NCT00065585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for phase_3 low-back-pain

Timeline
Completed

Started Apr 2004

Typical duration for phase_3 low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2003

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

July 28, 2003

Last Update Submit

October 3, 2019

Conditions

Low Back Pain

Keywords

low back painacupuncture

Study Arms (4)

Usual care

NO INTERVENTION

non needle control

PLACEBO COMPARATOR
Procedure: Accupuncture

Acupuncture - Standardized Points

SHAM COMPARATOR
Procedure: Accupuncture

Accupunture - Experimental Points

EXPERIMENTAL
Procedure: Accupuncture

Interventions

AccupuncturePROCEDURE
Accupunture - Experimental PointsAcupuncture - Standardized Pointsnon needle control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente Northern California, Kaiser Foundation Research Institute

Oakland, California, United States

Location

Group Health Cooperative, Center for Health Studies

Seattle, Washington, United States

Location

Related Publications (3)

  • 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.

    PMID: 18307808BACKGROUND

  • 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.

    PMID: 19433697RESULT

  • 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.

    PMID: 19860906DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Cherkin, PhD

    Group Health Cooperative Center for Health Studies

    STUDY DIRECTOR

  • Karen J Sherman, PhD

    Group Health Cooperative Center for Health Studies

    PRINCIPAL INVESTIGATOR

  • Andy Avins, MD

    Kaiser Foundation Research Institute, Kaiser Permanente Northern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2003

First Posted

July 31, 2003

Study Start

April 1, 2004

Primary Completion

September 1, 2006

Study Completion

June 1, 2007

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

US(2)