NCT00118859

Brief Summary

This pilot study will determine the feasibility of enrolling participants from different populations for a larger study of low back pain (LBP) treatment. In addition, this study will assess the effectiveness of data collection instruments and procedures as well as utilize feedback from participants to refine a future study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable low-back-pain

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

July 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

December 11, 2009

Status Verified

December 1, 2009

First QC Date

July 7, 2005

Last Update Submit

December 10, 2009

Conditions

Low Back Pain

Keywords

Back PainIntegrative CareAcupunctureChiropracticExerciseMassage TherapyMind-Body TherapyNutritional CounselingComplementary TherapiesComplementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

  • LBP symptoms

Secondary Outcomes (2)

  • Feasibility of enrolling LBP patients from different populations

  • effectiveness of data collection instruments and procedures

Interventions

Integrative care for low back painBEHAVIORAL
Conventional treatment for low back painBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Low back pain beginning 3 to 6 weeks prior to study entry
  • Patient of Partners Occupational Health Center or Harvard Vanguard Medical Associates (HVMA)
  • Able to speak and understand English
  • Willing and able to comply with all study requirements

You may not qualify if:

  • History of back surgery within 3 years prior to study entry
  • History of vertebral fracture or dislocation
  • Progressive or severe neurological symptoms such as loss of bowel or bladder control, numbness in groin or rectal area, or extreme leg weakness
  • Severe inflammation of the vertebrae, stiffening of the joints and ligaments, or scoliosis
  • Pacemaker or implanted defibrillator
  • Underlying systemic or visceral disease which might be causing back pain
  • Osteoporosis
  • Cancer within 5 years prior to study entry. Participants with non-melanoma skin cancer are not excluded.
  • Unexplained weight loss or recent unexplained fever
  • Bleeding disorder or current use of anticoagulant medication
  • Any disabling medical condition
  • Major organ transplantation
  • Current use of systemic corticosteroids
  • Current use of immunosuppressive medications
  • Current use of intravenous drugs
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainBack PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • David Eisenberg, PhD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 12, 2005

Study Start

July 1, 2004

Study Completion

April 1, 2006

Last Updated

December 11, 2009

Record last verified: 2009-12