Trial Outcomes & Findings for Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure (NCT NCT03083886)
NCT ID: NCT03083886
Last Updated: 2025-09-17
Results Overview
Measured by patient self-report
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3087 participants
Primary outcome timeframe
One year
Results posted on
2025-09-17
Participant Flow
Individuals ≥18 years with neck and/or back pain of ≤3 months' duration were eligible if they presented to one of the 33 participating primary care clinics in the U.S. between June 2017 and March 2020.
This study was randomized at the clinic level. Once clinics were randomized, all patients within that clinic were in that clinic's assigned arm. Patients who consented AND completed baseline questionnaires are included in the primary analytic dataset.
Unit of analysis: Clinics
Participant milestones
| Measure |
Usual PCP Led Care
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
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)
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1035 11
|
871 11
|
1181 11
|
|
Overall Study
Completed Baseline Data
|
992 11
|
829 11
|
1150 11
|
|
Overall Study
COMPLETED
|
940 11
|
750 11
|
1043 11
|
|
Overall Study
NOT COMPLETED
|
95 0
|
121 0
|
138 0
|
Reasons for withdrawal
| Measure |
Usual PCP Led Care
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
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)
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
51
|
73
|
104
|
|
Overall Study
Missing Baseline data
|
43
|
42
|
31
|
|
Overall Study
Investigator terminated
|
1
|
6
|
3
|
Baseline Characteristics
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure
Baseline characteristics by cohort
| Measure |
Usual PCP Led Care
n=992 Participants
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
n=829 Participants
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)
n=1150 Participants
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.
|
Total
n=2971 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 16.0 • n=93 Participants
|
50.9 years
STANDARD_DEVIATION 16.0 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 16.0 • n=27 Participants
|
51.7 years
STANDARD_DEVIATION 16.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
590 Participants
n=93 Participants
|
514 Participants
n=4 Participants
|
688 Participants
n=27 Participants
|
1792 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
402 Participants
n=93 Participants
|
315 Participants
n=4 Participants
|
462 Participants
n=27 Participants
|
1179 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
108 Participants
n=93 Participants
|
131 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
351 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
884 Participants
n=93 Participants
|
698 Participants
n=4 Participants
|
1038 Participants
n=27 Participants
|
2620 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
73 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
202 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
394 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
640 Participants
n=93 Participants
|
598 Participants
n=4 Participants
|
860 Participants
n=27 Participants
|
2098 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
113 Participants
n=93 Participants
|
127 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
357 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: The primary analytic cohort included patients who consented AND completed baseline questionnaires.
Measured by patient self-report
Outcome measures
| Measure |
Usual PCP Led Care
n=992 Participants
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
n=829 Participants
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)
n=1150 Participants
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.
|
|---|---|---|---|
|
Spine-related Cost of Care at One Year
|
1587 dollars
Standard Deviation 5774
|
1448 dollars
Standard Deviation 2756
|
2528 dollars
Standard Deviation 2756
|
PRIMARY outcome
Timeframe: Three monthsPopulation: The analytic cohort included patients who consented AND completed baseline questionnaires.
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
Outcome measures
| Measure |
Usual PCP Led Care
n=992 Participants
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
n=829 Participants
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)
n=1150 Participants
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.
|
|---|---|---|---|
|
Change in Pain
|
-9.4 score on a scale
Standard Deviation 18.3
|
-15.9 score on a scale
Standard Deviation 16.2
|
-13.9 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: One yearPopulation: The analytic cohort included patients who consented AND completed baseline questionnaires.
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
Outcome measures
| Measure |
Usual PCP Led Care
n=992 Participants
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
n=829 Participants
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)
n=1150 Participants
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.
|
|---|---|---|---|
|
Change in Pain
|
-9.2 score on a scale
Standard Deviation 18.9
|
-17.7 score on a scale
Standard Deviation 16.4
|
-16.3 score on a scale
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: One yearPopulation: The analytic cohort included patients who consented AND completed baseline questionnaires.
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.
Outcome measures
| Measure |
Usual PCP Led Care
n=992 Participants
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
n=829 Participants
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)
n=1150 Participants
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.
|
|---|---|---|---|
|
Quality of Life (EQ5D-5L VAS Scores)
|
3.2 score on a scale
Interval 1.8 to 4.5
|
8.9 score on a scale
Interval 7.7 to 10.2
|
10.5 score on a scale
Interval 9.4 to 11.6
|
SECONDARY outcome
Timeframe: One yearPopulation: The analytic cohort included patients who consented AND completed baseline questionnaires.
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.
Outcome measures
| Measure |
Usual PCP Led Care
n=992 Participants
Usual PCP led care: Primary care provider will direct patients' care pathway.
|
Identify, Coordinated, Enhanced (ICE) Decision Making
n=829 Participants
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)
n=1150 Participants
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.
|
|---|---|---|---|
|
Self-efficacy
|
-1.0 score on a scale
Interval -2.3 to 0.3
|
7.4 score on a scale
Interval 6.4 to 8.4
|
6.4 score on a scale
Interval 5.4 to 7.3
|
Adverse Events
Usual PCP Led Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Identify, Coordinated, Enhanced (ICE) Decision Making
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individualized Postural Therapy (IPT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place