Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02047669
Other study ID # IRMA09
Secondary ID
Status Completed
Phase N/A
First received January 26, 2014
Last updated September 1, 2015
Start date March 2014
Est. completion date July 2014

Study information

Verified date September 2015
Source National Research Centre for the Working Environment, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

- Laboratory technician

- Pain intensity >= 3 (scale of 0-10)

- Pain duration >= 3 months

- Pain frequency >= 3 days per week

Exclusion Criteria:

- life threatening disease

- pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Biopsychosocial

Reference


Locations

Country Name City State
Denmark National Research Centre for the Working Environment Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
National Research Centre for the Working Environment, Denmark University of Southampton, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other WAI Work ability index questionnaire change from baseline to week 10 No
Other Fear Avoidance Fear avoidance is evaluated by the Fear Avoidance Beliefs questionnaire (FABQ) by Waddell et al. at baseline and follow-up. Briefly, the FABQ is a two-part questionnaire. The first part consists of five questions/statements about pain and physical activity and the second part consists of 11 questions/statements about how work affects the participants' perception of pain. Each question is scored from 0-5 ranging from completely disagree (0) to completely agree (5). change from baseline to week 10 No
Other Muscle function Muscle strength, function and tenderness of the shoulder, arm, wrist/hand is assessed by maximal isometric voluntary contractions in a custom-built dynamometer (Bofors Elektronik, Karlskoga, Sweden) setting and by pressure-pain threshold testing (PPT). Also rate of force development (RFD), force steadiness (FS), force precision (FP) and fatigue (F) are measured by using custom-made MATLAB programs. The strength tests are a part of an extensive physical examination by trained (and blinded) medical professionals at baseline and follow-up. Muscle activation level is measured by surface electromyography (EMG) (Nexus Mark 10, Mindmedia, Netherlands) on the forearm extensors, shoulder external rotator (Infraspinatus Mm.) and descending part of the trapezius muscle. Further, surface EEG (Nexus Mark 10, Mindmedia, Netherlands) will measure global brain activity during pre- and post testing by using a single a single sensor placement on the forehead (Fpz). change from baseline to week 10 No
Primary Pain intensity The change in "pain intensity during the last week" (average value of back, neck, shoulder, elbow and hand) from baseline to 10 week follow-up between the individually tailored biopsychosocial group and reference group. 2-way analysis of variance with repeated measures will be used, with time, group and time x group as fixed factors and subject as random factor. Analyses will be controlled for pain intensity at baseline. change from baseline to week 10 No
Secondary Stress Cohens perceived stress scale change from baseline to week 10 No
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A