SciaticaNCT00246948
The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica. A Randomized Clinical Controlled Trial
A study testing Active conservative treatment of sciatica in people with Sciatica, run by The Back Research Center, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sciatica
- What is being tested?
- Active conservative treatment of sciatica
- Type of treatment
- Surgery or procedure
- How many people
- 181 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2001to Aug 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This Study si designed as a Prospective clinical controlled randomized trial.
Background:
Read more
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
Read the 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 NSAID'S 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.
- Conditions
- Sciatica
- Being tested
- Active conservative treatment of sciatica
- Keywords
- Physical therapy
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active conservative treatment of sciaticaProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startNov 2001
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 181 participants
Sponsor and investigators
- Lead sponsor
- The Back Research Center, Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Hanne B Albert, Ph.D., Principal investigator, The Back Research Center, Funen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246948
- Sponsor's protocol ID
- VF 20010134
- Status last verified
- Oct 2005
- First submitted
- 31 Oct 2005
- Last updated
- 17 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica. A Randomized Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT00246948
- Acronym / sponsor ID
- VF 20010134
- Conditions
- Sciatica
- Keywords
- Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants
- Lead sponsor
- The Back Research Center, DenmarkUniversity, hospital or other
- Study start
- Nov 2001
- Study completion
- Aug 2003
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 NSAID'S 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active conservative treatment of sciatica | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne B Albert, Ph.D. principal investigator
The Back Research Center, Funen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active conservative treatment of sciatica in people with Sciatica, run by The Back Research Center, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.