Clinical trial NCT00964717: Chiropractic for Back and Neck Pain in an Emergency Department Setting
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Back Pain
Neck Pain
Anxiety
Keywords: back pain
neck pain
anxiety
range of motion
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-08-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
Secondary outcomes:
measure: 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
timeFrame: 30 minutes after medication, Immidiatly after treatment and after 24 hrs
measure: 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)
timeFrame: Immidiatly after treatment
measure: A comparable difference in the amount of analgesic pain medication consumed by the patients during the day of treatment and after 24 hours
timeFrame: 24 hours after treatment
measure: A comparable difference in safety and patient satisfactory as measured by overall satisfactory and safety questionnaires
timeFrame: 1 hour after the treatment and again after 1 week
Other outcomes:
Locations:
city: Beer Yaakov, Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
affiliation: Asaf Harofeh Medical Center, Zerifin, Israel
name: Shmuel Bar-Haim, MD
role: PRINCIPAL_INVESTIGATOR
References: