Low Back Pain Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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