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Spinal Manipulative Therapy for Low Back Pain

This study has been completed.
Sponsor:
Collaborators:
Swiss Society for Manual Therapy (SAMM)
University Hospital Inselspital, Berne
Wissenschaftlicher Fonds WFR
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00294229
First received: February 16, 2006
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Low Back Pain
 Procedure: manipulative therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

Resource links provided by NLM:

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

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Roland Morris Score
  • Serious adverse events

Enrollment: 104
Study Start Date: March 2003
Study Completion Date: October 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294229

Locations
Switzerland
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
Investigators
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

No publications provided

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, INSEL749
Study First Received: February 16, 2006
Last Updated: September 30, 2011
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on June 13, 2013