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Efficacy of Acupuncture for Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Accupuncture
Sponsored by
Kaiser Permanente
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, acupuncture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Diagnosis of low back pain including lumbago, unspecified backache, sprains and strains of sacroiliac, lumbar, sacral, or unspecified regions of the spine Back pain must be of at least 3 months duration and rated at least 3 on a symptom bothersomeness scale Exclusion criteria: non-mechanical causes or potential causes of low back pain (i.e. sciatica, underlying systemic or visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer or unexplained weight loss, recent vertebral fracture) previous treatment with acupuncture inappropriate candidate for acupuncture (i.e. severe clotting disorders or on anticoagulant medication, heart pacemakers) characteristics complicating the interpretation of the findings (severe or progressive neurologic deficits, back surgery within the prior three years, planning to seek other treatment for back pain) characteristics related to ability to complete the study protocol (unable to speak English, plans to move out of town)

Sites / Locations

  • Kaiser Permanente Northern California, Kaiser Foundation Research Institute
  • Group Health Cooperative, Center for Health Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Placebo Comparator

Sham Comparator

Experimental

Arm Label

Usual care

non needle control

Acupuncture - Standardized Points

Accupunture - Experimental Points

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 28, 2003
Last Updated
October 3, 2019
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00065585
Brief Title
Efficacy of Acupuncture for Chronic Low Back Pain
Official Title
Efficacy of Acupuncture for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.
Detailed Description
This is a 4-arm multi-site randomized controlled trial to clarify the extent to which various types of acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. Reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. Recent higher quality trials suggest acupuncture is a promising treatment for back pain. This study directly addresses methodological shortcomings that have plagued previous studies. A total of 640 subjects (160 per arm) with low back pain lasting at least 3 months will be recruited from group model HMOs in Seattle, WA and Oakland, CA. They will be randomized to one of three different methods of stimulation of acupuncture or to continue usual medical care. Ten treatments will be provided over 7 weeks. The primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment. Analysis of covariance within an intention-to-treat context will be used to analyze the data. Because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. Results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.

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, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
640 (false)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
non needle control
Arm Type
Placebo Comparator
Arm Title
Acupuncture - Standardized Points
Arm Type
Sham Comparator
Arm Title
Accupunture - Experimental Points
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Accupuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of low back pain including lumbago, unspecified backache, sprains and strains of sacroiliac, lumbar, sacral, or unspecified regions of the spine Back pain must be of at least 3 months duration and rated at least 3 on a symptom bothersomeness scale Exclusion criteria: non-mechanical causes or potential causes of low back pain (i.e. sciatica, underlying systemic or visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer or unexplained weight loss, recent vertebral fracture) previous treatment with acupuncture inappropriate candidate for acupuncture (i.e. severe clotting disorders or on anticoagulant medication, heart pacemakers) characteristics complicating the interpretation of the findings (severe or progressive neurologic deficits, back surgery within the prior three years, planning to seek other treatment for back pain) characteristics related to ability to complete the study protocol (unable to speak English, plans to move out of town)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cherkin, PhD
Organizational Affiliation
Group Health Cooperative Center for Health Studies
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karen J Sherman, PhD
Organizational Affiliation
Group Health Cooperative Center for Health Studies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andy Avins, MD
Organizational Affiliation
Kaiser Foundation Research Institute, Kaiser Permanente Northern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California, Kaiser Foundation Research Institute
City
Oakland
State/Province
California
Country
United States
Facility Name
Group Health Cooperative, Center for Health Studies
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18307808
Citation
Cherkin DC, Sherman KJ, Hogeboom CJ, Erro JH, Barlow WE, Deyo RA, Avins AL. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial. Trials. 2008 Feb 28;9:10. doi: 10.1186/1745-6215-9-10.
Results Reference
background
PubMed Identifier
19433697
Citation
Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
Results Reference
result
PubMed Identifier
19860906
Citation
Sherman KJ, Hawkes RJ, Ichikawa L, Cherkin DC, Deyo RA, Avins AL, Khalsa PS. Comparing recruitment strategies in a study of acupuncture for chronic back pain. BMC Med Res Methodol. 2009 Oct 27;9:69. doi: 10.1186/1471-2288-9-69.
Results Reference
derived

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Efficacy of Acupuncture for Chronic Low Back Pain

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