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

NCT01443819 | Terminated Phase 3

• 1 other identifier: SU-09232011-8446
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Radiculopathy; Transforaminal; Disc Protrusion

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score

  12months

Study Arms (3)

Lumbar Transforaminal Epidural Corticosteroid Injection

OTHER

Other: Lumbar Transforaminal Epidural Corticosteroid Injection

Physical Therapy

OTHER

Other: Physical Therapy

Cohort observational

OTHER

Other: Observation

Interventions

Lumbar Transforaminal Epidural Corticosteroid Injection OTHER

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.

Lumbar Transforaminal Epidural Corticosteroid Injection

Physical Therapy OTHER

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.

Physical Therapy

Observation OTHER

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.

Cohort observational

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Visual analog score (VAS) or screening Likert pain scale score three day average and present pain of at least four/ten at baseline.
• Age 18 to 64.
• 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.
• Those with canal and foraminal compromise due to disc herniation at L4-5 with L5 \> L4 signs and symptoms WILL be included.

You may not qualify if:

• Litigation.
• Workers compensation.
• Those receiving remuneration for their pain, e.g. disability.
• Back pain greater than leg pain.
• Scoliosis of \> 15 degrees
• Those unable to read English and complete the assessment instruments.
• Spondylolysis, with or without spondylolithesis, degenerative spondylolithesis, or stenosis due primarily to degenerative bony or soft tissue changes.
• Systemic inflammatory arthritis (e.g. rheumatoid, lupus).
• Addictive behaviour, severe clinical depression, or psychotic features.
• Significant lower extremity pathology that effects gait.
• Sustained cervical or thoracic pain that is present at a level \>4/10 on VAS.
• Possible pregnancy or other reason that precludes the use of fluoroscopy.
• Prior lumbar surgery
• Prior epidural steroid injections for treatment of current episode or within the prior year
• Bilateral radicular signs/symptoms (\< 90% laterality of pain intensity or bilateral neurological signs)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Spinal Diagnostics and Treatment Center

Daly City, California, 94015, United States

Location

Comprehensive Spine and Sport

Mill Valley, California, 94941, United States

Location

Stanford University Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement

Interventions

Physical Therapy Modalities; Observation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Methods; Investigative Techniques

Study Officials

• Matthew Smuck, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 30, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (3)