NCT03273036

Brief Summary

The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 29, 2017

Last Update Submit

September 1, 2017

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

  • Post-operative morphine consumption

    Post operative 24 hour of morphine consumption in mg

Secondary Outcomes (3)

  • Visual analog score (back and leg) 0-10

    1 day, 2, 6 ,12, 24 weeks

  • Oswestry disability index (ODI

    2, 6 ,12, 24 weeks

  • MacNab scores

    2, 6 ,12, 24 weeks

Study Arms (2)

epidural steroid injection

ACTIVE COMPARATOR

40 mg triamcinolone acetate 1 cc

Drug: 40 mg Triamcinolone acetate 1 cc

placebo injection

PLACEBO COMPARATOR

no injection agent

Drug: Placebos

Interventions

40 mg Triamcinolone acetate 1 ccDRUG

40 mg Triamcinolone acetate 1 cc

epidural steroid injection
PlacebosDRUG

no injected agent

placebo injection

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed

You may not qualify if:

  • Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 6, 2017

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share