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Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy

NCT01443819 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-06-30

No results posted yet for this study

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).

Conditions

  • Lumbar Radiculopathy

Interventions

OTHER

Lumbar Transforaminal Epidural Corticosteroid Injection

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.

OTHER

Physical Therapy

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.

OTHER

Observation

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.

Sponsors & Collaborators

Principal Investigators

  • Matthew Smuck, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443819 on ClinicalTrials.gov