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Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chiropractic
Acupuncture
Sponsored by
Southern California University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Chiropractic, Acupuncture, Integrated care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Southern California University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Acupuncture

Chiropractic care

Integrated Chiropractic and Acupuncture

Arm Description

Acupuncture needling, moxa, Tui Na and cupping

Chiropractic adjustments and active and passive physical modalities.

Outcomes

Primary Outcome Measures

Pain numeric rating scale.
This outcome will measure changes in the participant's level of low back pain.
Disability due to low back pain
We will be using Roland-Morris scale to measure disability due to low back pain.

Secondary Outcome Measures

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.
Patient satisfaction with treatment
We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
Self generated survey of outcomes
Frequency of symptoms, Medication use, Lost work time, Health services utilization

Full Information

First Posted
March 22, 2011
Last Updated
September 21, 2021
Sponsor
Southern California University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01357343
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Chiropractic, Acupuncture, Integrated care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture needling, moxa, Tui Na and cupping
Arm Title
Chiropractic care
Arm Type
Active Comparator
Arm Description
Chiropractic adjustments and active and passive physical modalities.
Arm Title
Integrated Chiropractic and Acupuncture
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Chiropractic
Intervention Description
Spinal manipulation and active and passive therapy.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture needling, moxa, Tui Na and cupping.
Primary Outcome Measure Information:
Title
Pain numeric rating scale.
Description
This outcome will measure changes in the participant's level of low back pain.
Time Frame
Change from baseline to 60 days
Title
Disability due to low back pain
Description
We will be using Roland-Morris scale to measure disability due to low back pain.
Time Frame
Change from baseline to 60 days
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
Change from baseline to 60 days days
Title
Patient satisfaction with treatment
Description
We will be using Cherkin-satisfaction scale to measure patient's satisfaction with the treatment offered.
Time Frame
Change from baseline to 60 days
Title
Self generated survey of outcomes
Description
Frequency of symptoms, Medication use, Lost work time, Health services utilization
Time Frame
Change from baseline to 60 days days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anupama Kizhakkeveettil, MAOM
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28259496
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.
Results Reference
derived

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Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

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