Carpal Tunnel Surgery Diagnosis and Treatment Trial

This study compared surgical versus multi-modality, non-surgical treatment for patients with carpal tunnel syndrome without denervation. Participants (n = 116) were randomly assigned using computer-generated random allocation stratified by enrollment site, to carpal tunnel surgery (n=57) or to a well-defined, non-surgical treatment (including hand therapy and ultrasound; n=59). Participants were reassessed at 6 weeks, and at 3, 6, 9, and 12 months after randomization. The primary outcome was hand function measured by the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ) at 12 months assessed by research personnel unaware of group assignment. Secondary outcomes included measures of hand or wrist pain intensity and the effect of carpal tunnel syndrome on work and other activities, including days of work lost and days of limited activity. General health-related quality of life was also assessed with the short-form-36 (SF-36) version 2.0. Participant diaries were used to obtain information about additional treatments for carpal tunnel syndrome.

Longitudinal Cohort of Discogenic Pain

This study used a prospective observational cohort design to better define the outcomes of spinal fusion for presumed discogenic pain and to compare them with outcomes of patients who had degenerated discs but no surgery. The primary outcome was the Roland-Morris back disability score at 12 months, and secondary outcomes included current rating of overall pain severity on a numerical scale, back and leg pain bothersomeness measures, the physical function scale of the short-form 36 version 2 questionnaire, use of medications for pain, work status, emergency department visits, hospitalizations, and further surgery. Outcomes were assessed at 3, 6, 9, and 12 months after enrollment. We enrolled 495 patients with discogenic back pain presenting for initial surgical consultation in offices of 16 surgeons. Eighty-six patients (17%) had surgery within 6 months of enrollment. Surgery consisted of instrumented fusion (79%), disc replacement (12%), laminectomy. 

Investigational Vertebroplasty Efficacy and Safety Trial

The goal of INVEST was to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who underwent vertebroplasty had less disability and pain at 1 month than patients who underwent a control intervention.The control intervention was placement of local anesthesia near the fracture, without placement of cement. We recruited 133 patients with painful osteoporotic vertebral compression fractures from US and foreign sites performing the vertebroplasty procedure. Patients completed a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Spine X-rays were obtained at the end of the study (month 12) to determine subsequent fracture rates. Co-primary outcomes were the modified Roland score and pain numerical rating scale at 1 month. Pre-specified secondary outcomes included scores on the Pain Frequency Index and the Pain Bothersomeness Index, the Study of Osteoporotic Fractures–Activities of Daily Living (SOF–ADL) scale, and the European Quality of Life–5 Dimensions (EQ–5D) scale (a generic health-status measure, reflecting mobility, self-care, activity limitations, pain, and psychological distress); the use of opioid medications and the Physical Component Summary (PCS) and Mental Component Summary (MCS) subscales of the self-administered Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. 

Longitudinal Assessment of Imaging and Disability of the Back

The purpose of the LAIDBack study was to examine the natural history of anatomic lumbar spine changes in a cohort of asymptomatic adults. Patients were randomly selected from various clinics at the Veteran’s Affairs (VA) Puget Sound Health System in Seattle, WA. Half of the n=161 subjects were between 35-52 years and half were 53-70 years. Patients with back pain or sciatica in the previous four months that was more than “mildly bothersome” were excluded. Furthermore, patients with histories of back surgery, chymopapain injections, discography, acute lower back trauma, fibromyalgia, peripheral neuropathy, serious comorbidities that might affect 3-year survival, dementia, or contraindications from receiving lumbar MRIs were excluded. 

The data from this project include demographic information (age, sex, race, marital status, education, employment status, smoking status, body mass index), comorbidities, and patient-reported assessments of back pain (pain frequency index, pain bothersomeness index), function (modified Roland scale), depression, and health-related quality of life (SF-12). Patient-reported assessments were collected at baseline and every 4 months for three years. The data also include lumbar spine findings on magnetic resonance imaging (MRI) including disc desiccation, annual tear, loss of disc height, morphology (bulge, protrusion, extrusion), size of morphology, endplate changes, nerve root compression, facet arthropathy, and stenosis. MRIs were conducted as baseline and, for a subset of the cohort (n=123), three years later.

Lumbar Epidural steroid injections for Spinal Stenosis

The LESS study was a double-blind RCT of ESI plus local anesthetic injections versus local anesthetic injections for the treatment of pain associated with lumbar spinal stenosis in older adults. 400 older adults from 16 sites across the nation were recruited. 

Patients with spinal stenosis referred for an ESI were asked if they would like to participate in the LESS trial. Prior to recruitment, the treating physician determined whether the patient was an appropriate candidate for ESI based on history, physical examination and imaging studies. All eligible patients that agreed to participate in the study were randomized into one of the two study arms: to receive steroid plus local anesthetic epidural injection or local anesthetic alone injection. The patients had opportunity to receive up four injections during the study participation: at baseline, 3, 6 and 9 weeks. At baseline demographic, clinical, and disease-history information were assessed and included patient self-report measures of pain, function, fear avoidance, and pain catastrophizing. In addition, patients were asked about their preferences for assignment to the ESI versus the control intervention, and to rate their expectations of pain relief. All medications used for pain were obtained from medical records and confirmed by patients via medication diaries. The primary outcomes were measures of function and pain, including the Roland-Morris Disability Questionnaire and leg pain measure recorded on an 11-point numerical rating scale (NRS). The primary outcome measures were completed at baseline, 3 days, 14 days, 3 weeks, 6 weeks, and 3, 6 and 12 months post-randomization. 

Secondary outcome measures included the Brief Pain Inventory (BPI) Interference scale, the Patient Health Questionnaire (PHQ-8) measure of depression, Generalized Anxiety Disorder (GAD-7) measure, Swiss Spinal Stenosis Questionnaire (SSSQ), and the EQ-5D. These were administered at all follow-up time points with the exception that the SSSQ, BPI, PHQ-8, GAD-7 and EQ-5D were not administered at Days 3 and 14. The secondary outcome measures were collected at baseline, 3 and 6 weeks, 3, 6 and 12 months post-randomization. In addition, at baseline and at three weeks and six weeks post-injection, blood was drawn to measure HbA1c and fasting blood glucose and morning blood cortisol levels to monitor for hyperglycemia and adrenal suppression following steroid administration. Other measures included patient-completed resource utilization questionnaires to collect information on prescription and over-the-counter medication use, medical visits outside the health plan, and other patient burdens and costs during four 3-week periods throughout the 12-month study. Resource use and costs for utilization within each health system were collected through the electronic health information systems. 

The Lumbar Imaging with Reporting of Epidemiology

The overall goal of the LIRE Pragmatic Trial was to perform a large, pragmatic, randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention – of inserting epidemiological benchmarks into lumbar spine imaging reports– at reducing subsequent tests and treatments (including cross-sectional imaging (MR/CT), opioid prescriptions, spinal injections and surgery). This NIH Collaboratory-funded pragmatic clinical trial included 250,401 participants and was conducted at 98 primary care clinics at four healthcare systems across the nation. Inclusion in the trial required that PCPs initiated one of 10 lumbar spine imaging (XR, CT, MR) CPT codes for evaluation of back pain.  The intervention was inserting epidemiologic data into imaging reports using text that varied by imaging modality and patient age bracket.  Intervention deployment was conducted using a stepped-wedge design with 5 randomization waves at the clinic level, spaced 6 months apart.  Outcome data was passively collected via the electronic health record for a period spanning one year prior to index imaging to two years following index imaging. Utilization data include lumbar spine imaging reports, outpatient and inpatient encounters and diagnosis and procedure codes associated with those encounters, and prescriptions.

Seattle Lumbar Imaging Project

The SLIP study was a randomized controlled trial designed to determine if rapid MRI was better than plain radiographs in terms of subsequent outcomes and costs for people with low back pain.6 This was a randomized trial of 380 patients from 4 sites in Seattle, Washington with low back pain for whom lumbar radiographs were ordered by their primary care physicians. Patients were randomly assigned to receive either lumbar MRI or radiographs. The primary outcome of back-related disability (RDQ) and secondary outcomes including the SF-36, preference scores, satisfaction, utilization and cost data (including hospitalizations, spine surgeries, back pain treatments, medications through patient diaries, billing and EMR data) were obtained up to 12 months.