Acupuncture for Back and Neck Pain in an Emergency Room Setting

Study Overview
=================
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.

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

Conditions
-----------------
Back Pain, Neck Pain, Anxiety, Range of Motion

Intervention / Treatment
-----------------
* Procedure: Real Acupuncture
* Procedure: Placebo Acupuncture
* Procedure: No intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Real Acupuncture | Procedure: Real Acupuncture<br>* Real acupuncture treatment in real acupuncture points<br>|
| Placebo Comparator: 2 Placebo acupuncture<br> | Procedure: Placebo Acupuncture<br>* empty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator<br>|
| No Intervention: 3 No treatment<br>No treatment performed | Procedure: No intervention<br>* Patients lay down for a period of 35 minutes without any treatment o intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
back pain, neck pain, anxiety, range of motion