NCT00065975

Brief Summary

This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

August 1, 2003

Last Update Submit

August 16, 2006

Conditions

Chronic Low Back Pain

Keywords

chronic low back painacupuncturechiropracticmassage therapyCAM therapies

Interventions

massage therapyPROCEDURE
chiropracticPROCEDURE
acupuncturePROCEDURE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Low back pain duration of at least 3 months; * Low back pain occurring in the past week; * No numbness or tingling in the lower extremities; * No pain that radiates to below the knee; * No use of massage, chiropractic or acupuncture for any reason in the past year; * Able to attend scheduled appointments; * Able to hear, read, and understand English; * No low back pain surgery in the past 3 years; * No unexplained weight loss; * No previous vertebral or spinal fractures; * No previous non-traumatic bone fractures; * No other spinal pathology, including scoliosis, spinal stenosis, osteoporosis, or ankylosing spondylitis; * No cancer (except simple skin cancers) in the past 5 years; * No pacemakers; * No bleeding problems or anticoagulant use; * No major organ transplants; * No oral corticosteroid use for more than 4 consecutive weeks during the past year; * Cannot be pregnant; * Must be able to get down to and up from the floor by yourself; * Able to walk 2 flat city blocks unassisted; * Willing to participate in periodic telephone interviews.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Harvard medical school

Boston, Massachusetts, 00000, United States

Location

Harvard Vanguard Medical Associates

Boston, Massachusetts, 00000, United States

Location

MeSH Terms

Interventions

MassageManipulation, ChiropracticAcupuncture Therapy

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • David Eisenberg, MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

April 1, 2002

Study Completion

December 1, 2002

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(2)