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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00964717
First received: August 11, 2009
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Back Pain
Neck Pain
Anxiety
 Procedure: real chiropractic
Procedure: Sham Chiropractic
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964717

Locations
Israel
Asaf Harofeh Medical Center
Beer Yaakov, Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Shmuel Bar-Haim, MD Asaf Harofeh Medical Center, Zerifin, Israel
  More Information

No publications provided

Responsible Party: Assaf Harofeh MC, Head of Emergency Department, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00964717     History of Changes
Other Study ID Numbers: 126/08
Study First Received: August 11, 2009
Last Updated: January 27, 2012
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Assaf-Harofeh Medical Center:
back pain
neck pain
anxiety
range of motion

Additional relevant MeSH terms:
Anxiety Disorders
Back Pain
Neck Pain
Emergencies
Mental Disorders
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013