Low Back PainPhase 4NCT00294229
Spinal Manipulative Therapy for Low Back Pain
A Phase 4 study testing manipulative therapy in people with Low Back Pain, run by University of Bern at 1 site in Switzerland.
Trial summary
Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- manipulative therapy
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2003to Oct 2006
- Phase
- Phase 4
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 55 years
- Duration of acute low back pain less than 4 weeks
- Informed consent
Who cannot join
- Pregnancy
- Radicular origin of back pain (with irradiation)
- Cauda equine syndrome
- Neurologic deficit
- Epidural glucocorticoid injections in the preceding three months
- Previous low back surgery
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- Severe osteoporosis
- Blood-coagulation disorder
- Allergy to planned rescue medications
- Suspicion of a specific cause of low back pain (fracture, tumor, infection, inflammatory disease of the spine, HIV-infection) in the patient's history or by physical examination
- History or signs of severe dysfunction of the liver or kidney
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Social and Preventive Medicine (ISPM), University of Bern
Bern, 3012
About this study
Official title: Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial
Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work.
Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.
Read the detailed description
Design: Randomised controlled parallel-group trial comparing standard care plus spinal manipulative therapy with standard care alone. Intention-to-treat analysis.
Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern University Hospital and a primary care practice network.
- Conditions
- Low Back Pain
- Being tested
- manipulative therapy
- Keywords
- Low back pain, Spinal manipulative therapy, Randomised controlled trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulative therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain overall measured by a numeric rating scale(range 0 to 10)
Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)
Secondary outcomes (2)
Roland Morris Score
Serious adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2003
- Primary completionApr 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Society for Manual Therapy (SAMM), Insel Gruppe AG, University Hospital Bern, Wissenschaftlicher Fonds WFR
- Investigators
- Peter M. Villiger, MD, Principal investigator, Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of BernePeter Juni, MD, Study director, Department of Social and Preventive Medicine (ISPM), University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294229
- Sponsor's protocol ID
- KEK220_02
- Other IDs
- INSEL749
- Status last verified
- Sep 2011
- First submitted
- 16 Feb 2006
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00294229
- Acronym / sponsor ID
- KEK220_02
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Spinal manipulative therapy, Randomised controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss Society for Manual Therapy (SAMM), Insel Gruppe AG, University Hospital Bern, Wissenschaftlicher Fonds WFR
- Study start
- Mar 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Feb 2006 (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.
Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work.
Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.
Detailed description
Design: Randomised controlled parallel-group trial comparing standard care plus spinal manipulative therapy with standard care alone. Intention-to-treat analysis.
Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern University Hospital and a primary care practice network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 55 years
- Duration of acute low back pain less than 4 weeks
- Informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Radicular origin of back pain (with irradiation)
- Cauda equine syndrome
- Neurologic deficit
- Epidural glucocorticoid injections in the preceding three months
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 |
|---|---|---|
| manipulative therapy | Procedure or surgery | – |
Primary outcome
Back pain overall measured by a numeric rating scale(range 0 to 10)
Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)
2 secondary outcomes
Roland Morris Score
Serious adverse events
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 3 Oct 2011.
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PRP Versus NP Injections for Chronic Discogenic Low Back Pain
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Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
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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.
Peter M. Villiger, MD principal investigator
Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne
Peter Juni, MD study director
Department of Social and Preventive Medicine (ISPM), University of Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing manipulative therapy in people with Low Back Pain, run by University of Bern at 1 site in Switzerland.
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 3 inclusion and 11 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 3 Oct 2011. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Back pain overall measured by a numeric rating scale(range 0 to 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 3 Oct 2011.