NCT00561652

Brief Summary

As a needed first step prior to a planned full-scale RCT, in order to assess the feasibility of the RCT and refine its design and protocols, we will perform a pilot study with the following objectives:1.To assess whether enough veterans with chronic LBP can be identified, meet eligibility criteria and be randomized to demonstrate that recruitment for a planned full-scale RCT is feasible. 2.To assess whether veterans with chronic LBP will adhere to protocol interventions per study protocol. 3.To assess whether veterans with chronic LBP will complete data collection per study protocol. 4.To obtain estimates of effect sizes and the corresponding standard errors of the primary efficacy outcome measures to estimate the required sample size of a planned full-scale RCT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable 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

First Submitted

Initial submission to the registry

November 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

November 19, 2007

Results QC Date

November 6, 2014

Last Update Submit

January 23, 2015

Conditions

Low Back Pain

Keywords

Low back painChiropracticExerciseVeterans

Outcome Measures

Primary Outcomes (1)

  • Participant Adherence With Education + Exercise Visits

    Number of participants completing at least 3 of 4 education + exercise visits

    12 weeks

Other Outcomes (6)

  • Participant Adherence With Chiropractic Visits

    12 weeks

  • Participant Adherence With "Time and Attention" Visits

    12 weeks

  • Participant Adherence With Prescribed Home Exercise

    12 weeks

  • +3 more other outcomes

Study Arms (2)

Education + exercise

ACTIVE COMPARATOR

Education was provided in four, 1-hour sessions to improve patients' understanding of their back problem, reduce unwarranted concern about serious outcomes, \& empower them to maintain normal activities \& reduce risk of future back problems. Patients were taught that recovery depends on moving \& restoring normal function \& fitness. Patients were shown stretching \& strengthening exercises to perform daily at home to enhance mobility \& increase trunk endurance while minimizing spinal load. At follow-up, therapists reviewed exercise form \& adherence. Participants allocated to no chiropractic care also were scheduled for 10 weekly 10-15 minute sessions to equalize provider attention vs. the group also receiving chiropractic care \& not to provide education, exercise instruction, or therapy.

Behavioral: Education & Exercise

Education + exercise + chiropractic

EXPERIMENTAL

In addition to education \& exercise, all participants in this arm will be assigned chiropractic treatment. A minimum of 4 \& up to 12 treatments will be provided over 6 weeks, based on patient response (i.e. treatments stopped if symptoms resolve). Each treatment visit will last 10-20 minutes. After 6 weeks, if the treating chiropractor determined that the patient's LBP was continuing to improve but hadn't reached therapy goals defined at baseline, the patient could receive up to 12 additional treatments over the next 6 weeks. Chiropractic treatment was delivered following standardized protocols. Treatment consisted of manual therapies, including SMT and mobilization techniques, with the assistance of light soft tissue techniques as indicated to facilitate the SMT.

Behavioral: Education & ExerciseProcedure: Chiropractic treatment (plus Education & Exercise)

Interventions

Education & ExerciseBEHAVIORAL

Education \& Exercise

Education + exerciseEducation + exercise + chiropractic
Chiropractic treatment (plus Education & Exercise)PROCEDURE

Chiropractic treatment (plus Education \& Exercise)

Education + exercise + chiropractic

Eligibility Criteria

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

You may qualify if:

  • Veterans enrolled to receive VA medical care
  • Current low back pain episode present \> 6 weeks.
  • LBP pain score \> 3 on scale of 0-10.
  • LBP classified using the Quebec Task Force (QTF) system as types 1-4 respectively, patients with LBP, stiffness or tenderness, without radiation; with radiation proximal to knee; with radiation distal to knee; or with radiation and \>2 abnormal neurological exam findings.
  • No change in past month in prescription medications affecting musculoskeletal pain.

You may not qualify if:

  • Low back pain classified as QTF type 5-11
  • Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome.
  • Previous lumbar spine surgery, by history and/or screening spine radiograph.
  • Acute vertebral fracture, by history and spine radiograph
  • Self-reported ongoing LBP treatment by other healthcare providers other than stable prescription medications affecting musculoskeletal pain.
  • Infectious and noninfectious inflammatory destructive spine tissue changes, by spine radiograph
  • Self-reported pending/current litigation pertaining to back pain, including workers compensation claims; or pending evaluation of VA service connected rating related to back pain.
  • Clinically significant chronic inflammatory spinal arthritis
  • Self-reported pregnancy
  • Self-reported current substance abuse
  • History of bleeding disorder
  • Known arterial aneurysm near LBP area
  • Possible/confirmed spinal/vertebral infection, by history and spine radiograph
  • Primary or metastatic vertebral malignancy, by history and spine radiograph

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Educational StatusExercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Howard Fink
Organization
Minneapolis VA Medical Center
howard.fink@va.gov
612-467-3304

Study Officials

  • Howard A. Fink, MD MPH

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 21, 2007

Study Start

April 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 10, 2015

Results First Posted

February 10, 2015

Record last verified: 2015-01

Locations

US(1)