Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

Sponsor

Southern California University of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01357343

Collaborator

(none)

103

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Chiropractic Other: Acupuncture	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Pain numeric rating scale. [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 [Change from baseline to 60 days]
We will be using Roland-Morris scale to measure disability due to low back pain.

Secondary Outcome Measures

Quality of life [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.
Patient satisfaction with treatment [Change from baseline to 60 days]
We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
Self generated survey of outcomes [Change from baseline to 60 days days]
Frequency of symptoms, Medication use, Lost work time, Health services utilization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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