Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01443819 |
| Other study ID # |
SU-09232011-8446 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
May 2011 |
| Est. completion date |
February 2013 |
Study information
| Verified date |
June 2022 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this research study is to look at two of the common forms of treatment for
this condition: physical therapy and epidural steroid injection. The investigators are
attempting to evaluate whether or not physical therapy alone, or epidural steroid injections
alone, are effective in treating this condition. The investigators will also try to determine
whether or not one of these treatments is better than the other for the treatment of
herniated discs with nerve injury (radiculopathy).
Description:
1. Potential research participants identified from clinic population.
- 40 subjects will be enrolled in each group (TFESI and PT). An additional 40
subjects will be enrolled into the concurrent observational cohort.
- Appropriate study subjects will be identified upon initiation of care (MD
evaluation and/or physical therapy). They will have pain of less than or equal to
three months 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. They will have focal disc protrusion with correlating
radicular symptoms and possible radicular/neurological deficits. 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 the level of nerve root impingement. Only subjects with
radiculopathy primarily at L5 and/or S1, due to pathology at L4-5 and/or L5-S1 disc
levels will be included. Those with canal and foraminal compromise due to disc
protrusion at L4-5 with L5 > L4 signs and symptoms WILL be included. Those with
predominantly degenerative stenosis, degenerative spondylolisthesis, or
spondylolysis will be excluded.
Subjects also need to have an eleven point Likert pain scale score greater than or equal
to four. They will not have a history of prior epidural steroid injections within the
prior year or prior lumbar surgery.
2. Initial evaluation and study eligibility determination.
3. Presentation of study to patient and informed consent obtained
4. Baseline pain and outcome measures evaluation (VAS, SF-36, ODI, GPC, PSAQ, physical
exam, work history, analgesic use log, and ancillary treatment log, lost productivity).
-Upon entry to the study, baseline measurements of the patient's pain and function will
be established. The primary outcome measure for this study will be reduction in pain as
measured by a three day average Visual Analog Scale (VAS). Secondary measures will
include: Oswestry Disability Index (ODI), SF-36, a seven point Global Perception of
Change (GPC), a three question Patient Specific Activity questionnaire (PSAQ) (each
patient will list 3 cardinal activities of daily living that are restricted or rendered
impossible because of their pain and will score each item), and utilization of
analgesic, outside medical care, and surgical options, as well as physician physical
exam test parameters and lost productivity.
5. Randomization to TFESI or PT group, if subject declines then inquire about enrolment in
the observational cohort. Participants in this group (Cohort) will chose their treatment
(per-protocol physical therapy, injections, or both) after consulting with their
physicians.
6. Injection: Anesthetic/corticosteroid (per randomization); repeat 1-3 times if clinically
indicated.
The following drugs will be used for this procedure: 80mg Depo-Medrol and 1% lidocaine.
These drugs used for the epidural injections are local anesthetic numbing medicines and
cortisone/steroid anti-inflammatory medicines.
7. Physical therapy carried out per protocol; 2-3 times per week for a total of 12
treatment sessions (excluding initial evaluation, including exit evaluation, minimum
attendance 8/12) to be completed by 6 weeks from initiation of care (within study).
Please note: There will be another PT evaluation at the end of 6 weeks.
8. MD visit at intake evaluation, 4 weeks, 12 weeks,6 months, 12 months (additional phone
contact or prn follow up will be logged as additional care)
9. Pain and functional evaluations at: baseline, 4 weeks, 12 weeks, 6 months, 12 months
(VAS, SF-36, ODI, GPC, PSAQ, work history, analgesic use log, lost productivity and
ancillary treatment log).
- At the 4 week follow-up, subjects who are not satisfied with treatment will be
provided the option to cross-over to the alternate treatment group.
Participants in the control group will chose their treatment (per-protocol physical therapy,
injections, or both) after consulting with their physicians.
All of the procedures for this protocol are standard of care.
We will be asking participants if they are willing to be contacted regarding future research
studies that may be of interest to them.
