Prevention of Chronic Low Back Pain in Female Nurses
NURSE-RCT
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
1 other identifier
interventional
219
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Nov 2011
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 22, 2016
January 1, 2016
4.2 years
October 28, 2011
January 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intensity of LBP for past month assessed by Visual Analog Scale
Changes in the intensity of LPB at the given time frame
Baseline, 6, 12 and 24 months follow-up
Secondary Outcomes (3)
Movement control impairment
Baseline, 6, 12 and 24 months follow-up
Fear-avoidance beliefs questionnaire
Baseline, 6, 12 and 24 months follow-up
Objective assessment of physical activity with accelerometer
Baseline, 6, 12 and 24 months follow-up
Study Arms (4)
Exercise
EXPERIMENTALCounseling
EXPERIMENTALExercise and counseling
EXPERIMENTALControl group
OTHERParticipants in the control group only participate in study measurements.
Interventions
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
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.
Participants take part in both exercise and counseling as described in the separate interventions.
Participants in the control group take part only in measurements of NURSE-RCT.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UKK Institutelead
- Tampere University Hospitalcollaborator
- Finnish Institute of Occupational Healthcollaborator
- University of Zurichcollaborator
Study Sites (1)
UKK Institute for Health Promotion Reserach
Tampere, 33500, Finland
Related Publications (3)
Kolu P, Suni JH, Tokola K, Raitanen J, Rinne M, Taulaniemi A, Husu P, Kankaanpaa M, Parkkari J. Neuromuscular exercise and counseling for treating recurrent low back pain in female healthcare workers-Findings from a 24-month follow-up study of a randomized controlled trial. Scand J Med Sci Sports. 2023 Nov;33(11):2239-2249. doi: 10.1111/sms.14451. Epub 2023 Jul 19.
PMID: 37466018DERIVEDSuni 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.
PMID: 33413235DERIVEDSuni 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.
PMID: 30558592DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaana H Suni, DSc, Docent
UKK Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Reseracher
Study Record Dates
First Submitted
October 28, 2011
First Posted
November 7, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 22, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share