Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

Not Applicable

Completed

• Conditions: Back Pain; Neck Pain
• Interventions: Other: Usual PCP led care; Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care; Other: Individualized Postural Therapy (IPT) + PCP led care

• Registration Number: NCT03083886
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Study Start: 2017-06-05
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2971

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual PCP led care	Usual PCP led care	-
Identify, Coordinated, Enhanced (ICE) Decision Making	Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care	-
Individualized Postural Therapy (IPT)	Individualized Postural Therapy (IPT) + PCP led care	-

Primary Outcome Measures

Name	Time	Method
Spine-related cost of care at one year	One year	Measured by patient self-report
Change in pain	Three months	Measured by Oswestry Disability Index

Secondary Outcome Measures

Name	Time	Method
Quality of life	One year	Measured by EuroQol- 5 Dimension (EQ-5D) questionnaire
Self-efficacy	One year	Measured by scale developed by Lorig et al.
Change in pain	One year	Measured by Oswestry Disability Index

Trial Locations

Locations (8)

Marwan A. Edris, MD; 🇺🇸 Laguna Hills, California, United States

HonorHealth Medical Group; 🇺🇸 Phoenix, Arizona, 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