Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
This study is currently recruiting participants.
Verified April 2013 by Southern California University of Health Sciences
Sponsor:
Southern California University of Health Sciences
Information provided by (Responsible Party):
Anupama KizhakkeVeettil, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01357343
First received: March 22, 2011
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Other: Chiropractic Other: Acupuncture |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Southern California University of Health Sciences:
Primary Outcome Measures:
- Pain numeric rating scale. [ Time Frame: Change from baseline to 120 days ] [ Designated as safety issue: No ]This outcome will measure changes in the participant's level of low back pain.
- Disability due to low back pain [ Time Frame: Change from baseline to 120 days ] [ Designated as safety issue: No ]We will be using Roland-Morris scale to measure disability due to low back pain.
Secondary Outcome Measures:
- Quality of life [ Time Frame: Change from baseline to 120 days days ] [ Designated as safety issue: No ]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 [ Time Frame: Change from baseline to 120 days ] [ Designated as safety issue: No ]We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
- Self generated survey of outcomes [ Time Frame: Change from baseline to 120 days days ] [ Designated as safety issue: No ]Frequency of symptoms, Medication use, Lost work time, Health services utilization
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Acupuncture
Acupuncture needling, moxa, Tui Na and cupping
|
Other: Acupuncture
Acupuncture needling, moxa, Tui Na and cupping.
|
|
Active Comparator: Chiropractic care
Chiropractic adjustments and active and passive physical modalities.
|
Other: Chiropractic
Spinal manipulation and active and passive therapy.
|
| Active Comparator: Integrated Chiropractic and Acupuncture |
Other: Chiropractic
Spinal manipulation and active and passive therapy.
Other: Acupuncture
Acupuncture needling, moxa, Tui Na and cupping.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357343
Contacts
| Contact: Anupama Kizhakkeveettil, MAOM | 562-947-8755 ext 493 | anupamakizhakkeveett@scuhs.edu |
Locations
| United States, California | |
| Southern California University of Health Sciences | Recruiting |
| Whittier, California, United States, 90604 | |
| Principal Investigator: Anupama Kizhakkeveettil, MAOM | |
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
| Principal Investigator: | Anupama Kizhakkeveettil, MAOM | Southern California University of Health Sciences |
More Information
No publications provided
| Responsible Party: | Anupama KizhakkeVeettil, Assistant Professor, Southern California University of Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01357343 History of Changes |
| Other Study ID Numbers: | KIZH003 |
| Study First Received: | March 22, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southern California University of Health Sciences:
|
Low back pain Chiropractic Acupuncture Integrated care |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013