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Randomized Controlled Trial
. 2022 Dec 20;328(23):2334-2344.
doi: 10.1001/jama.2022.22625.

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

Niteesh K Choudhry  1   2 , Sheila Fifer  3 , Constance P Fontanet  1   2 , Kristin R Archer  4   5 , Ellen Sears  1   2 , Gauri Bhatkhande  1   2 , Nancy Haff  1   2 , Roya Ghazinouri  1   2 , Rogelio A Coronado  4   5 , Byron J Schneider  6 , Susan W Butterworth  7 , Harvinder Deogun  8 , Angelina Cooper  8 , Eugene Hsu  3 , Shannon Block  4   5 , Claudia A Davidson  4 , Claude E Shackelford  9 , Parul Goyal  9 , Arnold Milstein  3 ; SPINE CARE Investigators; Katherine Crum  1   2 , Jennifer Scott  3 , Keith Marton  3 , Flavio M Silva  4 , Sarah Obeidalla  4 , Payton E Robinette  4 , Mario Lorenzana-DeWitt  4 , Courtney A Bair  4 , Hana J Sadun  4 , Natalie Goldfield  4 , Luke M Hogewood  4 , Emma K Sterling  4 , Cole Pickney  4 , Emma J Koltun-Baker  4 , Andrew Swehla  4 , Vishvaas Ravikumar  4 , Sameeksha Malhotra  4 , Sabrina T Finney  9 , Lynn Holliday  9 , Karin C Moolman  9 , Shanita Coleman-Dockery  9 , Ilaben B Patel  9 , Federica B Angel  9 , Jennifer K Green  9 , Kevin Mitchell  9 , Mary R McBean  9 , Muteeb Ghaffar  9 , Sandra R Ermini  9 , Ana L Carr  9 , James MacDonald  9
Affiliations
Randomized Controlled Trial

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

Niteesh K Choudhry et al. JAMA. .

Abstract

Importance: Low back and neck pain are often self-limited, but health care spending remains high.

Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain.

Design, setting, and participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021).

Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150).

Main outcomes and measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance.

Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT.

Conclusions and relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year.

Trial registration: ClinicalTrials.gov Identifier: NCT03083886.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Choudhry reported receiving grants from Stanford University during the conduct of the study. Dr Fifer reported receiving grants from Stanford University during the conduct of the study. Dr Archer reported receiving grants from Stanford during the conduct of the study; receiving personal fees from Spine and NeuroSpinal Innovation Inc outside the submitted work; and being a past consultant for Pacira and NeuroPoint Alliance. Dr Haff reported receiving grants from Stanford University to Brigham and Women’s Hospital during the conduct of the study. Dr Schneider reported receiving grants from VUMC during the conduct of the study; receiving grants from Spine Intervention Society and personal fees from State Farm and AIM Specialty outside the submitted work; and serving as a board member of the Spine Intervention Society. Dr Butterworth reported receiving personal fees from Stanford University during the conduct of the study and receiving personal fees for motivational interviewing training from UPMC Health Plan, University of Michigan School of Nursing, PacificSource Health Plan, Independence Care System, Purchaser Business Group on Health, University of Utah, and RGA outside the submitted work. Dr Cooper reported receiving grants from HonorHealth Research Institute during the conduct of the study. Dr Hsu reported full-time employment with Elevance Health (formerly Anthem Inc), a national health insurance organization, as regional vice president, Medicare. Ms Davidson reported receiving grants from Vanderbilt University Medical Center during the conduct of the study. Dr Milstein reported investment in EZPT, a consumer wellness company, outside the submitted work and funding from unrestricted philanthropic gifts to his employer, Stanford University. Dr Crum reported receiving grants from Stanford University during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participants Evaluated, Excluded, Randomized, and Analyzed in the SPINE CARE Trial
SPINE CARE indicates Spine Pain Intervention to Enhance Care Quality and Reduce Expenditure.
Figure 2.
Figure 2.. Baseline, 3-Month Follow-up, and Change in Oswestry Disability Index Score at 3 Months Among Participants With Acute and Subacute Back and Neck Pain
ICE indicates identify, coordinate, and enhance; IPT, individualized postural therapy; and ODI, Oswestry Disability Index. A, Each vertical line represents an individual participant, with participants ordered by baseline value and the vertical line extending up (deterioration) or down (improvement) to the 3-month value. B, Vertical lines extending down denote the degree of improvement in ODI score at 3-month follow-up. Vertical lines extending up denote the degree of decline in ODI score. C, Each box ranges from the 25th (top) to 75th (bottom) percentile of the distribution with the black horizontal line signifying the median. The whiskers extend to the furthest points that are within the 1.5 × IQR of the box (the upper and lower adjacent values). The solid circles beyond the whiskers represent more extreme values.
Figure 3.
Figure 3.. Total Spine-Related Health Care Spending at 12 Months Among Participants With Acute and Subacute Back and Neck Pain
ICE indicates identify, coordinate, and enhance; and IPT, individualized postural therapy. A, Each vertical line represents the cumulative spine-related over 12 months of follow-up for each participant. Values are winsorized at the 95th percentile for the graphical representation. This 95th percentile threshold was $5837 and winsorization was done for 31 patients in the ICE group, 68 patients in the IPT group, and 49 patients in the usual care group. B, Each box ranges from the 25th (top) to 75th (bottom) percentile of the distribution with the black horizontal line signifying the median. The whiskers extend to the furthest points that are within the 1.5 × IQR of the box (the upper and lower adjacent values). The solid circles beyond the whiskers are outliers. Values are winsorized at the 95 percentile for the graphical representation.
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