Low Back PainNURSE-RCTNCT01465698
Prevention of Chronic Low Back Pain in Female Nurses
A study testing Exercise, Counseling and Exercise and counseling in people with Low Back Pain, run by UKK Institute at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise, Counseling and Exercise and counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Exercise, Counseling, Exercise and counseling, Control group
- Keywords
- exercise, counseling, movement control, fear avoidance
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Neuromuscular exercise, Control of lumbar neutral zone, Physical fitness
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
CounselingBehavioural
Also called Behavioral counseling, Fear avoidance beliefs, Physical activity promotion
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.
Exercise and counselingBehavioural
Also called Neuromuscular exercise, Control of lumbar neutral zone, Physical fitness, Behavioral counseling
Participants take part in both exercise and counseling as described in the separate interventions.
Control groupOther
Also called No intervention
Participants in the control group take part only in measurements of NURSE-RCT.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Counseling | Experimental | Not described Receives: Behavioral: Counseling |
| Exercise and counseling | Experimental | Not described Receives: Behavioral: Exercise and counseling |
| Control group | Other | Participants in the control group only participate in study measurements. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of LBP for past month assessed by Visual Analog Scale
Changes in the intensity of LPB at the given time frame
Measured: Baseline, 6, 12 and 24 months follow-up
Secondary outcomes (3)
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.
Measured: Baseline, 6, 12 and 24 months follow-up
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).
Measured: Baseline, 6, 12 and 24 months follow-up
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.
Measured: Baseline, 6, 12 and 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Finnish Institute of Occupational Health, University of Zurich
- Responsible party
- Principal investigator, Jaana Suni, UKK Institute
- Investigators
- Jaana H Suni, DSc, Docent, Principal investigator, UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465698
- Sponsor's protocol ID
- R08157
- Acronym
- NURSE-RCT
- Status last verified
- Jan 2016
- First submitted
- 28 Oct 2011
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37466018Suni 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.
PubMed 33413235Suni 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.
PubMed 30558592
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01465698
- Acronym / sponsor ID
- NURSE-RCT / R08157
- Conditions
- Low Back Pain
- Keywords
- exercise, counseling, movement control, fear avoidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Finnish Institute of Occupational Health, University of Zurich
- Study start
- Nov 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Counseling | Experimental | Behavioral: Counseling |
| Exercise and counseling | Experimental | Behavioral: Exercise and counseling |
| Control group | Other | Other: Control groupParticipants in the control group only participate in study measurements. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Neuromuscular exercise, Control of lumbar neutral zone, Physical fitnessThe 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 | Behavioural | Exercise |
| CounselingAlso: Behavioral counseling, Fear avoidance beliefs, Physical activity promotionCounseling 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. | Behavioural | Counseling |
| Exercise and counselingAlso: Neuromuscular exercise, Control of lumbar neutral zone, Physical fitness, Behavioral counselingParticipants take part in both exercise and counseling as described in the separate interventions. | Behavioural | Exercise and counseling |
| Control groupAlso: No interventionParticipants in the control group take part only in measurements of NURSE-RCT. | Other | Control group |
Primary outcome
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
3 secondary outcomes
Movement control impairment
Time frame: Baseline, 6, 12 and 24 months follow-up
Fear-avoidance beliefs questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Derived from this study: PubMed 37466018Kolu 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.
- Derived from this study: PubMed 33413235Suni 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.
- Derived from this study: PubMed 30558592Suni 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaana H Suni, DSc, Docent principal investigator
UKK Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Counseling and Exercise and counseling in people with Low Back Pain, run by UKK Institute at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of LBP for past month assessed by Visual Analog Scale (time frame: Baseline, 6, 12 and 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465698, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.