NCT00859365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

2.7 years

First QC Date

March 10, 2009

Last Update Submit

January 27, 2012

Conditions

Back PainNeck PainAnxietyRange of Motion

Keywords

back painneck painanxietyrange of motion

Outcome Measures

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)

    At day of treatment, after 24 hrs

Secondary Outcomes (4)

  • 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 Arms (3)

Acupuncture

EXPERIMENTAL

Real Acupuncture

Procedure: Real Acupuncture

2 Placebo acupuncture

PLACEBO COMPARATOR
Procedure: Placebo Acupuncture

3 No treatment

NO INTERVENTION

No treatment performed

Procedure: No intervention

Interventions

Real AcupuncturePROCEDURE

Real acupuncture treatment in real acupuncture points

Acupuncture
Placebo AcupuncturePROCEDURE

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

2 Placebo acupuncture
No interventionPROCEDURE

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

3 No treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh Medical Center

Beer-Yaacob, Zerifin, Israel, 70300, Israel

Location

MeSH Terms

Conditions

Back PainNeck PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Shmuel Bar-Haim, MD

    Asaf Harofeh Medical Center, Zerifin, Israel

    PRINCIPAL INVESTIGATOR

  • Amos Ziv, M.Sc

    Asaf Harofeh Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Emergency Department

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

IL(1)