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NCT Number: NCT00786981

Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis

Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. It has been reported that patients with LSS over the age of 65 are more likely to undergo spinal surgery than any other condition with an estimated total annual inpatient expense of one billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore operative morbidity and mortality are a particular concern. Functional benefit derived from conservative treatment may increase the health and quality of life for individuals suffering from LSS and avoid or delay the need for surgery in some subjects. As the population continues to age, identifying effective non-surgical treatment options for older patients with LSS is an important research priority. Ultimately, the information gained from this study will help fill a significant void in medical literature regarding non-surgical options for this patient population.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado University, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lumbar spinal stenosis unidentified by MRI or CT scan and interpreted by a radiologist independent of the study. The criteria of Boden et al will be used to define LSS on MRI: non-discogenic loss of signal in the epidural fat with compression of neural tissues.
  • Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
  • Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
  • Rates sitting as a better position with respect to symptom severity compared to standing or walking.
  • Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
  • Individuals with no language barrier, that are cooperative, have transportation to the Spine Center, and who sign an informed consent form.
  • Age greater than or equal to 50 years.

Exclusion criteria

  • Patients with organic brain syndrome or dementia.
  • Severe vascular, pulmonary or coronary artery disease which limits ambulation.
  • Recent myocardial infarction (within last 6 months).
  • Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
  • Previous spinal surgery that included fusion of two or more vertebrae.
  • Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
  • Metastatic cancer.
  • Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.

Treatment and study plan

Epidural steroid injection plus physical therapy

Other

Patients in the ESI+PT Group will be treated additionally with a physical therapy program emphasizing lumbar flexion exercises, aerobic and strength/ conditioning exercises, and manual physical therapy as well as receiving up to 3 epidural steroid injection(s) and educational support using The Back Book.

Epidural steroid injection

Other

Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.

Primary outcomes

  1. The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW).

    Time frame: 10 weeks, 6 months, 12 months

Secondary outcomes

  1. Change in patient-reported pain

    Time frame: 10 weeks, 6 months, 12 months

  2. Change in Functional Limitations

    Time frame: 10 weeks, 6 months, 12 months

  3. Change in psychosocial evaluation

    Time frame: 10 weeks, 6 months, 12 months

  4. Change in patient satisfaction

    Time frame: 10 weeks, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Franklin Pierce University

Other

Collaborators

  • University of Colorado, Denver

Registry information

Official study title

Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2008
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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