Clinical Trial: The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica. A Randomized Clinical Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica. A Randomized Clinical Controlled Trial

Brief Summary:

This Study si designed as a Prospective clinical controlled randomized trial.

Background:

Reviews have demonstrated no or little efficacy for passive conservative treatment modalities for patients suffering from sciatica. The results of surgery are conflicting. Cohort studies have shown a high efficacy for active treatment modalities in patients with sciatica. The current trend in treatment of low back pain without sciatica is focusing on active conservative treatment like information and advice to stay active and exercises.

Aim: To evaluate the efficacy of two active conservative treatment programs for patients with severe sciatica.

Methods: In a prospective clinical controlled randomized trial, 181 consecutive patients with radicular pain below the knee were examined at baseline, 8 weeks later at post treatment follow-up, and at one year follow-up and MR-scanned at baseline and one year follow-up. The treatment consisted of four elements: 1-3 were identical in both groups. 1. Thorough information concerning anatomy, pathogenesis, how discs heal without surgery, and encouragement to stay as active as possible but to reduce activity if an increase in leg pain occurs. 2." Tender love and care". 3. Medication; this was optional and only weak analgesic and NSAIDs were recommended.

Element 4 consisted of two different exercise programs. Symptom guided exercises consisted of a variety of back related exercises and optional manual treatment. The exercises were given after an algorithm, where different symptoms or a response to exercises determined the exercises given. The other group, Sham exercises had voluntary not back related exercises. The exercises were aimed at inc

Detailed Summary:

Summary of Background Data. Sciatica as a result of a herniated disk is a fairly common problem; studies have shown a life time prevalence of 4-5 % in the Scandinavian population. Though a herniated disk is a benign disease with a relatively good prognosis, the pain and functional loss, are in most patients rather considerable over a period of some months Reviews have demonstrated no or little efficacy for passive conservative treatment modalities. Results for surgery are conflicting. Cohort studies have shown a high efficacy for active treatment modalities in patients with sciatica.

The current trend in back treatment is information and advice to stay active including active treatment modalities in which patients are given responsibility during the treatment process and the treatment assumes the role of a "coach".

Objectives. To evaluate the efficacy of two active conservative treatment programs for patients with severe sciatica.

Methods A prospective clinical controlled randomized trial including 181 consecutive patients with radicular pain below the knee. The patients were examined at baseline, 8 weeks later at post treatment follow-up, and, and MR-scanned at baseline and at the one year follow-up The treatment consisted of four elements; 1-3 were identical in both groups. 1. Thorough information concerning anatomy, pathogenesis, how discs heal without surgery, and encouragement to stay as active as possible but to reduce activity if an increase in leg pain occurs. 2. Tender love and care. 3. Medication, this was optional and only weak analgesic and NSAID'S were recommended.

Element 4 was divided into a "Hands on" and "Hands off", utilizing two different exercise programs. "Hands on"
Sponsor: The Back Research Center, Denmark

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Back Research Center, Denmark

Dates:
Date Received: October 31, 2005
Date Started: November 2001
Date Completion: August 2003
Last Updated: October 16, 2008
Last Verified: October 2005