Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chiropractic
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Chiropractic, Acupuncture, Integrated care
Eligibility Criteria
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
Sites / Locations
- Southern California University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Acupuncture
Chiropractic care
Integrated Chiropractic and Acupuncture
Arm Description
Acupuncture needling, moxa, Tui Na and cupping
Chiropractic adjustments and active and passive physical modalities.
Outcomes
Primary Outcome Measures
Pain numeric rating scale.
This outcome will measure changes in the participant's level of low back pain.
Disability due to low back pain
We will be using Roland-Morris scale to measure disability due to low back pain.
Secondary Outcome Measures
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.
Patient satisfaction with treatment
We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
Self generated survey of outcomes
Frequency of symptoms, Medication use, Lost work time, Health services utilization
Full Information
NCT ID
NCT01357343
First Posted
March 22, 2011
Last Updated
September 21, 2021
Sponsor
Southern California University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01357343
Brief Title
Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
Official Title
Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Chiropractic, Acupuncture, Integrated care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture needling, moxa, Tui Na and cupping
Arm Title
Chiropractic care
Arm Type
Active Comparator
Arm Description
Chiropractic adjustments and active and passive physical modalities.
Arm Title
Integrated Chiropractic and Acupuncture
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Chiropractic
Intervention Description
Spinal manipulation and active and passive therapy.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture needling, moxa, Tui Na and cupping.
Primary Outcome Measure Information:
Title
Pain numeric rating scale.
Description
This outcome will measure changes in the participant's level of low back pain.
Time Frame
Change from baseline to 60 days
Title
Disability due to low back pain
Description
We will be using Roland-Morris scale to measure disability due to low back pain.
Time Frame
Change from baseline to 60 days
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
Change from baseline to 60 days days
Title
Patient satisfaction with treatment
Description
We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
Time Frame
Change from baseline to 60 days
Title
Self generated survey of outcomes
Description
Frequency of symptoms, Medication use, Lost work time, Health services utilization
Time Frame
Change from baseline to 60 days days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anupama Kizhakkeveettil, MAOM
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28259496
Citation
Kizhakkeveettil A, Rose KA, Kadar GE, Hurwitz EL. Integrative Acupuncture and Spinal Manipulative Therapy Versus Either Alone for Low Back Pain: A Randomized Controlled Trial Feasibility Study. J Manipulative Physiol Ther. 2017 Mar-Apr;40(3):201-213. doi: 10.1016/j.jmpt.2017.01.002. Epub 2017 Mar 1.
Results Reference
derived
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Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
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