Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246948
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2005-10-31
Brief Title:
The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica A Randomized Clinical Controlled Trial
Sponsor:
The Back Research Center Denmark
Organization:
The Back Research Center Denmark
Study Overview
Official Title:
The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica A Randomized Clinical Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 NSAIDS were recommended
Element 4 was divided into a Hands on and Hands off utilizing two different exercise programs Hands on consisted of a variety of back related exercises and optional manual treatment The exercises were given after a strict algorithm where different symptoms or a response to exercises determined the exercises given
Hands off exercises were optional and generally not back related They were geared towards increasing general blood circulation and maintaining strength in the extremities
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 NSAIDS were recommended
Element 4 was divided into a Hands on and Hands off utilizing two different exercise programs Hands on consisted of a variety of back related exercises and optional manual treatment The exercises were given after a strict algorithm where different symptoms or a response to exercises determined the exercises given
Hands off exercises were optional and generally not back related They were geared towards increasing general blood circulation and maintaining strength in the extremities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None