Workpackages

Wp3 Service validation

Objectives and approach

Objectives : real market validation of the service in two target groups; one for patients with work related neck shoulder pain and one for patients with a chronic whiplash.

Approach: Usability for patients and professionals, clinical and economic benefits for all key actors in the value chain will be demonstrated. In the first three months the protocols for the trials will be developed and METC approvals will be arranged. The trial will start in T0+4 and inclusion of subjects will last till T0+14. Within this time span the total number of subjects included will be at least 100. The last two months of this WP data analysis and reporting will be finalised.

Tasks; responsible partner

T3.1 Protocol definition; RRD

This concerns the development of the protocols, the standardization of the outcome measures among the professionals performing the trials and supporting METC approvals.

T3.2 Quality monitoring; RRD

This task concerns the overall monitoring of the validation trials across the service centres. Monitoring consists of proper in- and exclusion, quality check on the data including missing values, number of subjects included with respect to the time schedule and loss to follow up monitoring.

T3.3. Clinical validation in subjects with work related disorders; UGOT

UGOT and RRD will include at least 20-25 cases with work related neck shoulder problems; half of them are randomly admitted to the myofeedback service whereas the other half will be admitted to the control group. All subjects will be tested before, at four weeks and at 3 months follow up on

3.3.1. User satisfaction and acceptability of the service will be measured by questionnaires developed according the Technology Acceptance Model (TAM). This model suggests that behavioural intention toward usage is indirectly preceded by perceived usefulness and perceived ease of use. This will answer the question whether patients and professionals are ready to adopt the service and from this recommendations for adaptations needed for large scale commercialisation will be derived.

3.3.2. Clinical outcome. The main outcome parameters are pain and disability which will be assessed using questionnaires and pain pressure threshold (PPT). As secondary outcome parameters muscle activation patterns measured by means of surface EMG of the trapezius muscle during the performance of computer tasks as well as psychological and social cognitions measured with validated questionnaires will be used,.

3.3.3. Economic outcome by estimating the variable medical costs per patients (like time invested by health care professionals), the variable technical costs per patient (like costs for data transmission and helpdesk) and the fixed cost for the service (like technology needed).

T3.4. Clinical Validation in patients with a chronic Whiplash; RRD

RUB, UGent will each include 20 and RRD 25 cases with a chronic Whiplash; half of them are randomly admitted to the myofeedback service whereas the other half will be admitted to the control group. All subjects will be tested before, at four weeks and at 3 months follow up using the same outcome instruments as described in T3.3.

Task 3.5. Data analysis; RRD

In this task the data of the validation trials will be analyses and reported. Data analysis will be performed for both trials separately for all outcome parameters but also together for common outcome parameters.

Deliverables

D3.01 Protocol for clinical validation (T0+4)

D3.02 Quality of the trials (T0+16)

D3.03 Draft and Final report describing the clinical validation results for patients with work related disorders (T0+ 9 and T0+18)

D3.04 Draft and Final report describing the Clinical validation results for patients with whiplash (T0+9 and T0+18)

Contribution to Project Objectives

WP3 is the core of the project. From the results of the trials, crucial information on the service efficacy will be finally available together with a univocal knowledge regarding costs and efforts necessary to the health care systems to provide the service. These results are of fundamental importance for the elaboration of the deployment report.