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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

August 11, 2009
January 27, 2012
May 2009
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00964717 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chiropractic for Back and Neck Pain in an Emergency Department Setting
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Back Pain
  • Neck Pain
  • Anxiety
  • Procedure: real chiropractic
    real chiropractic manipulation
  • Procedure: Sham Chiropractic
    Placebo stimulation using 'activator' thumper
  • Active Comparator: Chiropractic
    Real Chiropractic treatment
    Intervention: Procedure: real chiropractic
  • Sham Comparator: Sham Chiropractic
    stimulation utilizing 'activator' thumper
    Intervention: Procedure: Sham Chiropractic
  • No Intervention: No treatment
    No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00964717
126/08
Yes
Assaf Harofeh MC, Assaf-Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Principal Investigator: Shmuel Bar-Haim, MD Asaf Harofeh Medical Center, Zerifin, Israel
Assaf-Harofeh Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP