Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure
Completed · Not applicable
Conditions studied: Back Pain, Neck Pain
In brief
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.
Key facts
- Study ID
- NCT03083886
- Run by
- Brigham and Women's Hospital
- People needed
- 3087
- Starts
- 2017-06-05
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- HonorHealth Medical Group — Phoenix, Arizona, United States
- Marwan A. Edris, MD — Laguna Hills, California, United States
- Teresa S. Sligh, MD — North Hollywood, California, United States
- Augusto Focil, MD — Oxnard, California, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Carlos R. Herrera, MD — Houston, Texas, United States
- Luis Zepeda, MD — Houston, Texas, United States
- Bernadette U. Iguh, MD — Houston, Texas, United States
Full record on ClinicalTrials.gov
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