Clinical trial NCT01357343: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Low back pain
Chiropractic
Acupuncture
Integrated care
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain numeric rating scale.
timeFrame: Change from baseline to 60 days
measure: Disability due to low back pain
timeFrame: Change from baseline to 60 days
Secondary outcomes:
measure: Quality of life
timeFrame: Change from baseline to 60 days days
measure: Patient satisfaction with treatment
timeFrame: Change from baseline to 60 days
measure: Self generated survey of outcomes
timeFrame: Change from baseline to 60 days days
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Southern California University of Health Sciences
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Anupama Kizhakkeveettil, MAOM
role: PRINCIPAL_INVESTIGATOR
References:
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.