Intervertebral Disc Disorder, Low Back Pain, Lumbago, Radiculopathy
Conditions
Keywords
Low Back Pain, Risk-Stratified Care
Brief summary
This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military Health System for patients with low back pain presenting to primary care.
Detailed description
Subjects with low back pain presenting to primary care will be enrolled in a study that aims to evaluate the utility of the SBST for providing risk-stratified care. The concept of this approach revolves around matching treatment to patients based on their risk for developing chronic disability from back pain. Those at low risk receive less treatment, and those at high risk need more specialized treatment, that includes psychosocially-focused and cognitive considerations. This approach will be compared to usual care, where general practitioners carry out the course of action they think best for each patient, without any other guidance. Patients will be followed for 1 year.
Interventions
PROCEDURERisk Stratified Care
Physical therapists providing care will all have attended live training in PIPT principles and be involved in monthly continuing education on these principles. The use of specific principles is guided by the patient's risk stratification (as determined by the STarT Back Tool). Medium Risk: \- Reassurance will be provided to address specific concerns related to their LBP and implications on work High Risk: \- Physical therapy will be psychologically augmented with the assessment of biopsychosocial risk factors and the adoption of cognitive behavioral principles that explore patient concerns and address unhelpful beliefs and behaviors, including tailored education (e.g., stress management and pain neuroscience), graded exercise, \& graded exposure
PROCEDUREUsual Care
Usual care at the general practitioner's discretion
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Primary care providers will be unaware of risk stratification scores.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females who are between the ages of 18-50 years old 2. Primary complaint of LBP for any duration, with or without associated radiculopathy 3. Can speak and understand English 4. Be willing and able to give full, informed written consent
Exclusion criteria
1. Red Flags: Any potentially serious or systemic disorders (e.g., cauda equina compression, inflammatory arthritis, compression fracture, malignancy, infection, severe neurological progression), serious illness or comorbidity 2. Spinal surgery in the past 24 months 3. Current pregnancy (or within the last 6 months) 4. Already receiving treatment (other than primary care) for this episode of LBP 5. Inability to attend regular treatment sessions 6. Pending litigation or a medical evaluation board
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire (RMDQ) | 1 year | The RMDQ measures low back pain related disability by prompting the participant using 24 statements. The score ranges from 0 to 24 with higher scores indicating greater disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System - Pain Interference | 1 year | The PROMIS Pain Interference domain provides a T-score based on the population mean of 50 (standard deviation of 10), with higher scores indicating higher pain interference |
| EuroQoL (EQ-5D) | 1 year | The EQ-5D is a generic quality of life questionnaire lhat assesses quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The tool provides a quality of life scores, which is measured by a utility score with 1 representing perfect health and 0 representing a state considered as bad as being dead. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Rhon, DPT, DSc
Director of Clinical Outcomes Research, Center for the Intrepid
Baseline characteristics
| Characteristic | — |
|---|---|
| Active Duty Service Member | 125 Participants |
| Age, Continuous | 34.7 Years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 58 Participants |
| Race (NIH/OMB) More than one race | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 145 |
| other Total, other adverse events | 59 / 145 | 73 / 145 |
| serious Total, serious adverse events | 0 / 145 | 0 / 145 |
Outcome results
None listed