Trial Outcomes & Findings for Study of Opioid Use After Lumbar and Cervical Spine Surgery (NCT NCT02674711)

NCT ID: NCT02674711

Last Updated: 2023-05-19

Results Overview

Number of prescriptions within 12 months after surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-05-19

Participant Flow

Participant milestones

Measure	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.	Usual Care Usual care education provided at time of pre-operative appointment.
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Opioid Use After Lumbar and Cervical Spine Surgery

Baseline characteristics by cohort

Measure	Educational Video n=60 Participants 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.	Usual Care n=60 Participants Usual care education provided at time of pre-operative appointment.	Total n=120 Participants Total of all reporting groups
Age, Continuous	46.6 years STANDARD_DEVIATION 11.0 • n=5 Participants	45.5 years STANDARD_DEVIATION 10.4 • n=7 Participants	46.1 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	16 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	44 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) Other · American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Other · Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Other · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Other · Black or African American	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) Other · White	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) Other · More than one race	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Other · Unknown or Not Reported	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of prescriptions within 12 months after surgery

Outcome measures

Measure	Educational Video n=60 Participants 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.	Usual Care n=60 Participants Usual care education provided at time of pre-operative appointment.
Number of Opioid Medication Prescriptions	5.0 prescriptions count Interval 3.8 to 6.7	5.1 prescriptions count Interval 3.7 to 7.1

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Educational Video n=60 Participants 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.	Usual Care n=60 Participants Usual care education provided at time of pre-operative appointment.
Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)	41.7 score on a scale Interval 36.6 to 42.6	37.8 score on a scale Interval 33.0 to 42.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Educational Video n=60 Participants 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.	Usual Care n=60 Participants Usual care education provided at time of pre-operative appointment.
Numeric Pain Rating Scale (NPRS)	5.7 score on a scale Interval 5.0 to 6.5	5.1 score on a scale Interval 4.4 to 5.8

Adverse Events

Educational Video

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Educational Video n=60 participants at risk 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.	Usual Care n=60 participants at risk Usual care education provided at time of pre-operative appointment.
General disorders death	0.00% 0/60 • 6 months	0.00% 0/60 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr Dan Rhon

Brooke Army Medical Center

Phone: 210-916-3303

Email: daniel.i.rhon.ctr@mail.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place