Plain English Summary
Background and study aims
There is proof that the degree of agreement (inter-rater reliability) of Delitto's classification-based system for low back pain is moderate for physical therapists who are familiar with the classification system and the reliability is better in patients with a clear classification than in those with an unclear classification. This study aims to find out the inter-rater reliability of Delittos classification-based treatment for patients with low back pain.
Who can participate?
Adult patients with low back pain can participate in this study.
What does the study involve?
Patients were examined twice on the same day by two of three therapists with different levels of familiarity with the system. Patients were classified into one of four groups. The physical therapists were blind to the other's classification decision. To quantify the inter-rater reliability, percentages of agreement was calculated.
What are the possible benefits and risks of participating?
There are no benefits from taking part in our study. There were hardly any risks for the patients.
Where is the study run from?
Patients were recruited in the Medical Back Neck Centre, an outpatient private practice in the Hague, Netherlands.
When is the study starting and how long is it expected to run for?
Patients were recruited from April 2009 to December 2010.
Who is funding the study?
Information not provided at time of registration.
Who is the main contact?
Dr Adri Apeldoorn
a.apeldoorn@vumc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Adri Apeldoorn
ORCID ID
Contact details
van der Boechorststraat 7
Amsterdam
1081BT
Netherlands
+31 (0)627223692
a.apeldoorn@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Inter-rater reliability of a modified version of Delitto's classification-based system for low back pain: an observational study
Acronym
Study hypothesis
To examine:
1. the inter-rater reliability of Delittos classification-based treatment system for patients with low back pain.
2. the influence of different levels of familiarity with the system.
3. the inter-rater reliability of algorithm decisions in patients who clearly fit into a subgroup (clear classifications) and who do not (unclear classifications).
Ethics approval
Medical Committee of the VU University Medical Centre in Amsterdam, 02/04/2008, reg. 2008\5
Study design
Observational single centre
Primary study design
Observational
Secondary study design
Other
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low back pain
Intervention
Patients were examined twice on the same day by two of three participating physical therapists with different levels of familiarity with the system. Patients were classified into one of four classification groups. The physical therapists were blind to the other's classification decision. To quantify the inter-rater reliability, percentages of agreement and Cohens kappa were calculated.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The prevalence of each of the four classifications was calculated for the three participating physical therapists.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2009
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Low back pain as the primary complaint
2. With or without associated leg pain
3. Age between 18 and 65 years
4. Ability to read and write Dutch
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
Known or suspected serious low back pathology (e.g., cauda equina compression, fractures, severe radiculopathy, spondylolisthesis [grade 2 or more]), serious other diseases (e.g., metastases, AIDS, cerebrovascular accident), psychopathology, currently pregnant or given birth in the past 3 months and an inability to demonstrate any low back pain symptoms during mechanical examination
Recruitment start date
01/04/2009
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
van der Boechorststraat 7
Amsterdam
1081BT
Netherlands
Sponsor information
Organisation
EMGO+ Institute for Health and Care Research, VU University Medical Center Amsterdam (Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081BT
Netherlands
+31 (0)627223692
a.apeldoorn@vumc.nl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
EMGO + Institute for Health and Care Research, VU University Medical Center Amsterdam (Netherlands) no additional funding required
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary