Clinical trial NCT01465698: Prevention of Chronic Low Back Pain in Female Nurses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: exercise
counseling
movement control
fear avoidance
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Finnish Institute of Occupational Health
name: University of Zurich
First posted: 2011-11-06
Enrollment: 219
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* woman aged 40 to 55
* working at one's current nursing job at least for 12 months
* intensity of LBP on Visual Analog Scale (VAS) has been greater than 20mm (scale 0-100) during the last month

Exclusion Criteria:

* serious former back injury (fracture, surgery, discus prolapse)
* chronic low back symptoms i.e. time when last experienced no low back pain is longer than six months
* pregnant or recent delivery (\<12months)
* general health problems prevent moderate exercise
* body mass index \>35

Primary outcomes:
measure: Intensity of LBP for past month assessed by Visual Analog Scale
timeFrame: Baseline, 6, 12 and 24 months follow-up
Secondary outcomes:
measure: Movement control impairment
timeFrame: Baseline, 6, 12 and 24 months follow-up
measure: Fear-avoidance beliefs questionnaire
timeFrame: Baseline, 6, 12 and 24 months follow-up
measure: Objective assessment of physical activity with accelerometer
timeFrame: Baseline, 6, 12 and 24 months follow-up
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: UKK Institute for Health Promotion Reserach
Study officials:
affiliation: UKK Institute
name: Jaana H Suni, DSc, Docent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suni JH, Virkkunen T, Husu P, Tokola K, Parkkari J, Kankaanpaa M. Reliability and construct validity of the modified Finnish version of the 9-item patient health questionnaire and its associations within the biopsychosocial framework among female health-care workers with sub-acute or recurrent low back pain. BMC Musculoskelet Disord. 2021 Jan 7;22(1):37. doi: 10.1186/s12891-020-03832-y.
citation: Suni JH, Kolu P, Tokola K, Raitanen J, Rinne M, Taulaniemi A, Parkkari J, Kankaanpaa M. Effectiveness and cost-effectiveness of neuromuscular exercise and back care counseling in female healthcare workers with recurrent non-specific low back pain: a blinded four-arm randomized controlled trial. BMC Public Health. 2018 Dec 17;18(1):1376. doi: 10.1186/s12889-018-6293-9.