Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

Study Overview
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Brief Summary
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This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain.

Detailed Description
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This study is being conducted at the Southern California University of Health Sciences. Eligible subjects will be randomized to one of three treatment groups: chiropractic care alone, acupuncture care alone, and chiropractic and acupuncture care combined. Subjects will be treated on pragmatic basis for 60 days and then followed up for an additional 60 days. All examinations and treatments will be provided free of charge. The expected benefits for the participants are decreased pain and improved function.

Official Title
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Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Chiropractic
* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 18 years or older Have a current episode of low back pain Exclusion Criteria: Received chiropractic treatment or other manipulative therapies within the last month Received acupuncture treatment within the last month Visceral, systemic or joint inflammatory disease with referred pain to the back or pelvis Non-mechanical low back pain A history of low back surgery Osteoporosis Spondylolisthesis Coagulation disorder or are taking anticoagulant medication Prolonged systemic corticosteroid medication Progressive unilateral lower limb muscle weakness Symptoms or signs of cauda equina syndrome (e.g., bowel or bladder dysfunction) Severe concurrent illness (e.g., cancer, heart diseases, psychiatric disorders) Known pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>Acupuncture needling, moxa, Tui Na and cupping | Other: Acupuncture<br>* Acupuncture needling, moxa, Tui Na and cupping.<br>|
| Active Comparator: Chiropractic care<br>Chiropractic adjustments and active and passive physical modalities. | Other: Chiropractic<br>* Spinal manipulation and active and passive therapy.<br>|
| Active Comparator: Integrated Chiropractic and Acupuncture<br> | Other: Chiropractic<br>* Spinal manipulation and active and passive therapy.<br>Other: Acupuncture<br>* Acupuncture needling, moxa, Tui Na and cupping.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain numeric rating scale. | This outcome will measure changes in the participant's level of low back pain. | Change from baseline to 60 days | 
| Disability due to low back pain | We will be using Roland-Morris scale to measure disability due to low back pain. | Change from baseline to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life is often reduced due to low back pain. The SF-36 outcome measure will be used to determine if the treatment has any effect on quality of life of the participants. | Change from baseline to 60 days days | 
| Patient satisfaction with treatment | We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered. | Change from baseline to 60 days | 
| Self generated survey of outcomes | Frequency of symptoms, Medication use, Lost work time, Health services utilization | Change from baseline to 60 days days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Integrated care, Low back pain, Chiropractic