NCT00502619

Brief Summary

The purpose of this research proposal is to conduct a feasibility study to determine the viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back pain (CLBP). To test this novel approach, subjects enrolled from a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS) will undergo acupuncture plus low intensity treadmill walking exercise. Preliminary data regarding subject compliance, self-report of function, pain control, ambulatory activity, and exercise capacity will be collected to assess the response to this combined acupuncture/treadmill exercise protocol. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 low-back-pain

Timeline
Completed

Started Sep 2007

Typical duration for phase_1 low-back-pain

Geographic Reach
1 country

1 active site

Status
terminated

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 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2011

Enrollment Period

2.3 years

First QC Date

July 16, 2007

Last Update Submit

August 2, 2011

Conditions

Low Back Pain

Keywords

Low back painacupuncturetreadmill exercise

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measures are: (1) Numeric Pain Scale, (2) Oswestry Disability Index II, (3) fitness level determined by treadmill exercise, and (4) free-range ambulatory activity using step activity monitors.

    16 weeks

Secondary Outcomes (1)

  • Self-reports, including function, depression, anxiety, and sleep; a physical performance test battery.

    16 weeks

Study Arms (1)

Acupuncture plus Treadmill Exercise

EXPERIMENTAL

Acupuncture plus Treadmill Exercise

Procedure: AcupunctureOther: Treadmill Exercise

Interventions

AcupuncturePROCEDURE

A specific regimen of acupuncture sites will be needled twice weekly for eight weeks and once weekly for a subsequent eight weeks.

Acupuncture plus Treadmill Exercise
Treadmill ExerciseOTHER

After the first four weeks of acupuncture treatments, subjects will initiate a three times per week treadmill program, which will continue for a total of 12 weeks in conjunction with the acupuncture treatments.

Acupuncture plus Treadmill Exercise

Eligibility Criteria

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

You may qualify if:

  • Veterans eligible for this study are men or women between 25 and 65 years old with non-malignant low back pain greater than 6 months duration and pain scores greater than 4 (on a Numeric Pain Scale of 0 = No Pain and 10 = Worst Imaginable Pain) on most days out of the preceding month.
  • Eligible subjects will also need to be able to tolerate 3 minutes walking at a rate of 0.5 miles per hour on a horizontal surface.

You may not qualify if:

  • Inability to provide informed consent
  • Diagnosis of dementia
  • Severe depression (Beck Depression Inventory score \> 30), suicidality, or untreated mental illness
  • Severe anxiety (Beck Anxiety Inventory score \> 30)
  • Evidence of current substance abuse or alcoholism on the TICS
  • Ongoing litigation related to the low back pain complaint
  • Pregnancy or intent to become pregnant during time of study
  • Ambulation requiring an assistive device
  • Neurological, orthopedic, or other conditions impairing ambulation that would affect exercise safety
  • Progressive neurological changes, altered sensation, or a history of cauda equina syndrome
  • Pain below the knee that limits ambulation
  • Lower extremity amputation proximal to the toes
  • Low back pain problem requiring surgical intervention or impending surgery
  • A history of lumbar vertebral fracture; and

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VAMC

Baltimore, Maryland, 21201, United States

Location

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

  • Robert A Lavin, M.D.

    VA Maryland Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 4, 2011

Record last verified: 2011-07

Locations

US(1)