Prevention of Chronic Low Back Pain in Female Nurses (NURSE-RCT)

January 21, 2016 updated by: Jaana Suni, UKK Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33500
        • UKK Institute for Health Promotion Reserach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Behavioral: Exercise

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 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

Other Names:
  • Physical fitness
  • Neuromuscular exercise
  • Control of lumbar neutral zone
Experimental: Counseling
Behavioral: Counseling
Counseling 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.
Other Names:
  • Behavioral counseling
  • Fear avoidance beliefs
  • Physical activity promotion
Experimental: Exercise and counseling
Behavioral: Exercise and counseling
Participants take part in both exercise and counseling as described in the separate interventions.
Other Names:
  • Physical fitness
  • Behavioral counseling
  • Neuromuscular exercise
  • Control of lumbar neutral zone
  • Fear avoidance beliefs
  • Physical activity promotion
Other: Control group
Participants in the control group only participate in study measurements.
Other: Control group
Participants in the control group take part only in measurements of NURSE-RCT.
Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6, 12 and 24 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement control impairment
Time Frame: Baseline, 6, 12 and 24 months follow-up
Changes in active movement control of the lower back will be assessed with six tests of movement control dysfunction introduced by Luomajoki et al.(2007, 2008, 2010). The test results have shown a significant difference between patients with LBP and healthy controls, as well as between patients with acute and chronic, and chronic and subacute LBP. Reliability of the tests has been established as well as responsiveness to physical exercise. For a subsample of participants the test performances will be videotaped to ensure the objectivity of the assessments.
Baseline, 6, 12 and 24 months follow-up
Fear-avoidance beliefs questionnaire
Time Frame: Baseline, 6, 12 and 24 months follow-up
Changes in fear-avoidance behaviour will be assed with the specific questionnaire on fear-avoidance beliefs (FABQ) addressing the behavior in both work and leisure (Waddel ym. 1993).
Baseline, 6, 12 and 24 months follow-up
Objective assessment of physical activity with accelerometer
Time Frame: Baseline, 6, 12 and 24 months follow-up
Objective assessment of physical activity is conducted at the given time points during seven consecutive days by accelerometers (Hookie AM 20 Activity Meter, Hookie Technologies Ltd, Espoo. Participants wear accelerometers at all times except for sleeping. Changes in physical activity patterns are investigated: total amount of sitting, light physical activity, moderate physical activity and strenuous physical activity.
Baseline, 6, 12 and 24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UKK Institute

Collaborators

University of Zurich
Tampere University Hospital
Finnish Institute of Occupational Health

Investigators

  • Principal Investigator: Jaana H Suni, DSc, Docent, UKK Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R08157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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