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

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Anxiety; Neck Pain; Range of Motion
• Intervention / Treatment: Procedure: Real Acupuncture; Procedure: Placebo Acupuncture; Procedure: No intervention

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Beer-Yaacob, Zerifin, Israel, 70300
    • Asaf Harofeh Medical Center

Participation Criteria

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	At day of treatment, after 24 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
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	day of treatment, after 24 hrs
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)	day of treatment
4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment	day of treatment and after 24 hours
4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires	day of treatment, after 1 weekl

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Shmuel Bar-Haim, MD, Asaf Harofeh Medical Center, Zerifin, Israel; Study Director: Amos Ziv, M.Sc, Asaf Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (Estimate): March 11, 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: back pain; neck pain; anxiety; range of motion
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Back Pain; Neck Pain
• Other Study ID Numbers: 127/08