Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)
NCT ID: NCT04656340
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2015-12-09
2019-04-02
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard rehabilitative care (SC)
Twice weekly physical therapy, occupational therapy and pain psychoeducation
non-medication, non-interventional therapies
non-medication, non-interventional therapies
Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC)
Twice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC
non-medication, non-interventional therapies
non-medication, non-interventional therapies
Interventions
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non-medication, non-interventional therapies
non-medication, non-interventional therapies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Unstable psychological disorders
* Active substance use disorder
* High dose opioids of \>120 milligrams of morphine equivalent doses (MED)/day
18 Years
85 Years
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
University of Washington
OTHER
National Institute of Nursing Research (NINR)
NIH
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Madigan Army Medical Center
FED
Responsible Party
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Diane Flynn
Principal Investigator
References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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DM140424
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
215050
Identifier Type: -
Identifier Source: org_study_id