Study of Opioid Use After Lumbar and Cervical Spine Surgery

NCT02674711 | Completed Results

• 1 other identifier: C.2015.048d
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Opiate Addiction; Neck Pain

Keywords

patient education; low back pain; post-surgical pain; chronic opioid use; Neck Pain

Outcome Measures

Primary Outcomes (1)

• Number of Opioid Medication Prescriptions

  Number of prescriptions within 12 months after surgery

  12 months

Secondary Outcomes (2)

• Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)

  6 months

• Numeric Pain Rating Scale (NPRS)

  6 months

Study Arms (2)

Educational Video

EXPERIMENTAL

Evidence-based video: Best Advice for People Taking Opioid Medication

Behavioral: Educational Video

Usual Care

NO INTERVENTION

Usual care education provided at time of pre-operative appointment.

Interventions

Educational Video BEHAVIORAL

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.

Also known as: Best Advice for People Taking Opioid Medication

Educational Video

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Read and speak English well enough to understand the education, provide informed consent and follow study instructions

You may not qualify if:

• a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• Baylor University: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (9)

• 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.

  PMID: 22786449 BACKGROUND

• 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.

  PMID: 16700278 BACKGROUND

• 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.

  PMID: 25281256 BACKGROUND

• 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.

  PMID: 18027538 BACKGROUND

• 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. doi: 10.7326/0003-4819-146-2-200701160-00006.

  PMID: 17227935 BACKGROUND

• 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.

  PMID: 17636781 BACKGROUND

• 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.

  PMID: 24897746 BACKGROUND

• 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.

  PMID: 19187891 BACKGROUND

• 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 Controlled Trial. J Am Acad Orthop Surg. 2022 Apr 1;30(7):e649-e657. doi: 10.5435/JAAOS-D-21-00603.

  PMID: 35130200 RESULT

MeSH Terms

Conditions

Low Back Pain; Opioid-Related Disorders; Neck Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Dr Dan Rhon
• Organization: Brooke Army Medical Center

daniel.i.rhon.ctr@mail.mil

210-916-3303

Study Officials

• Daniel Rhon, DPT, DSc

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Therapy, Center for the Intrepid

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 4, 2016
• Study Start: August 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: June 1, 2018
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available for 1 year
• Access Criteria: US Defense Health Agency data sharing agreement application approved

Locations

US (1)