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Spinal Manipulative Therapy for Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00294229
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : October 3, 2011
Information provided by:

Study Description
Brief 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.

Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: manipulative therapy Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial
Study Start Date : March 2003
Primary Completion Date : April 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Back pain overall measured by a numeric rating scale(range 0 to 10)
  2. Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)

Secondary Outcome Measures :
  1. Roland Morris Score
  2. Serious adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Age between 20 and 55 years
  2. Duration of acute low back pain less than 4 weeks
  3. Informed consent

Exclusion criteria:

  1. Pregnancy
  2. Radicular origin of back pain (with irradiation)
  3. Cauda equine syndrome
  4. Neurologic deficit
  5. Epidural glucocorticoid injections in the preceding three months
  6. Previous low back surgery
  7. Severe osteoporosis
  8. Blood-coagulation disorder
  9. Allergy to planned rescue medications
  10. 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
  11. History or signs of severe dysfunction of the liver or kidney
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294229

Department of Social and Preventive Medicine (ISPM), University of Bern
Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Swiss Society for Manual Therapy (SAMM)
University Hospital Inselspital, Berne
Wissenschaftlicher Fonds WFR
Principal Investigator: Peter M. Villiger, MD Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne
Study Director: Peter Juni, MD Department of Social and Preventive Medicine (ISPM), University of Berne
More Information

Responsible Party: Department of Social and Preventive Medicine (ISPM), University of Bern
ClinicalTrials.gov Identifier: NCT00294229     History of Changes
Other Study ID Numbers: KEK220_02
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Keywords provided by University of Bern:
Low back pain
Spinal manipulative therapy
Randomised controlled trial

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms