Chiropractic for Back and Neck Pain in an Emergency Department Setting

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Back Pain, Neck Pain, Anxiety

Intervention / Treatment
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* Procedure: real chiropractic
* Procedure: Sham Chiropractic


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chiropractic<br>Real Chiropractic treatment | Procedure: real chiropractic<br>* real chiropractic manipulation<br>|
| Sham Comparator: Sham Chiropractic<br>stimulation utilizing 'activator' thumper | Procedure: Sham Chiropractic<br>* Placebo stimulation using 'activator' thumper<br>|
| No Intervention: No treatment<br>No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 30 minutes after medication, Immidiatly after treatment and after 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 30 minutes after medication, Immidiatly after treatment and after 24 hrs | 
| 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) |  | Immidiatly after treatment | 
| A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours |  | 24 hours after treatment | 
| A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires |  | 1 hour after the treatment and again after 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back pain, neck pain, anxiety, range of motion