Low Back PainPhase 2NCT01357343
Integrated Chiropractic and Acupuncture Treatment for Low Back Pain
A Phase 2 study testing Chiropractic and Acupuncture in people with Low Back Pain, run by Southern California University of Health Sciences at 1 site in United States.
Trial summary
This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Chiropractic and Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years or older
- Have a current episode of low back pain
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California University of Health Sciences
Whittier, California, 90604
About this study
Official title: Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial
This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Chiropractic, Acupuncture
- Keywords
- Low back pain, Chiropractic, Acupuncture, Integrated care
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiropracticOther
Spinal manipulation and active and passive therapy.
AcupunctureOther
Acupuncture needling, moxa, Tui Na and cupping.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Acupuncture needling, moxa, Tui Na and cupping Receives: Other: Acupuncture |
| Chiropractic care | Active comparator | Chiropractic adjustments and active and passive physical modalities. Receives: Other: Chiropractic |
| Integrated Chiropractic and Acupuncture | Active comparator | Not described Receives: Other: Chiropractic; Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain numeric rating scale.
This outcome will measure changes in the participant's level of low back pain.
Measured: 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.
Measured: Change from baseline to 60 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: Change from baseline to 60 days
Self generated survey of outcomes
Frequency of symptoms, Medication use, Lost work time, Health services utilization
Measured: Change from baseline to 60 days days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anupama KizhakkeVeettil, Southern California University of Health Sciences
- Investigators
- Anupama Kizhakkeveettil, MAOM, Principal investigator, Southern California University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357343
- Sponsor's protocol ID
- KIZH003
- Status last verified
- Sep 2021
- First submitted
- 22 Mar 2011
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28259496
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Integrative Approach of Chiropractic and Traditional Chinese Medicine Care on Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01357343
- Acronym / sponsor ID
- KIZH003
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Chiropractic, Acupuncture, Integrated care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Other: AcupunctureAcupuncture needling, moxa, Tui Na and cupping |
| Chiropractic care | Active comparator | Other: ChiropracticChiropractic adjustments and active and passive physical modalities. |
| Integrated Chiropractic and Acupuncture | Active comparator | Other: Chiropractic, Other: Acupuncture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are 18 years or older
- Have a current episode of low back pain
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChiropracticSpinal manipulation and active and passive therapy. | Other | Chiropractic care, Integrated Chiropractic and Acupuncture |
| AcupunctureAcupuncture needling, moxa, Tui Na and cupping. | Other | Acupuncture, Integrated Chiropractic and Acupuncture |
Primary outcome
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.
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.
3 secondary outcomes
Quality of life
Time frame: Change from baseline to 60 days days
Patient satisfaction with treatment
Time frame: Change from baseline to 60 days
Self generated survey of outcomes
Time frame: Change from baseline to 60 days days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 28259496Kizhakkeveettil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anupama Kizhakkeveettil, MAOM principal investigator
Southern California University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chiropractic and Acupuncture in people with Low Back Pain, run by Southern California University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain numeric rating scale. (time frame: Change from baseline to 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.