Acupuncture for Back and Neck Pain in an Emergency Room Setting

Phase 1

Completed

• Conditions: Back Pain; Neck Pain; Anxiety; Range of Motion
• Interventions: Procedure: Real Acupuncture; Procedure: Placebo Acupuncture; Procedure: No intervention

• Registration Number: NCT00859365
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Real Acupuncture	Real Acupuncture
2 Placebo acupuncture	Placebo Acupuncture	-
3 No treatment	No intervention	No treatment performed

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Asaf Harofeh Medical Center; 🇮🇱 Beer-Yaacob, Zerifin, Israel