SOULCS: Study of Opioid Use After Lumbar and Cervical Spine Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 whiteboard 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Educational Video Evidence-based video: Best Advice for People Taking Opioid Medication |
Behavioral: 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.
Other Names:
|
| No Intervention: Usual Care Usual care education provided at time of pre-operative appointment. |
Outcome Measures
Primary Outcome Measures
- Number of Opioid Medication Prescriptions [6 months]
Number of prescriptions within 6 months after surgery
Secondary Outcome Measures
- Modified Oswestry Disability Index (ODI) [6 months]
The ODI is a 10-item scale 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%.
- 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.
- Pain Catastrophizing Scale (PCS) [6 months]
The PCS is a 13-item patient-report scale developed to measure the extent to which people catastrophize in response to pain. Each item is scored from 0 ('not at all') to 4 ('all the time'). The PCS is reported as a total score, with higher scores indicating greater catastrophizing, and is composed of three sub-scales: Rumination, Magnification, and Helplessness.
- Fear Avoidance Beliefs Questionnaire (FABQ) [6 months]
The FABQ will be used to measure patients' beliefs about how physical activity and work may affect their pain and perceived risk for re-injury. The FABQ contains two subscales; a 7-item work subscale (FABQW), and 4-item physical activity subscale (FABQPA). Higher scores represent higher levels of fear avoidance beliefs.
- Pittsburgh Sleep Quality Index (PSQI) [6 months]
The Pittsburgh Sleep Quality Index (PSQI) measures the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Higher scores indicate greater sleep impairment.
- Neck Disability Index [6 months]
The NDI was created to measure pain related disability associated with activities of daily living in people with neck pain. Each item is scored on a 6-point scale and can reach a maximum score of 5; therefore, the maximum score is 50. Higher scores indicating higher levels of disability. Content, construct validity and reliability of the NDI has been previously shown in patients with neck pain. The MCID has been established as a change of 13% (or 6.5 points).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.
-
Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
-
Between the age of 18 - 65 years
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Read and speak English well enough to understand the education, provide informed consent and follow study instructions
Exclusion Criteria:
- Known aversion or allergy that would prevent the patient from taking any opioid based pain medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brooke Army Medical Center | San Antonio | Texas | United States | 78234 |
Sponsors and Collaborators
- Brooke Army Medical Center
- Baylor University
Investigators
- Principal Investigator: Daniel Rhon, DPT, DSc, Brooke Army Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009 Feb;10(2):147-59. doi: 10.1016/j.jpain.2008.10.007. Review.
- Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004959. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD004959.
- Devin CJ, Lee DS, Armaghani SJ, Bible J, Shau DN, Martin PR, Ehrenfeld JM. Approach to pain management in chronic opioid users undergoing orthopaedic surgery. J Am Acad Orthop Surg. 2014 Oct;22(10):614-22. doi: 10.5435/JAAOS-22-10-614. Review.
- Lee D, Armaghani S, Archer KR, Bible J, Shau D, Kay H, Zhang C, McGirt MJ, Devin C. Preoperative Opioid Use as a Predictor of Adverse Postoperative Self-Reported Outcomes in Patients Undergoing Spine Surgery. J Bone Joint Surg Am. 2014 Jun 4;96(11):e89. Epub 2014 Jun 4.
- Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJ, Fellows B, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm S 2nd, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Silverman SM, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician. 2012 Jul;15(3 Suppl):S67-116.
- Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007 Jan 16;146(2):116-27. Review.
- Trescot AM, Boswell MV, Atluri SL, Hansen HC, Deer TR, Abdi S, Jasper JF, Singh V, Jordan AE, Johnson BW, Cicala RS, Dunbar EE, Helm S 2nd, Varley KG, Suchdev PK, Swicegood JR, Calodney AK, Ogoke BA, Minore WS, Manchikanti L. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006 Jan;9(1):1-39. Review.
- Walid MS, Hyer L, Ajjan M, Barth AC, Robinson JS Jr. Prevalence of opioid dependence in spine surgery patients and correlation with length of stay. J Opioid Manag. 2007 May-Jun;3(3):127-8, 130-2.
- C.2015.048d