An interventional study of Complementary and Integrative Therapies and Standard Rehabilitative Care in Chronic Pain, sponsored by University of Washington. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of disability among active duty military Service members. The injury rate is significant with 628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service members. Neuromusculoskeletal injuries include amputations following battlefield trauma, repetitive motion injuries related to equipment use or weight-bearing postures, and even injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on both individual Service members and military readiness are significant: Only 13% of Service members being treated primarily for pain ever return to the field.
The Department of Defense (DoD) has recently expanded its capacity to provide both functional restoration (FR) and complementary and integrative medicine (CIM) therapies for neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine the most effective treatment combination, sequence, and duration of standard rehabilitative care (SRC), such as physical and occupational therapy in combination with cognitive behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service members preparing to enroll in an intensive FR program that is currently the DoD-recommended treatment. In addition, this study aims to identify ways to predict in advance which patients will respond best to which therapeutic regimens.
Potential Impact. This research has the potential to determine which patients are most likely to benefit from the non-medication pain therapies currently available in all Army Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively be combined to achieve the greatest improvements in pain impact, quality of life and ability to return to duty following injury.
Patients Who Will Benefit. This study will involve active duty Service members referred to an Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans Health Administration (VHA) pain management centers so that active duty Service members and veterans across United States may benefit from a treatment approach that is tailored to their individual characteristics. It is anticipated that the knowledge gained through this research will be applicable to family members of Service members and veterans and will ultimately lead to expansion of TRICARE benefits to include CIM therapies.
Potential Clinical Applications, Benefits, and Risks. This research will assist providers in determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the needs of each patient. Service members and veterans will benefit by being referred for these approaches when appropriate during the course of disabling chronic pain conditions. Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record to guide health care providers to consider referral for these therapies in patients who may benefit. This study will advance our ability to effectively tailor therapies for rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest benefit in physical function and quality of life. The risks of these interventions are minimal; Service members may experience general muscle soreness for the first week or so of increased physical activity, but this typically resolves.
Projected Timeline. This research will determine the optimal combination, sequence, and duration of therapies. It is expected that some active duty Service members could see improvements in function and quality of life within three weeks, but others may require up to six weeks to experience meaningful improvement.
Benefit to Military Personnel. This research will benefit Service members experiencing pain due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies most likely to yield meaningful improvements in function and quality of life, and thus facilitate their return to duty. The recommendations from this study will be shared with pain management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.
Exclusion Criteria:
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Behavioral: Complementary and Integrative Therapies
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Behavioral: Standard Rehabilitative Care
Intervention time period is 3 - 6 weeks.
Intervention time period is 3 - 6 weeks.
Change from Baseline Pain Intensity
Pain Intensity 10-pt Numeric Rating Scale
Time frame: 3 months
Change from Baseline Pain Impact
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: 3 months
Depression
Patient Reported Outcome Measurement Information System
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Anxiety
Patient Reported Outcome Measurement Information System
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Emotional Distress - Anger
Patient Reported Outcome Measurement Information System
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Sleep Disturbance
Patient Reported Outcome Measurement Information System
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Fatigue
Patient Reported Outcome Measurement Information System
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
PTSD
Primary Care PTSD Screen
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Activation Measure
A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Drug Use
Drug Use Questionnaire
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Catastrophizing
Pain Catastrophizing Scale
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Kinesiophobia
Tampa Scale for Kinesiophobia
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Self-Efficacy
Pain Self Efficacy Questionnaire
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Chronic Pain Acceptance
Chronic Pain Acceptance Questionnaire
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Functional Capacity
Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Opioid Utilization
Opioid Utilization Screener
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Cortisol
Salivary Cortisol
Time frame: baseline, 6 weeks
Oxidative Stress
Urine Sample
Time frame: baseline, 6 weeks
Genomic DNA
Buccal Sample
Time frame: baseline
Army Physical Fitness Test (APFT)
Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
Time frame: baseline, 6 weeks, 3 months, 6 months
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of Washington