NCT00307788

Brief Summary

It is our hypothesis that patient's expectations concerning treatment outcome will be influenced by their psychiatric symptoms, and that this expectancy will have a strong influence on the efficacy of acupuncture treatment to suppress experimentally induced pain. We will conduct a study, monitoring expectations but not manipulating them, in a cohort of patients with chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 low-back-pain

Timeline
Completed

Started May 2004

Longer than P75 for phase_3 low-back-pain

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

6 years

First QC Date

March 24, 2006

Last Update Submit

May 24, 2012

Conditions

Low Back Pain

Keywords

Psychiatric ComorbidityAcupunctureexpectancy

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    %change in pain

    start and end

Interventions

acupuncturePROCEDURE

acupuncture

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers between 21 and 65 years of age with discogenic low back pain, either with or without radicular pain for more than three months, assessed by the treating physician with the use of imaging. Patients with discogenic low back are chosen in order to study a more uniform pain syndrome, a concern in pain medicine research \[153\]. Patients must have pain for at least three months because 90% of back pain resolves within three months of onset, and back pain beyond this time is more likely to remain chronic \[156\].
  • Average pain intensity of ≥4 on a scale from 0 to 10, because \<4 is considered a level with acceptable pain and function
  • At least an 8th grade English-reading level; English can be a second language provided that the subjects feel they understand all the questions used in the assessment measures.
  • No long-acting opioids. Short acting opioids are acceptable, provided that subjects undergo a 7-10 day washout period. It is not possible to recruit an entirely opioid naïve population.
  • No prescription benzodiazepines.

You may not qualify if:

  • Any interventional procedure for low back or radicular pain two weeks prior to the study or during the two week study period, such as lumbar epidural steroids, nerve root blocks, or facet joint injections/ radiofrequency lesioning.
  • Having received acupuncture treatment before for any condition.
  • Back surgery in the previous 12 weeks, the intent to undergo back surgery during the study period, or any clinically unstable systemic illness that is judged to interfere with the trial.
  • Non-ambulatory status
  • History of cardiac or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  • An inability to complete questionnaires accurately.
  • Current opioid treatment through an intrathecal device
  • Cancer or other malignant disease, except carcinoma in situ of the skin or cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Management Center

Chestnut Hill, Massachusetts, 02167, United States

Location

Related Publications (1)

  • Wasan AD, Kong J, Pham LD, Kaptchuk TJ, Edwards R, Gollub RL. The impact of placebo, psychopathology, and expectations on the response to acupuncture needling in patients with chronic low back pain. J Pain. 2010 Jun;11(6):555-63. doi: 10.1016/j.jpain.2009.09.013. Epub 2010 Jan 13.

    PMID: 20075014DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ajay Wasan, M.D., MSc.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Bruce Rosen, MD, PhD

    Brigham and Womens Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

May 1, 2004

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

US(1)