Clinical trial NCT00859365: Acupuncture for Back and Neck Pain in an Emergency Room Setting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Back Pain
Neck Pain
Anxiety
Range of Motion
Keywords: back pain
neck pain
anxiety
range of motion
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: At day of treatment, after 24 hrs
Secondary outcomes:
measure: 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
timeFrame: day of treatment, after 24 hrs
measure: 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)
timeFrame: day of treatment
measure: 4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment
timeFrame: day of treatment and after 24 hours
measure: 4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
timeFrame: day of treatment, after 1 weekl
Other outcomes:
Locations:
city: Beer-Yaacob, Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
affiliation: Asaf Harofeh Medical Center, Zerifin, Israel
name: Shmuel Bar-Haim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asaf Harofeh Medical Center
name: Amos Ziv, M.Sc
role: STUDY_DIRECTOR
References: