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Completed

NCT Number: NCT00294229

Spinal Manipulative Therapy for Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bern, 3012, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

manipulative therapy

Procedure

Primary outcomes

  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 outcomes

  1. Roland Morris Score

  2. Serious adverse events

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern
  • Swiss Society for Manual Therapy (SAMM)
  • Wissenschaftlicher Fonds WFR

Registry information

Official study title

Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Feb 20, 2006
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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