NCT00294229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_4 low-back-pain

Timeline
Completed

Started Mar 2003

Typical duration for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

Enrollment Period

3.1 years

First QC Date

February 16, 2006

Last Update Submit

September 30, 2011

Conditions

Low Back Pain

Keywords

Low back painSpinal manipulative therapyRandomised controlled trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Roland Morris Score

  • Serious adverse events

Interventions

manipulative therapyPROCEDURE

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Peter M. Villiger, MD

    Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne

    PRINCIPAL INVESTIGATOR

  • Peter Juni, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

March 1, 2003

Primary Completion

April 1, 2006

Study Completion

October 1, 2006

Last Updated

October 3, 2011

Record last verified: 2011-09

Locations

CH(1)