search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effect of a cognitive behavioral intervention with or without a Functional Capacity Evaluation on work ability in patients with musculoskeletal pain.


- candidate number10479
- NTR NumberNTR3122
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-okt-2011
- Secondary IDs38523 ABR
- Public TitleEffect of a cognitive behavioral intervention with or without a Functional Capacity Evaluation on work ability in patients with musculoskeletal pain.
- Scientific TitleEffect of a cognitive behavioral intervention with or without a Functional Capacity Evaluation on work ability in patients with musculoskeletal pain.
- ACRONYMWorkability
- hypothesisThe addition of a Functional Capacity Evaluation to a cognitive behavioral intervention will improve work ability, quality of life and self efficacy.
- Healt Condition(s) or Problem(s) studiedCognitive behavior therapy, Chronic pain, Functional capacity evaluation, Work ability
- Inclusion criteria1. Patients with chronic nonspecific musculoskeletal pain;
2. Pain persists for three months of longer;
3. Work absenteeism of six weeks or longer;
4. Age between 18 and 60 years;
5. Referral for treatment by insurance or work physician.
- Exclusion criteria1. Insufficient knowledge of the Dutch language;
2. Medical co-morbidity with significant influence on work ability, like hernias or diagnosed psychiatric illness.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-jul-2013
- Target number of participants70
- InterventionsThe regular intervention consist of six treatment sessions of 45 minutes in 16 weeks time. The patient receives instructions and assignments about how to handle the pain more adequately. Attention will be paid to the principles of chronic pain, improvement of health behaviour, and graded activity to improve the activity level. The program will be given by a physiotherapist or a psychologist and is specifically aimed at individual treatment goals.
In the experimental group the treatment program will be extended with and based on a FCE which consist of a maximum of seven work- and complaints related physical tests. The tests takes two hours two complete.
- Primary outcomeWork ability measured with the Work Ability Index.
- Secondary outcomeQality of life measured with the RAND and self efficacy measured with the Pain SE Questionnaire.
- TimepointsAt the beginning and end of the intervention period.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. S. Meer, van der
- CONTACT for SCIENTIFIC QUERIESMSc. S. Meer, van der
- Sponsor/Initiator Condite, Advies bij ziekteverzuim
- Funding
(Source(s) of Monetary or Material Support)
Condite
- PublicationsN/A
- Brief summaryRationale:
Chronic nonspecific musculoskeletal pain (CMP) can lead to prolonged absence of work and thereby high costs related to work absenteeism and treatment. Cognitive behavioural interventions have demonstrated effectiveness for improvement of work ability. Addition of a Functional Capacity Evaluation (FCE) to a cognitive behavioral intervention can further improve work ability.

Objective:
To measure whether adding a FCE to a cognitive behavioral intervention will improve work ability, quality of life and self efficacy.

Study design:
Randomized controlled trial.

Study population:
Patients with CMP with decreased work ability.

Intervention:
The intervention consist of six treatment sessions of 45 minutes in 16 weeks time. The patient receives instructions and assignments about how to handle the pain more adequately. Attention will be paid to the principles of chronic pain, improvement of health behaviour, and graded activity to improve the activity level. The program will be given by a physiotherapist or a psychologist and is specifically aimed at individual treatment goals. In the experimental group the treatment program will be extended with and based on a FCE which consist of a maximum of seven work- and complaints related physical tests.

Main study parameters/endpoints:
Work ability measured with the Work Ability Index.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risk of the study is negligible. All test are considered safe for the patients and with a low burden.
- Main changes (audit trail)
- RECORD26-okt-2011 - 7-nov-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl