Acupuncture for Back and Neck Pain in an Emergency Room Setting

NCT ID: NCT00859365

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Back Pain Neck Pain Anxiety Range of Motion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acupuncture

Real Acupuncture

Group Type EXPERIMENTAL

Real Acupuncture

Intervention Type PROCEDURE

Real acupuncture treatment in real acupuncture points

2 Placebo acupuncture

Group Type PLACEBO_COMPARATOR

Placebo Acupuncture

Intervention Type PROCEDURE

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

3 No treatment

No treatment performed

Group Type NO_INTERVENTION

No intervention

Intervention Type PROCEDURE

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

Interventions

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Real Acupuncture

Real acupuncture treatment in real acupuncture points

Intervention Type PROCEDURE

Placebo Acupuncture

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

Intervention Type PROCEDURE

No intervention

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Head of Emergency Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shmuel Bar-Haim, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf Harofeh Medical Center, Zerifin, Israel

Amos Ziv, M.Sc

Role: STUDY_DIRECTOR

Asaf Harofeh Medical Center

Locations

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Asaf Harofeh Medical Center

Beer-Yaacob, Zerifin, Israel, Israel

Site Status

Countries

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Israel

Other Identifiers

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127/08

Identifier Type: -

Identifier Source: org_study_id

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