search
Back to results

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

Primary Purpose

Back Pain, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care
Individualized Postural Therapy (IPT) + PCP led care
Usual PCP led care
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • HonorHealth Medical Group
  • Marwan A. Edris, MD
  • Teresa S. Sligh, MD
  • Augusto Focil, MD
  • Vanderbilt University Medical Center
  • Carlos R. Herrera, MD
  • Luis Zepeda, MD
  • Bernadette U. Iguh, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual PCP led care

Identify, Coordinated, Enhanced (ICE) Decision Making

Individualized Postural Therapy (IPT)

Arm Description

Outcomes

Primary Outcome Measures

Spine-related cost of care at one year
Measured by patient self-report
Change in pain
Measured by Oswestry Disability Index

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2017
Last Updated
November 14, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT03083886
Brief Title
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure
Acronym
SPINE CARE
Official Title
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2971 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual PCP led care
Arm Type
Active Comparator
Arm Title
Identify, Coordinated, Enhanced (ICE) Decision Making
Arm Type
Experimental
Arm Title
Individualized Postural Therapy (IPT)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care
Intervention Description
Subjects seeking care at a clinic assigned to this arm will receive the ICE care model through referral by their primary care provider. The ICE care model was developed by the Clinical Excellence Research Center at Stanford University based on a review of the peer-reviewed literature for adult subjects with incident neck or back pain less than six weeks in duration who are not using high-dose opioid medications or receiving spine-related long-term disability payments.
Intervention Type
Other
Intervention Name(s)
Individualized Postural Therapy (IPT) + PCP led care
Intervention Description
IPT involves the evaluation of a subject's posture to identify postural and alignment deviations and, based on this, a personalized corrective exercise program is prescribed. This method does involve the use of prescription medications, surgery, or manipulation. A treatment course typically lasts eight sessions over eight weeks. In order to allow for the consistent delivery of this arm of the study at multiple study-sites across the country, IPT will be delivered by The Egoscue Method. Egoscue was founded in 1971 and has 25 clinics worldwide.
Intervention Type
Other
Intervention Name(s)
Usual PCP led care
Intervention Description
Primary care provider will direct patients' care pathway.
Primary Outcome Measure Information:
Title
Spine-related cost of care at one year
Description
Measured by patient self-report
Time Frame
One year
Title
Change in pain
Description
Measured by Oswestry Disability Index
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Change in pain
Description
Measured by Oswestry Disability Index
Time Frame
One year
Title
Quality of life
Description
Measured by EuroQol- 5 Dimension (EQ-5D) questionnaire
Time Frame
One year
Title
Self-efficacy
Description
Measured by scale developed by Lorig et al.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Medical Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Marwan A. Edris, MD
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Teresa S. Sligh, MD
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Augusto Focil, MD
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Carlos R. Herrera, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77013
Country
United States
Facility Name
Luis Zepeda, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77017
Country
United States
Facility Name
Bernadette U. Iguh, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77051
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34688915
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.
Results Reference
derived

Learn more about this trial

Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

We'll reach out to this number within 24 hrs