Spinal Manipulative Therapy for Low Back Pain - Full Text View

Spinal Manipulative Therapy for Low Back Pain

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Bern Swiss Society for Manual Therapy (SAMM) University Hospital Inselspital, Berne Wissenschaftlicher Fonds WFR
Information provided by:	University of Bern
ClinicalTrials.gov Identifier:	NCT00294229

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 IV

MedlinePlus related topics:

Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

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

Estimated Enrollment:	102
Study Start Date:	April 2003

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:

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

Exclusion criteria:

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
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

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

Responsible Party:	University of Bern ( Department of Social and Preventive Medicine (ISPM) )
Study ID Numbers:	KEK220_02, INSEL749
First Received:	February 16, 2006
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00294229
Health Authority:	Switzerland: Ethikkommision

Keywords provided by University of Bern:

Low back pain

Spinal manipulative therapy

Randomised controlled trial

Study placed in the following topic categories:

Signs and Symptoms

Neurologic Manifestations

Low Back Pain

Pain

Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2008