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Clinical Trials/NCT01465698
NCT01465698CompletedNot Applicable

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

UKK Institute1 site in 1 country219 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
219
Locations
1
Primary Endpoint
Intensity of LBP for past month assessed by Visual Analog Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Exercise

Experimental

Intervention: Exercise (Behavioral)

Counseling

Experimental

Intervention: Counseling (Behavioral)

Exercise and counseling

Experimental

Intervention: Exercise and counseling (Behavioral)

Control group

Other

Participants in the control group only participate in study measurements.

Intervention: Control group (Other)

Outcomes

Primary Outcomes

Intensity of LBP for past month assessed by Visual Analog Scale

Time Frame: Baseline, 6, 12 and 24 months follow-up

Changes in the intensity of LPB at the given time frame

Secondary Outcomes

  • Movement control impairment(Baseline, 6, 12 and 24 months follow-up)
  • Objective assessment of physical activity with accelerometer(Baseline, 6, 12 and 24 months follow-up)
  • Fear-avoidance beliefs questionnaire(Baseline, 6, 12 and 24 months follow-up)

Investigators

Sponsor
UKK Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaana Suni

Senior Reseracher

UKK Institute

Study Sites (1)

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