Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)

NCT04656340 | Completed

• 3 other identifiers: 215050DM140424K24NR015340
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

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

  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 Impact Score is computed by subtracting baseline Impact Score from the score at the time of reassessment. Improvement is indicated by change scores with negative 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.

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

  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

  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 (75)

• 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.

• 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 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 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.

Study Arms (2)

Standard rehabilitative care (SC)

ACTIVE COMPARATOR

Twice weekly physical therapy, occupational therapy and pain psychoeducation

Other: non-medication, non-interventional therapies

Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC)

EXPERIMENTAL

Twice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC

Other: non-medication, non-interventional therapies

Interventions

non-medication, non-interventional therapies OTHER

non-medication, non-interventional therapies

Also known as: Standard rehabilitative therapies (SC) and Complementary and Integrative Health (CIH) therapies

Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC); Standard rehabilitative care (SC)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• U.S. Army Medical Research and Development Command: collaborator
• University of Washington: collaborator
• National Institute of Nursing Research (NINR): collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Related Publications (2)

• 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.

  PMID: 30582069 BACKGROUND

• 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.

  PMID: 34791423 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 7, 2020
• Study Start: December 9, 2015
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share