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NCT Number: NCT00859365

Acupuncture for Back and Neck Pain in an Emergency Room Setting

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.

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Key information

Conditions

Back Pain Anxiety Anxiety Disorders Mental Disorders Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Range of Motion Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asaf Harofeh Medical Center

Beer-Yaacob, Zerifin, Israel, 70300

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real Acupuncture

Procedure

Real acupuncture treatment in real acupuncture points

Placebo acupuncture

Procedure

empty plastic acupuncture guide-tube located on the patients back in a non visable area and connected to a visible electric stimulator

No intervention

Procedure

Patients lay down for a period of 35 minutes without any treatment o intervention

Primary outcomes

  1. 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

  1. 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

    Time frame: day of treatment, after 24 hrs

  2. 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)

    Time frame: day of treatment

  3. 4.2.3 A comparable difference in the amount of analgesic pain medication consumed by the patients during the week following the treatment

    Time frame: day of treatment and after 24 hours

  4. 4.2.4 A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires

    Time frame: day of treatment, after 1 weekl

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study 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

Acronym: ABNP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 11, 2009
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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