Chiropractic for Back and Neck Pain in an Emergency Department Setting (CBNP)

January 27, 2012 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

Efficacy of an Integrative Approach Utilizing Chiropractic as an Add On Therapy for the Treatment Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial

This study aims to examine the efficacy of an Integrative approach utilizing Chiropractic as an add-on therapy for the treatment back and neck pain in an emergency department setting

Chiropractic is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an effective therapy for simple back and neck pain in an emergency room (ER) setting.

This study will examine weather Chiropractic can decrease pain, increase range of motion and decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain without neurological findings. Chiropractic will be performed as an add on therapy on top of analgesic therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Yaakov, Zerifin, Israel, 70300
        • Asaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain
  • Agreed to a physical examination and by an orthopedic physician and X-ray Diagnosis of simple back pain with levels of 4 < NRS at least
  • Agreed and able to fill pain, anxiety and satisfactory questioners
  • Agreed and able to sign informed consent

Exclusion Criteria:

  • Fracture, sprain or neurological deficit during physical examination
  • Pain scale of NRS < 4
  • Active pregnancy
  • Active inflammatory arthritis
  • History of CVA
  • Open wounds
  • Acute malignancy with life expectancy of less than 5 years
  • Experience with acupuncture treatments
  • History of drug addiction
  • History of osteoporosis
  • Declined or unable to sign informed consent
  • Soldiers in active military service
  • Received a chiropractic treatment in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chiropractic
Real Chiropractic treatment
Procedure: real chiropractic
real chiropractic manipulation
Sham Comparator: Sham Chiropractic
stimulation utilizing 'activator' thumper
Procedure: Sham Chiropractic
Placebo stimulation using 'activator' thumper
No Intervention: No treatment
No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A comparable difference in pain levels between a combined medication and chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
Time Frame: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
30 minutes after medication, Immidiatly after treatment and after 24 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
A comparable difference in range of motion between a combined medication and chiropractic treatment to medication treatment alone as measured by Spine Scan Device and physical exam using goniometer
Time Frame: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
30 minutes after medication, Immidiatly after treatment and after 24 hrs
A comparable difference in patient self reported anxiety assessed by Hebrew version of the anxiety and somatization sections of the Symptom Check List-90 questioner (SCL-90)
Time Frame: Immidiatly after treatment
Immidiatly after treatment
A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours
Time Frame: 24 hours after treatment
24 hours after treatment
A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
Time Frame: 1 hour after the treatment and again after 1 week
1 hour after the treatment and again after 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Shmuel Bar-Haim, MD, Asaf Harofeh Medical Center, Zerifin, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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