Low Back Pain, Neck Pain, Opiate Addiction
Conditions
Keywords
patient education, low back pain, post-surgical pain, chronic opioid use, Neck Pain
Brief summary
The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.
Detailed description
After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon. Education Group: The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage. All Subjects: All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon. All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted, and then again at 6 months to ask history of prescription opioid utilization.
Interventions
BEHAVIORALEducational Video
The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long.
Sponsors
Baylor University
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery. 2. Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic) 3. Between the age of 18 - 65 years 4. Read and speak English well enough to understand the education, provide informed consent and follow study instructions
Exclusion criteria
a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Opioid Medication Prescriptions | 12 months | Number of prescriptions within 12 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI) | 6 months | The ODI and NDI are 10-item scales with higher numbers indicating greater disability. Each item has 6 possible questions (0-5), which are then summed and multiplied to provide a % score out of 100%. The ODI focused on low back pain and the NDI on neck pain. As values are on the same scale, they were entered as one outcome since we included both neck and low back pain patients. Patients undergoing cervical spine surgery filled out the NDI (Neck Disability Index) and patients undergoing lumbar spine surgery filled out the ODI (Oswestry Disability Index) |
| Numeric Pain Rating Scale (NPRS) | 6 months | A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess pain intensity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Video Evidence-based video: Best Advice for People Taking Opioid Medication
Educational Video: The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long. | 60 |
| Usual Care Usual care education provided at time of pre-operative appointment. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Usual Care | Total | Educational Video |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 10.4 | 46.1 years STANDARD_DEVIATION 10.7 | 46.6 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) Other American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Other Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Other Black or African American | 12 Participants | 26 Participants | 14 Participants |
| Race (NIH/OMB) Other More than one race | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) Other Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Other Unknown or Not Reported | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) Other White | 34 Participants | 64 Participants | 30 Participants |
| Sex: Female, Male Female | 16 Participants | 40 Participants | 24 Participants |
| Sex: Female, Male Male | 44 Participants | 80 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Number of Opioid Medication Prescriptions
Number of prescriptions within 12 months after surgery
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Educational Video | Number of Opioid Medication Prescriptions | 5.0 prescriptions count |
| Usual Care | Number of Opioid Medication Prescriptions | 5.1 prescriptions count |
Secondary
Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)
The ODI and NDI are 10-item scales with higher numbers indicating greater disability. Each item has 6 possible questions (0-5), which are then summed and multiplied to provide a % score out of 100%. The ODI focused on low back pain and the NDI on neck pain. As values are on the same scale, they were entered as one outcome since we included both neck and low back pain patients. Patients undergoing cervical spine surgery filled out the NDI (Neck Disability Index) and patients undergoing lumbar spine surgery filled out the ODI (Oswestry Disability Index)
Time frame: 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Educational Video | Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI) | 41.7 score on a scale |
| Usual Care | Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI) | 37.8 score on a scale |
Secondary
Numeric Pain Rating Scale (NPRS)
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess pain intensity.
Time frame: 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Educational Video | Numeric Pain Rating Scale (NPRS) | 5.7 score on a scale |
| Usual Care | Numeric Pain Rating Scale (NPRS) | 5.1 score on a scale |