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Acupuncture for Back and Neck Pain in an Emergency Room Setting (ABNP)

Primary Purpose

Back Pain, Neck Pain, Anxiety

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Real Acupuncture

Placebo Acupuncture

No intervention

About this trial

This is an interventional treatment trial for Back Pain focused on measuring back pain, neck pain, anxiety, range of motion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Acupuncture

2 Placebo acupuncture

3 No treatment

Arm Description

Real Acupuncture

No treatment performed

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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)

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

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

Full Information

NCT ID

NCT00859365

First Posted

March 10, 2009

Last Updated

January 27, 2012

Sponsor

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00859365

Brief Title

Acupuncture for Back and Neck Pain in an Emergency Room Setting

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain, Neck Pain, Anxiety, Range of Motion

Keywords

back pain, neck pain, anxiety, range of motion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Real Acupuncture

Arm Title

2 Placebo acupuncture

Arm Type

Placebo Comparator

Arm Title

3 No treatment

Arm Type

No Intervention

Arm Description

No treatment performed

Intervention Type

Procedure

Intervention Name(s)

Real Acupuncture

Intervention Description

Real acupuncture treatment in real acupuncture points

Intervention Type

Procedure

Intervention Name(s)

Placebo Acupuncture

Intervention Description

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

Intervention Name(s)

No intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Time Frame

day of treatment, after 24 hrs

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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 History of osteoporosis Declined or unable to sign informed consent Soldiers in active military service

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shmuel Bar-Haim, MD

Organizational Affiliation

Asaf Harofeh Medical Center, Zerifin, Israel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amos Ziv, M.Sc

Organizational Affiliation

Asaf Harofeh Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Asaf Harofeh Medical Center

City

Beer-Yaacob, Zerifin

ZIP/Postal Code

70300

Country

Israel

12. IPD Sharing Statement

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Acupuncture for Back and Neck Pain in an Emergency Room Setting

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