Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

Not Applicable

Completed

Conditions: Back Pain
Neck Pain

Registration Number: NCT03083886

Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3087

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spine-related Cost of Care at One Year	One year	Measured by patient self-report
Change in Pain	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

Secondary Outcome Measures

Name	Time	Method
Change in Pain	One year	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
Quality of Life (EQ5D-5L VAS Scores)	One year	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.
Self-efficacy	One year	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.

Trial Locations

Locations (8): HonorHealth Medical Group
🇺🇸
Phoenix, Arizona, United States
Marwan A. Edris, MD
🇺🇸
Laguna Hills, California, United States
Teresa S. Sligh, MD
🇺🇸
North Hollywood, California, United States
Augusto Focil, MD
🇺🇸
Oxnard, California, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Carlos R. Herrera, MD
🇺🇸
Houston, Texas, United States
Luis Zepeda, MD
🇺🇸
Houston, Texas, United States
Bernadette U. Iguh, MD
🇺🇸
Houston, Texas, United States
HonorHealth Medical Group
🇺🇸Phoenix, Arizona, United States