Clinical Trials Directory

Trials / Completed

CompletedNCT01465698

Prevention of Chronic Low Back Pain in Female Nurses

Effectiveness and Financial Feasibility of Neuromuscular Exercise and Counselling Interventions on Pain, Movement Dysfunction, and Fear-avoidance Behaviour in Female Nurses With Non-specific Low Back Pain

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
219 (actual)
Sponsor
UKK Institute · Academic / Other
Sex
Female
Age
40 Years – 55 Years
Healthy volunteers
Not accepted

Summary

NURSE-RCT is a randomized controlled trial which aims at prevention of evolution of chronic low back pain (LBP) and related disability in female nurses. The study investigates the effectiveness and financial feasibility of six months neuromuscular training and counselling, and their combination on LBP, movement dysfunction and fear-avoidance behaviour. The target for neuromuscular training is to reduce movement dysfunction and motor control impairments, caused by trauma and subfailure injuries of spinal ligaments. Training aims at enhancement of motor control of lumbar neutral zone in different positions and movements, balance, coordination, trunk muscle endurance and leg strength. The target for counselling is change in attitudes and behaviour, which help to reduce the fear of pain and encourage to physical activity and other physical tasks. The hypothesis is that together neuromuscular exercise and counselling have a stronger influence on LBP, movement dysfunction and fear-avoidance behaviour than either used alone. Assessments of effectiveness will be conducted after six, 12, and 24 months of the beginning of interventions.

Detailed description

Musculoskeletal disorders are the main reason for work absenteeism and early retirement of nursing stuff, low back pain (LBP) being the leading cause. When compared to other communal staff in Finland, disability pensions are granted earlier to nursing stuff, the average age being 56 years. NURSE-RCT is a multidisciplinary study combining the most recent biomechanical and behavioral theories aimed to prevent evolution of chronic LBP. NURSE-study is a randomized controlled trial aiming at prevention of chronic LBP and related functional disability. Volunteers, female nurses (n\~1200) from wards with bed patients of two geriatric hospitals and the university central hospital in Tampere, Finland will be invited to participate in the study. Each participant (n=160) will be randomized into one of the four study groups after the eligibility has been determined. A method of sequentially numbered sealed envelopes will be used to assign participants into study groups. The main target for exercise intervention is to restore impairments in movement control. First, the participants need to learn the proper technique of each exercise, second to achieve movement control of lumbar neutral zone in each exercise, and finally to increase the challenge of exercises for balance, coordination, muscular endurance and strength. Target dose for exercise is twice a week, 60 minutes per session for six months. The objective of counseling is to change participants' understanding of LBP towards less fearful and negative beliefs, and to provide encouragement for usual daily activities, including physical activity. Advice on nursing tasks that are strenuous for low back is aimed to improve awareness of injury risk and provide examples of proper postures and movements. Target dose for counseling is 10 sessions lasting for 45 minutes. Interventions will take place in facilities close to participants' work sites. The financial feasibility of the effects of the interventions is calculated by using the Potential Model,\[www.miljodata.se\],which was created to calculate the financial feasibility of work health related measures. It differs from typical health economic cost-benefit analyses in the sense that it is aimed at simulating the economic consequences of an investment from a business point of view. In addition to the immediate real losses and sickness absences, the indirect financial consequences like effects on over time work are taken into account. The rational of this study is to discover whether neuromuscular exercise and cognitive behavioral counseling are effective and economically feasible in reducing LBP and its' recurrence, and thus preventing chronic LBP, early retirement and disability pensions.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExerciseThe main target for exercise intervention is to restore impairments in movement control. First, the participants need to learn the proper technique of each exercise, second to achieve movement control of lumbar neutral zone in each exercise, and finally to increase the challenge of exercises for balance, coordination, muscular endurance and strength. Target dose for exercise is twice a week, 60 minutes per session for six months. The neuromuscular exercise program is progressive including three different performance levels. During the first eight weeks, the supervised exercise sessions will take place twice a week. The next 16 weeks the participants have one instructed weekly session, and they exercise once a week at home with help of a DVD or booklet produced for the study
BEHAVIORALCounselingCounseling is conducted according cognitive-behavioral principles. Fear-avoidance model is implemented using problem based learning. The objective is to change participants' understanding of LBP towards less fearful and negative beliefs, and to provide encouragement for usual daily activities, including physical activity. Advice on nursing tasks that are strenuous for low back is aimed to improve awareness of injury risk and provide examples of proper postures and movements. The target is that participants in counseling groups attend 10 sessions each lasting 45 minutes. During the first four weeks the groups meet every second week, and after that once a month up to six months. Participants will receive workbooks to enhance problem-based learning.
BEHAVIORALExercise and counselingParticipants take part in both exercise and counseling as described in the separate interventions.
OTHERControl groupParticipants in the control group take part only in measurements of NURSE-RCT.

Timeline

Start date
2011-11-01
Primary completion
2016-01-01
Completion
2016-01-01
First posted
2011-11-07
Last updated
2016-01-22

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT01465698. Inclusion in this directory is not an endorsement.