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Clinical Trials/NCT00859365
NCT00859365
Completed
Phase 1

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

Assaf-Harofeh Medical Center1 site in 1 country65 target enrollmentJanuary 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Back Pain
Sponsor
Assaf-Harofeh Medical Center
Enrollment
65
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
September 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Assaf Harofeh MC

Head of Emergency Department

Assaf-Harofeh Medical Center

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

Outcomes

Primary Outcomes

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)

Time Frame: At day of treatment, after 24 hrs

Secondary Outcomes

  • 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)

Study Sites (1)

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