|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01443819 |
|
Date of registration:
|
26/09/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy
|
|
Scientific title:
|
Randomized, Prospective Study of Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy for the Treatment of Subacute Lumbar Radicular Pain Due to Disc Protrusion |
|
Date of first enrolment:
|
May 2011 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01443819 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Matthew Smuck, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Stanford University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Patient inclusion highlights: L4-5 or L5-S1 HNP with leg>back pain; duration < 12 weeks.
1. Low back pain episode less than or equal to 12 weeks in duration, within the current
pain episode. This may be the initial pain episode or the onset of a most recent
episode of pain, preceded by at least a six month pain free interval.
2. Visual analog score (VAS) or screening Likert pain scale score three day average and
present pain of at least four/ten at baseline.
3. Age 18 to 64.
4. Subjects will have focal disc herniation with unilateral radicular/neurological
deficits or correlating radicular symptoms. These radicular symptoms/signs are
defined as pain or paresthesias below the knee, pain reproduction with
straight-leg-raising and/or extension or quadrant maneuvers, and radicular pattern
sensory, reflex or strength changes. These symptoms will be consistent with their
level of nerve root impingement and will primarily involve the L5 and/or S1 roots.
5. Those with canal and foraminal compromise due to disc herniation at L4-5 with L5 > L4
signs and symptoms WILL be included.
Exclusion Criteria:
1. Litigation.
2. Workers compensation.
3. Those receiving remuneration for their pain, e.g. disability.
4. Back pain greater than leg pain.
5. Scoliosis of > 15 degrees
6. Those unable to read English and complete the assessment instruments.
7. Spondylolysis, with or without spondylolithesis, degenerative spondylolithesis, or
stenosis due primarily to degenerative bony or soft tissue changes.
8. Systemic inflammatory arthritis (e.g. rheumatoid, lupus).
9. Addictive behaviour, severe clinical depression, or psychotic features.
10. Significant lower extremity pathology that effects gait.
11. Sustained cervical or thoracic pain that is present at a level >4/10 on VAS.
12. Possible pregnancy or other reason that precludes the use of fluoroscopy.
13. Prior lumbar surgery
14. Prior epidural steroid injections for treatment of current episode or within the
prior year
15. Bilateral radicular signs/symptoms (< 90% laterality of pain intensity or bilateral
neurological signs)
16. No more than 4 PT sessions for current episode
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Lumbar Radiculopathy
|
|
Intervention(s)
|
|
Other: Lumbar Transforaminal Epidural Corticosteroid Injection
|
|
Other: Observation
|
|
Other: Physical Therapy
|
|
Primary Outcome(s)
|
|
Visual Analog Score
[Time Frame: 12months]
|
|
Secondary ID(s)
|
|
SU-09232011-8446
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|