-treatment follow-up.(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.)
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-2.(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.)
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to short-term post-treatment follow-up.(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.)
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 2.(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 1(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to intermediate-term post-treatment follow-up(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.)
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to intermediate-term post-treatment follow-up.(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.)
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to short-term post-treatment follow-up.(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.)
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to intermediate-term post-treatment follow-up.(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 2.(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to short-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to end of stage 1(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 2.(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 1.(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to short-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to short-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to intermediate-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to short-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to intermediate-term post-treatment follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to intermediate-term post-treatment follow-up(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.)
Change in Pain Catastrophizing Score (PCS), baseline to short-term follow-up(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.)
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to short-term follow-up(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.)
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to intermediate-term follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 1.(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 2(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.)
Change in Pain Catastrophizing Score (PCS), baseline to end of stage 1(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.)
Change in Pain Catastrophizing Score (PCS), baseline to intermediate-term follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 1(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 2(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.)
Change in Pain Catastrophizing Score (PCS), baseline to end of stage 2(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 1.(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.)
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 2(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.)
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to intermediate-term follow-up(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.)
Patient Global Impression of Change (PGIC) at end of Stage 2(End of Stage 2 timeline parameters as stated for outcomes 2)
Change in Pyramid Measure, baseline to intermediate-term follow-up(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.)
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 1(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.)
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to short-term follow-up(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.)
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 1(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.)
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to short-term follow-up(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.)
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to intermediate-term follow-up(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.)
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to short-term follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 1(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 2(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.)
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 1(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.)
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 2(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.)
Change in Patient Activation Measure (PAM), baseline to end of stage 2(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.)
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 2(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.)
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to intermediate-term follow-up(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.)
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to of stage 2(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.)
Change in Pyramid Measure, baseline to short-term follow-up(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.)
Change in Patient Activation Measure (PAM), baseline to end of stage 1(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.)
Change in Patient Activation Measure (PAM), baseline to short-term follow-up(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.)
Change in Patient Activation Measure (PAM), baseline to intermediate-term follow-up(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.)
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to end of stage 1(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.)
Change in Pyramid Measure, baseline to end of stage 2(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.)
Change in Pyramid Measure, baseline to end of stage 1(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of short-term follow-up(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.)
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to intermediate-term follow-up(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.)