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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Counseling
Exercise and counseling
Control group
Sponsored by
UKK Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring exercise, counseling, movement control, fear avoidance

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UKK Institute for Health Promotion Reserach

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Exercise

Counseling

Exercise and counseling

Control group

Arm Description

Participants in the control group only participate in study measurements.

Outcomes

Primary Outcome Measures

Intensity of LBP for past month assessed by Visual Analog Scale
Changes in the intensity of LPB at the given time frame

Secondary Outcome Measures

Movement control impairment
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.
Fear-avoidance beliefs questionnaire
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).
Objective assessment of physical activity with accelerometer
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.

Full Information

First Posted
October 28, 2011
Last Updated
January 21, 2016
Sponsor
UKK Institute
Collaborators
Tampere University Hospital, Finnish Institute of Occupational Health, University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01465698
Brief Title
Prevention of Chronic Low Back Pain in Female Nurses
Acronym
NURSE-RCT
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UKK Institute
Collaborators
Tampere University Hospital, Finnish Institute of Occupational Health, University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
exercise, counseling, movement control, fear avoidance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Counseling
Arm Type
Experimental
Arm Title
Exercise and counseling
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Arm Description
Participants in the control group only participate in study measurements.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Neuromuscular exercise, Control of lumbar neutral zone, Physical fitness
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Other Intervention Name(s)
Behavioral counseling, Fear avoidance beliefs, Physical activity promotion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and counseling
Other Intervention Name(s)
Neuromuscular exercise, Control of lumbar neutral zone, Physical fitness, Behavioral counseling, Fear avoidance beliefs, Physical activity promotion
Intervention Description
Participants take part in both exercise and counseling as described in the separate interventions.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
No intervention
Intervention Description
Participants in the control group take part only in measurements of NURSE-RCT.
Primary Outcome Measure Information:
Title
Intensity of LBP for past month assessed by Visual Analog Scale
Description
Changes in the intensity of LPB at the given time frame
Time Frame
Baseline, 6, 12 and 24 months follow-up
Secondary Outcome Measure Information:
Title
Movement control impairment
Description
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.
Time Frame
Baseline, 6, 12 and 24 months follow-up
Title
Fear-avoidance beliefs questionnaire
Description
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).
Time Frame
Baseline, 6, 12 and 24 months follow-up
Title
Objective assessment of physical activity with accelerometer
Description
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.
Time Frame
Baseline, 6, 12 and 24 months follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaana H Suni, DSc, Docent
Organizational Affiliation
UKK Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKK Institute for Health Promotion Reserach
City
Tampere
ZIP/Postal Code
33500
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33413235
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.
Results Reference
derived
PubMed Identifier
30558592
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.
Results Reference
derived

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Prevention of Chronic Low Back Pain in Female Nurses

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