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Chiropractic for Back and Neck Pain in an Emergency Department Setting (CBNP)

Primary Purpose

Back Pain, Neck Pain, Anxiety

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
real chiropractic
Sham Chiropractic
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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
  • 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
  • Received a chiropractic treatment in the past

Sites / Locations

  • Asaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Chiropractic

Sham Chiropractic

No treatment

Arm Description

Real Chiropractic treatment

stimulation utilizing 'activator' thumper

No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention

Outcomes

Primary Outcome Measures

A comparable difference in pain levels between a combined medication and chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)

Secondary Outcome Measures

A comparable difference in range of motion between a combined medication and chiropractic treatment to medication treatment alone as measured by Spine Scan Device and physical exam using goniometer
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)
A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours
A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires

Full Information

First Posted
August 11, 2009
Last Updated
January 27, 2012
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00964717
Brief Title
Chiropractic for Back and Neck Pain in an Emergency Department Setting
Acronym
CBNP
Official Title
Efficacy of an Integrative Approach Utilizing Chiropractic as an Add On Therapy for the Treatment 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
May 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 Chiropractic as an add-on therapy for the treatment back and neck pain in an emergency department setting Chiropractic is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an effective therapy for simple back and neck pain in an emergency room (ER) setting. This study will examine weather Chiropractic 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. Chiropractic 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
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
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chiropractic
Arm Type
Active Comparator
Arm Description
Real Chiropractic treatment
Arm Title
Sham Chiropractic
Arm Type
Sham Comparator
Arm Description
stimulation utilizing 'activator' thumper
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention
Intervention Type
Procedure
Intervention Name(s)
real chiropractic
Intervention Description
real chiropractic manipulation
Intervention Type
Procedure
Intervention Name(s)
Sham Chiropractic
Intervention Description
Placebo stimulation using 'activator' thumper
Primary Outcome Measure Information:
Title
A comparable difference in pain levels between a combined medication and chiropractic treatment to medication treatment alone as measured by the Numeric Rating Scale (NRS)
Time Frame
30 minutes after medication, Immidiatly after treatment and after 24 hrs
Secondary Outcome Measure Information:
Title
A comparable difference in range of motion between a combined medication and chiropractic treatment to medication treatment alone as measured by Spine Scan Device and physical exam using goniometer
Time Frame
30 minutes after medication, Immidiatly after treatment and after 24 hrs
Title
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
Immidiatly after treatment
Title
A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours
Time Frame
24 hours after treatment
Title
A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
Time Frame
1 hour after the treatment and again after 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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 Received a chiropractic treatment in the past
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
Facility Information:
Facility Name
Asaf Harofeh Medical Center
City
Beer Yaakov, Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

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Chiropractic for Back and Neck Pain in an Emergency Department Setting

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