Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Other: Chiropractic; Other: Acupuncture

• Registration Number: NCT01357343
• Lead Sponsor: Southern California University of Health Sciences

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Chiropractic and Acupuncture	Acupuncture	-
Chiropractic care	Chiropractic	Chiropractic adjustments and active and passive physical modalities.
Acupuncture	Acupuncture	Acupuncture needling, moxa, Tui Na and cupping
Integrated Chiropractic and Acupuncture	Chiropractic	-

Primary Outcome Measures

Name	Time	Method
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.
Pain numeric rating scale.	Change from baseline to 60 days	This outcome will measure changes in the participant's level of low back pain.

Secondary Outcome Measures

Name	Time	Method
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.
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.
Self generated survey of outcomes	Change from baseline to 60 days days	Frequency of symptoms, Medication use, Lost work time, Health services utilization

Trial Locations

Locations (1)

Southern California University of Health Sciences; 🇺🇸 Whittier, California, United States