Comparison of the Order of Treatment in Lumbar Spinal Stenosis

NCT02103543 | Withdrawn DMC

• 1 other identifier: IRB00061868
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Both treatments are usually helpful in patients with back pain with spinal stenosis. However, physicians and other healthcare providers don't know which treatment is better to give first. The purpose of this research is to answer that question. Patients enrolled in this study will receive both treatments: physical therapy (PT) and a steroid injection ("shot"). However, patients may get the shot first followed by PT, or they may have PT first, followed by the shot. Their time in this study will last up to 6 months, and there will be five outcome measurements (via visits or telephone). All study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization computer program.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Oswestry disability Index

  measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year

  1 year

Secondary Outcomes (1)

• visual analog scale

  1 year

Study Arms (2)

Physical Therapy first

ACTIVE COMPARATOR

patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection

Other: physical therapy; Procedure: lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection

lumbar epidural steroid first

ACTIVE COMPARATOR

lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions

Other: physical therapy; Procedure: lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection

Interventions

physical therapy OTHER

physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions

Physical Therapy first; lumbar epidural steroid first

lumbar interlaminar epidural steroid injection PROCEDURE

single lumbar interlaminar epidural steroid injection

Physical Therapy first; lumbar epidural steroid first

epidural steroid injection DRUG

Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)

Physical Therapy first; lumbar epidural steroid first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• history of lumbar surgery, acute disc herniation as reported on a radiologic imaging report, acute or severe chronic illness that are unstable, cognitive impairment which prevents the patient from providing accurate data or giving informed consent, neurological conditions (e.g. stroke, Parkinson's, brain injury), lower extremity amputees, fibromyalgia or chronic generalized pain, unstable opioid use or any signs or evidence of alcohol dependence or illicit drug use (as determined by screening questionnaire), clinical suspicion of facet joint-originating back pain or a positive response to prior facet joint block, lumbar epidural steroid injections within the last 6 months, uncontrolled psychiatric disorders, serious concomitant medical illness (e.g. acute heart failure, acute renal failure) or severe pain that may impair patient's ability to participate in physical therapy exercises or pain that is deemed so severe such that withholding of an ESI until after completion of the PT exercises is seen as causing unreasonable suffering to the patient, and conditions that would prevent the patient from undergoing fluoroscopy (e.g. pregnancy).

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Atlanta Veterans Affairs Medical Center

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Hassan Monfared, MD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Program Director

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 4, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)