Neck Pain Clinical Trial
— SPINE CAREOfficial title:
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
NCT number | NCT03083886 |
Other study ID # | 2017P000622 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2017 |
Est. completion date | June 30, 2021 |
Verified date | November 2022 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Stanford University |
United States,
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 |
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