- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357343
Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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California
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Whittier, California, United States, 90604
- Southern California University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Acupuncture
Acupuncture needling, moxa, Tui Na and cupping
|
Acupuncture needling, moxa, Tui Na and cupping.
|
Active Comparator: Chiropractic care
Chiropractic adjustments and active and passive physical modalities.
|
Spinal manipulation and active and passive therapy.
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Active Comparator: Integrated Chiropractic and Acupuncture
|
Acupuncture needling, moxa, Tui Na and cupping.
Spinal manipulation and active and passive therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain numeric rating scale.
Time Frame: Change from baseline to 60 days
|
This outcome will measure changes in the participant's level of low back pain.
|
Change from baseline to 60 days
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Disability due to low back pain
Time Frame: Change from baseline to 60 days
|
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
Time Frame: Change from baseline to 60 days days
|
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
Time Frame: Change from baseline to 60 days
|
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
Time Frame: Change from baseline to 60 days days
|
Frequency of symptoms, Medication use, Lost work time, Health services utilization
|
Change from baseline to 60 days days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anupama Kizhakkeveettil, MAOM, Southern California University of Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIZH003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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