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Completed

NCT Number: NCT00934284

Effectiveness Study of Physical Therapy as an Adjunct to a Lumbar Therapeutic Selective Nerve Root Block

The purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica).

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Key information

Conditions

Sciatic Neuropathy Bone Diseases Hernia Intervertebral Disc Displacement Intervertebral Disk Displacement Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Spinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Healthcare

Salt Lake City, Utah, 84107, United States

About this study

Recent reviews report moderate to strong evidence for short-term relief but limited evidence for long-term improvement. Anecdotal reports and case studies suggest good outcomes with various physical therapy interventions however well-designed research studies examining treatments in combination are lacking. The management of lumbar radicular pain often includes the combination of physical therapy and therapeutic selective nerve root blocks with the rationale that reducing inflammation and pain will permit greater participation in physical therapy. The effectiveness of this combination of treatment has not been studied and is the purpose of this pilot study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • MRI evidence of disk herniation in the lumbar spine consistent with clinical presentation
  • Pain and/or paresthesia in the lumbar spine and a distribution extending distal to the gluteal fold within 24 hours of enrollment
  • Scheduled to receive a therapeutic selective nerve root block

Exclusion criteria

  • Any lumbar surgery within six months of the baseline examination
  • Any prior lumbar surgery involving fusion
  • Medical red flags indicating a serious pathology such as neoplasm, infection, or fracture

Treatment and study plan

Lumbar injection

Other

Patients are instructed to resume normal activity as tolerated.

Rehabilitation following lumbar injection

Other

Participants are referred to an average of four weeks of physical therapy after receiving a lumbar injection. Physical therapy designed to include end-range directional preference exercises and/or mechanical traction to reduce lower extremity symptoms and progress activity tolerance.

Primary outcomes

  1. Modified Oswestry Disability Index

    Time frame: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection

Secondary outcomes

  1. Global Rating of Change

    Time frame: 8 weeks (post-injection) and 6 months (post-injection)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Effectiveness of Physical Therapy as an Adjunct to a Selective Nerve Root Block in the Treatment of Lumbar Radicular Pain From Disk Herniation

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 8, 2009
Registry last updated
Dec 13, 2024

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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