Condition category
Musculoskeletal Diseases
Date applied
03/11/2013
Date assigned
23/01/2014
Last edited
27/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 Delitto’s 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 Delitto’s 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 Cohen’s 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

Publication citations

Additional files

Editorial Notes