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

NCT00246948 | Completed

• 1 other identifier: VF 20010134
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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 increasing the general blood circulation and maintaining strength in the extremities. Outcome measures were functional status, pain, MRI findings, clinical findings, and history

Conditions

Sciatica

Keywords

Physical therapy

Interventions

Active conservative treatment of sciatica PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Radicular pain of dermatonal nature in one or both legs or below the knee Leg pain \> 3 on the eleven point box scale20 Radiating pain duration between two weeks and one year Age between 18 to 65 years

You may not qualify if:

• \- Cauda equine syndrome Not having Danish as first language Pending workers litigation claims Inability to follow the rehabilitation protocol, due to concomitant disease Previous back surgery Spinal tumors Pregnancy

Sponsors & Collaborators

• The Back Research Center, Denmark: lead

Study Sites (1)

The Back Research Center

Ringe, 5750, Denmark

Location

MeSH Terms

Conditions

Sciatica

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

Study Officials

• Hanne B Albert, Ph.D.

  The Back Research Center, Funen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 1, 2005
• Study Start: November 1, 2001
• Study Completion: August 1, 2003
• Last Updated: October 17, 2008

Record last verified: 2005-10

Locations

DK (1)