|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00376350 |
|
Date of registration:
|
12/09/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Dose of Spinal Manipulation for Chronic Low Back Pain
|
|
Scientific title:
|
Dose-Response/Efficacy of Manipulation for Chronic LBP |
|
Date of first enrolment:
|
March 2007 |
|
Target sample size:
|
400 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00376350 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Mitchell Haas, DC, MA |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Western States |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Current episode of low back pain
- mechanical origin
- Threshold low back pain level
Exclusion Criteria:
- Contraindications to spinal manipulation or massage
- Complicating conditions that could confound clinical outcome
- Prophylactic use of prescription medication
- Health-related litigation, claims, or disability compensation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Low Back Pain
|
|
Intervention(s)
|
|
Procedure: Light Massage
|
|
Procedure: Pulsed Ultrasound
|
|
Procedure: Spinal Manipulation
|
|
Primary Outcome(s)
|
|
Modified Von Korff Disability Scale
[Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks]
|
|
Modified Von Korff Pain Scale for low back pain
[Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks]
|
|
Secondary Outcome(s)
|
|
Bias monitoring
[Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks]
|
|
Disability days
[Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks]
|
|
Fear avoidance beliefs
[Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks]
|
|
General health status/QoL
[Time Frame: baseline 2; 12, 24, 39, 52 weeks]
|
|
Healthcare utilization
[Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks]
|
|
Low back pain unpleasantness
[Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks]
|
|
Objective measures
[Time Frame: Baseline 2, 6 wk]
|
|
Pain days
[Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks]
|
|
Patient satisfaction
[Time Frame: 12 wk]
|
|
Secondary ID(s)
|
|
U01 AT001908
|
|
U01AT001908
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|