Acupuncture for Back and Neck Pain in an Emergency Room Setting

Anxiety Clinical Trial

— ABNP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859365
• Other study ID #: 127/08
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 10, 2009
• Last updated: January 27, 2012
• Start date: January 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Neck Pain
• Range of Motion

Intervention

Procedure:
• Real Acupuncture
Real acupuncture treatment in real acupuncture points
• 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
Patients lay down for a period of 35 minutes without any treatment o intervention

Locations

Country	Name	City	State
Israel	Asaf Harofeh Medical Center	Beer-Yaacob, Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes