Clinical trial NCT03083886: Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure
Official title: Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Neck Pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2017-03-20
Enrollment: 2971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back and neck pain are among the leading causes of medical visits, lost productivity and disability. There is an urgent need to identify effective and efficient ways of helping subjects with acute spine pain while guiding practitioners towards high-value care. This trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized clinical trial comparing healthcare spending and clinical outcomes for subjects with spine pain of less than three months' duration, in whom there are no red flag signs or symptoms. Subjects will be randomized to one of three treatment strategies: (1) usual primary care provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify, Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our outcomes of interest will be spine-related healthcare utilization at one year as well as pain and functionality of the study participants.


Eligibility criteria: Inclusion Criteria:

* Patients with back or neck pain of ≤ 3 months' duration. All patients must have spine pain with or without radiation to the extremities or the head
* Age ≥ 18 years
* Willing and able to provide informed consent

Exclusion Criteria:

* Patients with symptoms attributed to the spine but without actual pain in the spine (e.g. those with cervicogenic headache without neck pain)
* Currently pregnant
* Currently receiving disability benefits, worker's compensation, or involved in litigation for a workplace injury
* Currently enrolled in another intervention trial for the management of acute back or neck pain
* Cancer that is metastatic or being actively treated. (i.e chemotherapy, radiation, surgery)
* History of receiving active therapy for back or neck pain in the past 3 months (7+ consecutive days of narcotic use, 6+ sessions of PT, chiropractic care, acupuncture, postural therapy, or other spine therapy delivered by a trained provider)
* History of spine surgery or spine injections/ablation in the past 6 months
* Severe, active psychosis or major depression inhibiting ability to physically participate in intervention
* Red Flag Symptoms (fever, night sweats, unintentional weight loss, bowel or bladder dysfunction, neurologic weakness, history of intravenous drug use)

Primary outcomes:
measure: Spine-related cost of care at one year
timeFrame: One year
measure: Change in pain
timeFrame: Three months
Secondary outcomes:
measure: Change in pain
timeFrame: One year
measure: Quality of life
timeFrame: One year
measure: Self-efficacy
timeFrame: One year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth Medical Group
state: Arizona
city: Laguna Hills
country: United States
facility: Marwan A. Edris, MD
state: California
city: North Hollywood
country: United States
facility: Teresa S. Sligh, MD
state: California
city: Oxnard
country: United States
facility: Augusto Focil, MD
state: California
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Carlos R. Herrera, MD
state: Texas
city: Houston
country: United States
facility: Luis Zepeda, MD
state: Texas
city: Houston
country: United States
facility: Bernadette U. Iguh, MD
state: Texas
Study officials:
affiliation: Brigham and Women's Hospital
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choudhry NK, Fontanet CP, Ghazinouri R, Fifer S, Archer KR, Haff N, Butterworth SW, Deogun H, Block S, Cooper A, Sears E, Goyal P, Coronado RA, Schneider BJ, Hsu E, Milstein A. Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106602. doi: 10.1016/j.cct.2021.106602. Epub 2021 Oct 22.