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Acupuncture for Back and Neck Pain in an Emergency Room Setting (ABNP)

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ClinicalTrials.gov Identifier: NCT00859365
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:

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

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

This study will examine weather Acupuncture 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. Acupuncture will be performed as an add on therapy on top of analgesic therapy.


Condition or disease Intervention/treatment Phase
Back Pain Neck Pain Anxiety Range of Motion Procedure: Real Acupuncture Procedure: Placebo Acupuncture Procedure: No intervention Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of an Integrative Approach Utilizing Acupuncture as an add-on Therapy for the Treatment of Back and Neck Pain in an Emergency Department Setting - A Comparative Randomized Controlled Trial
Study Start Date : January 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Real Acupuncture
Procedure: Real Acupuncture
Real acupuncture treatment in real acupuncture points

Placebo Comparator: 2 Placebo acupuncture Procedure: Placebo Acupuncture
empty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator

No Intervention: 3 No treatment
No treatment performed
Procedure: No intervention
Patients lay down for a period of 35 minutes without any treatment o intervention




Primary Outcome Measures :
  1. A comparable difference in pain levels between a combined medication and acupuncture treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS) [ Time Frame: At day of treatment, after 24 hrs ]

Secondary Outcome Measures :
  1. 4.2.1 A comparable difference in range of motion between a combined medication and acupuncture treatment to medication treatment alone as measured by Spine Scan Device and physical exam using gonoimeter [ Time Frame: day of treatment, after 24 hrs ]
  2. 4.2.2 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: day of treatment ]
  3. 4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment [ Time Frame: day of treatment and after 24 hours ]
  4. 4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires [ Time Frame: day of treatment, after 1 weekl ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
  • Referred or radiating pain
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859365


Locations
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Israel
Asaf Harofeh Medical Center
Beer-Yaacob, Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Shmuel Bar-Haim, MD Asaf Harofeh Medical Center, Zerifin, Israel
Study Director: Amos Ziv, M.Sc Asaf Harofeh Medical Center

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Responsible Party: Assaf Harofeh MC, Head of Emergency Department, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00859365     History of Changes
Other Study ID Numbers: 127/08
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
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Back Pain
Emergencies
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes