Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica

NCT00668434 | Completed Phase 2 Results DMC

• 1 other identifier: R01AR053960
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 3

Brief Summary

Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The condition is caused by injury to or compression of the sciatic nerve, which is located in the back of the leg. This study will determine the effectiveness of the steroid prednisone in decreasing pain and improving function in people with sciatica.

Conditions

Sciatica

Keywords

Back Pain; Leg Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index, v2

  The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.

  Baseline, Week 3 follow-up

Secondary Outcomes (3)

• Pain Numerical Rating Scale

  Baseline, Week 3 follow-up

• Oswestry Disability Index, v2

  Baseline, Week 52 follow-up

• Pain Numerical Rating Scale

  Baseline, Week 52 follow-up

Study Arms (2)

Prednisone

EXPERIMENTAL

Participants will receive a 15-day tapering course of prednisone capsules.

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Participants will receive a 15-day course of placebo capsules.

Drug: Placebo

Interventions

Prednisone DRUG

For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.

Prednisone

Placebo DRUG

Placebo capsules will look the same as the study medication but will not contain active medicine.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville site
• Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution
• Score of at least 20 on the modified Oswestry Disability Index
• Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc
• MRI study confirms a herniated disc consistent with the signs and symptoms

You may not qualify if:

• Onset of sciatica symptoms occurred more than 3 months before study entry
• Cauda equina syndrome
• Active cancer
• Acute spinal fracture
• Currently taking oral steroids
• Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%
• Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg
• Pregnant or breastfeeding
• Active peptic ulcer disease
• History of intolerance to steroid therapy
• Bleeding diathesis or anticoagulant therapy
• Ongoing litigation or workers compensation claim for low back pain or sciatica
• Underwent previous lumbar surgery
• Received epidural steroid injection (ESI) within the 12 months before study entry
• Unable to read or speak English

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

Kaiser Permanente Northern California, Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente

Roseville, California, 95661, United States

Location

Kaiser Permanente Northern California, San Jose

San Jose, California, 94119, United States

Location

Related Publications (1)

• Goldberg H, Firtch W, Tyburski M, Pressman A, Ackerson L, Hamilton L, Smith W, Carver R, Maratukulam A, Won LA, Carragee E, Avins AL. Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial. JAMA. 2015 May 19;313(19):1915-23. doi: 10.1001/jama.2015.4468.

  PMID: 25988461 DERIVED

MeSH Terms

Conditions

Sciatica; Back Pain

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Andrew Avins
• Organization: Kaiser Permanente, Northern California

andy.l.avins@kp.org

510-891-3557

Study Officials

• Harley Goldberg, DO

  Kaiser Permanente San Jose Medical Center

  PRINCIPAL INVESTIGATOR

• Andrew L. Avins, MD, MPH

  Kaiser Permanente Division of Research

  PRINCIPAL INVESTIGATOR

• William Firtch, MD

  Kaiser Permanente Redwood City

  PRINCIPAL INVESTIGATOR

• Mark Tyburski, MD

  Kaiser Permanente, Roseville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: April 28, 2015
• Results First Posted: April 28, 2015

Record last verified: 2015-04

Locations

US (3)