Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

Neck Pain Clinical Trial

— SPINE CARE  

Official title:

Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083886
• Other study ID #: 2017P000622
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2971
• Est. completion date: June 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Other:
• Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care
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.
• Individualized Postural Therapy (IPT) + PCP led care
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.
• Usual PCP led care
Primary care provider will direct patients' care pathway.

Locations

Country	Name	City	State
United States	Bernadette U. Iguh, MD	Houston	Texas
United States	Carlos R. Herrera, MD	Houston	Texas
United States	Luis Zepeda, MD	Houston	Texas
United States	Marwan A. Edris, MD	Laguna Hills	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Teresa S. Sligh, MD	North Hollywood	California
United States	Augusto Focil, MD	Oxnard	California
United States	HonorHealth Medical Group	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spine-related cost of care at one year	Measured by patient self-report	One year
Primary	Change in pain	Measured by Oswestry Disability Index	Three months
Secondary	Change in pain	Measured by Oswestry Disability Index	One year
Secondary	Quality of life	Measured by EuroQol- 5 Dimension (EQ-5D) questionnaire	One year
Secondary	Self-efficacy	Measured by scale developed by Lorig et al.	One year