Low Back Pain Clinical Trial
— SOULCSOfficial title:
The Effect of a Brief Pre-operative Pain Medication Educational Video on Post-operative Prescription Opioid Medication Use in Patients Undergoing Spine Surgery. A Randomized Controlled Trial
NCT number | NCT02674711 |
Other study ID # | C.2015.048d |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | June 1, 2018 |
Verified date | July 2022 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 1, 2018 |
Est. primary completion date | February 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center | Baylor University |
United States,
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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. doi: 10.1002/14651858.CD004959.pub3. — View Citation
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. — View Citation
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. doi: 10.2106/JBJS.M.00865. Epub 2014 Jun 4. — View Citation
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. — View Citation
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Rhon DI, Greenlee TA, Mayhew R, Boyer C, Laugesen M, Roth J, Dowd TC, Gill NW. Engaging Education About Risks of Opioid Use With Patients Before Elective Surgery of the Lower Extremity Did Not Reduce Postoperative Opioid Utilization: A Randomized Controll — View Citation
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. — View Citation
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. doi: 10.5055/jom.2007.0050. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Opioid Medication Prescriptions | Number of prescriptions within 12 months after surgery | 12 months | |
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) | 6 months | |
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. | 6 months |
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