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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sham Chiropractic
stimulation utilizing 'activator' thumper
Intervention: Sham Chiropractic (Procedure)
No treatment
No add on therapy - patients lay down for a period of 15 minutes without any treatment or intervention
Chiropractic
Real Chiropractic treatment
Intervention: real chiropractic (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Assaf Harofeh MC
Head of Emergency Department
Assaf-Harofeh Medical Center