Spinal Manipulative Therapy for Low Back Pain

Condition(s) targeted: Low Back Pain

Intervention: manipulative therapy (Procedure)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Bern

Official(s) and/or principal investigator(s):
Peter M. Villiger, MD, Principal Investigator, Affiliation: Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne
Peter Juni, MD, Study Director, Affiliation: Department of Social and Preventive Medicine (ISPM), University of Berne

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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)

Secondary outcome:

Roland Morris Score

Serious adverse events

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 the University Hospital Berne and a primary care practice network.

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.

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

Department of Social and Preventive Medicine (ISPM), University of Bern, Bern 3012, Switzerland

Starting date: April 2003
Last updated: October 19, 2006