Back PainSPINE CARENCT03083886
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure
A study testing Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care, Individualized Postural Therapy (IPT) + PCP led care and Usual PCP led care in people with Back Pain and Neck Pain, run by Brigham and Women's Hospital at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care, Individualized Postural Therapy (IPT) + PCP led care and Usual PCP led care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,087 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Jun 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Carlos R. Herrera, MD
Houston, Texas, 77013
Luis Zepeda, MD
Houston, Texas, 77017
Bernadette U. Iguh, MD
Houston, Texas, 77051
Marwan A. Edris, MD
Laguna Hills, California, 92653
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Teresa S. Sligh, MD
North Hollywood, California, 91606
Augusto Focil, MD
Oxnard, California, 93030
HonorHealth Medical Group
Phoenix, Arizona, 85255
About this study
Official title: Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
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.
- Being tested
- Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care, Individualized Postural Therapy (IPT) + PCP led care, Usual PCP led care
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led careOther
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 careOther
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 careOther
Primary care provider will direct patients' care pathway.
| Study group | Role | What they receive |
|---|---|---|
| Usual PCP led care | Active comparator | Not described Receives: Other: Usual PCP led care |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Experimental | Not described Receives: Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care |
| Individualized Postural Therapy (IPT) | Experimental | Not described Receives: Other: Individualized Postural Therapy (IPT) + PCP led care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spine-related Cost of Care at One Year
Measured by patient self-report
Measured: One year
Change in Pain
Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report.
The ODI ranges from 0 (best) to 100 (worst). The Minimal clinically important difference (MCID) for ODI in patients with spine pain is 6 points.
The change in participant-level pain related disability from baseline to 3 months using the Oswestry Disability Index has been reported.
Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273
Measured: Three months
Secondary outcomes (3)
Change in Pain
Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report.
The ODI ranges from 0 (best) to 100 (worst). The MCID for ODI in patients with spine pain is 6 points.
The change in participant-level pain related disability from baseline to 12 months using the Oswestry Disability Index has been reported.
Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273
Measured: One year
Quality of Life (EQ5D-5L VAS Scores)
EuroQol 5-Dimensional Visual Analogue Scale (EQ-5D-5L VAS) by the EuroQol Group measures patient's self-rated health-related quality of life on a vertical visual analog scale.
EQ-5D-5L VAS range from 0 to 100, with 100 indicating the best score. The MCID for the EQ-5D-5L visual analogue scale ranges from 5.3 to 10.5.
The health-related quality of life at 12 months using the EQ-5D-5L VAS has been reported.
Measured: One year
Self-efficacy
The Lorig self-efficacy functioning sub-scale items ask individuals how confident they are in performing certain daily activities.
Lorig self-efficacy functioning sub-scale scores range from 0 to 100, with 100 indicating the best score. The MCID for the Lorig self-efficacy scale has not been established.
The patient-reported self-efficacy at 12 months using the Lorig self-efficacy functioning sub-scale has been reported.
Reference: Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. PMID: 2912463.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start5 Jun 2017
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Niteesh K Choudhry, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083886
- Sponsor's protocol ID
- 2017P000622
- Acronym
- SPINE CARE
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2017
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choudhry NK, Fifer S, Fontanet CP, Archer KR, Sears E, Bhatkhande G, Haff N, Ghazinouri R, Coronado RA, Schneider BJ, Butterworth SW, Deogun H, Cooper A, Hsu E, Block S, Davidson CA, Shackelford CE, Goyal P, Milstein A; SPINE CARE Investigators; Crum K, Scott J, Marton K, Silva FM, Obeidalla S, Robinette PE, Lorenzana-DeWitt M, Bair CA, Sadun HJ, Goldfield N, Hogewood LM, Sterling EK, Pickney C, Koltun-Baker EJ, Swehla A, Ravikumar V, Malhotra S, Finney ST, Holliday L, Moolman KC, Coleman-Dockery S, Patel IB, Angel FB, Green JK, Mitchell K, McBean MR, Ghaffar M, Ermini SR, Carr AL, MacDonald J. Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2334-2344. doi: 10.1001/jama.2022.22625.
PubMed 36538309Choudhry 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.
PubMed 34688915
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03083886
- Acronym / sponsor ID
- SPINE CARE / 2017P000622
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,087 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual PCP led care | Active comparator | Other: Usual PCP led care |
| Identify, Coordinated, Enhanced (ICE) Decision Making | Experimental | Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care |
| Individualized Postural Therapy (IPT) | Experimental | Other: Individualized Postural Therapy (IPT) + PCP led care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led careSubjects 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. | Other | Identify, Coordinated, Enhanced (ICE) Decision Making |
| Individualized Postural Therapy (IPT) + PCP led careIPT 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. | Other | Individualized Postural Therapy (IPT) |
| Usual PCP led carePrimary care provider will direct patients' care pathway. | Other | Usual PCP led care |
Primary outcome
Spine-related Cost of Care at One Year
Time frame: One year
Measured by patient self-report
Change in Pain
Time frame: Three months
Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The Minimal clinically important difference (MCID) for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 3 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273
3 secondary outcomes
Change in Pain
Time frame: One year
Quality of Life (EQ5D-5L VAS Scores)
Time frame: One year
Self-efficacy
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36538309Choudhry NK, Fifer S, Fontanet CP, Archer KR, Sears E, Bhatkhande G, Haff N, Ghazinouri R, Coronado RA, Schneider BJ, Butterworth SW, Deogun H, Cooper A, Hsu E, Block S, Davidson CA, Shackelford CE, Goyal P, Milstein A; SPINE CARE Investigators; Crum K, Scott J, Marton K, Silva FM, Obeidalla S, Robinette PE, Lorenzana-DeWitt M, Bair CA, Sadun HJ, Goldfield N, Hogewood LM, Sterling EK, Pickney C, Koltun-Baker EJ, Swehla A, Ravikumar V, Malhotra S, Finney ST, Holliday L, Moolman KC, Coleman-Dockery S, Patel IB, Angel FB, Green JK, Mitchell K, McBean MR, Ghaffar M, Ermini SR, Carr AL, MacDonald J. Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2334-2344. doi: 10.1001/jama.2022.22625.
- Derived from this study: PubMed 34688915Choudhry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niteesh K Choudhry, MD, PhD principal investigator
Brigham and Women's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care, Individualized Postural Therapy (IPT) + PCP led care and Usual PCP led care in people with Back Pain and Neck Pain, run by Brigham and Women's Hospital at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spine-related Cost of Care at One Year (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.