Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica
Condition: Sciatica
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Sciatica is most often caused by a herniated disc in the lumbar region of the back and
      results from inflammation of the nerve roots as they exit the spine. It is a very common
      cause of back and leg pain, loss of function, and inability to work. Although sciatica is
      common, the effectiveness of current treatments is limited. Epidural steroid injections
      (ESIs), which can reduce inflammation of the nerve roots, are commonly used to decrease
      sciatica pain and restore normal function in patients. The exact effectiveness of ESIs,
      however, is unknown. If inflammation, and not compression, is the main cause of sciatica, it
      is reasonable to consider giving the steroid orally rather than by injection. If oral
      steroids prove effective, patients and clinicians will have access to a simple, inexpensive
      therapy that can be prescribed by primary care physicians without delay. This study will
      determine the effectiveness of the oral steroid prednisone in decreasing pain and improving
      function in people with sciatica.

      Participants in this study will attend a screening visit at which they will answer questions
      about their health to determine eligibility, undergo a neurologic exam, and have a plain
      lower spine x-ray. An MRI of the lower spine will be performed for those who meet clinical
      eligibility. Participants whose MRI shows that a disc has ruptured in a specific way will be
      randomly assigned to receive either a 15-day course of prednisone capsules or a 15-day course
      of placebo capsules. Participants will take their assigned study medications in addition to
      their usual pain medications.

      At Week 3, participants will return for a follow-up visit during which they will answer
      questions about their pain and general health and wellness. Participants who are still having
      considerable pain will be offered an epidural steroid injection (ESI) as a part of the study.
      At Week 6, participants will be called at home for a telephone interview and again answer
      questions about their general health and wellness; this telephone call will last about 20
      minutes. If they continue to have considerable pain, they will be offered a second ESI as
      part of the study.

      At Week 12, an interviewer will phone participants to determine if their pain has decreased
      and whether they have been able to return to their normal activities. The telephone contact
      will last about 20 minutes. Additional information about their back problems will be obtained
      from their medical records and from Kaiser Permanente's computerized medical records on their
      use of health care and medicines for back problems. At Week 24, participants will attend an
      evaluation visit at the Spine Clinic to assess their progress and symptoms. At Week 52 (1
      year from randomization), participants will undergo a final telephone interview.
    

Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Placebo capsules will look the same as the study medication but will not contain active medicine.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Back Pain; Leg Pain