Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure (SPINE CARE)

Mass General Brigham

Status: Completed

Conditions: Back Pain; Neck Pain

Treatments: Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care; Other: Usual PCP led care; Other: Individualized Postural Therapy (IPT) + PCP led care

Study type: Interventional

Funder types: Other

Identifiers

NCT03083886

2017P000622

Details and patient eligibility

About

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.

Enrollment: 3,087 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,087 participants in 3 patient groups

Usual PCP led care

Active Comparator group

Treatment:

Other: Usual PCP led care

Identify, Coordinated, Enhanced (ICE) Decision Making

Experimental group

Treatment:

Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care

Individualized Postural Therapy (IPT)

Experimental group

Treatment:

Other: Individualized Postural Therapy (IPT) + PCP led care