e-Exercise: blended physical therapy for patients with non-specific low back pain
| ISRCTN | ISRCTN94074203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94074203 |
| Secondary identifying numbers | SVB/RAAK.PRO02.063 |
- Submission date
- 17/07/2018
- Registration date
- 20/07/2018
- Last edited
- 01/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Low back pain is a common cause of disability and can cause pain and limitations in daily functioning such as shopping or working. In some people the low back pain lasts for a long time, or returns on a regular basis. A patient can do a lot to relieve his/her own low back pain, for example by doing exercises or being physically active.
The extent to which a patient recovers from low back pain depends on how the patient deals with low back pain. A physical therapist is able to provide a patient with guidance and support, but it is often difficult for patients to adhere to their advice completely.
An alternative to this is the use of an e-Exercise smartphone app, which can support the patients' adherence and improve self-management by providing information about low back pain and what the patient can do to promote recovery. In addition, the app offers support aimed at resuming daily activities, exercises and being physically active.
The aim of this study is to investigate whether the result of physical therapy can be improved by using the e-Exercise smartphone app.
Who can participate?
Males and females aged 18 years or older having non-specific low back pain can participate in this study
What does the study involve?
The study compares two different treatment programs. One group will receive physical therapy treatment in combination with the e-Exercise smartphone app. The other group will receive physical therapy without the app. Participants will be asked to complete questionnaires during and after the treatment (24 months follow-up) to assess the effects of the treatment.
What are the possible benefits and risks of participating?
It is expected that there will be benefits to participants in both groups, through improved physical function and reduced pain intensity. There are no known risks to participants of taking part.
Where is the study run from?
The trial is run from the University Medical Centre (UMC) Utrecht, the Netherlands
A total of 50 physical therapy practices throughout the Netherlands will be taking part in the study and treat the included patients with low back pain.
When is the study starting and how long is it expected to run for?
November 2017 to October 2021
Who is funding the study?
Dutch Organization for Scientific Research (NWO) (The Netherlands)
Who is the main contact?
Martijn Pisters
m.f.pisters@umcutrecht.nl
Contact information
Scientific
Dept. of Rehabilitation, Physiotherapy Science and Sport
UMC Utrecht, Utrecht University
Postbus 85500
Utrecht
3508 GA Utrecht
Netherlands
Public
Dept. of Rehabilitation, Physiotherapy Science and Sport
UMC Utrecht, Utrecht University
Utrecht
3508 GA Utrecht
Netherlands
Public
Dept. of Rehabilitation, Physiotherapy Science and Sport
UMC Utrecht, Utrecht University
Utrecht
3508 GA Utrecht
Netherlands
Study information
| Study design | Interventional prospective cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN94074203_PIS_19Jul18.pdf |
| Scientific title | The short-term (3 months) effectiveness on physical functioning, and the long-term (24 months) cost-effectiveness, of a personalized stratified blended care intervention (e-Exercise LBP) in comparison with usual physical therapy in patients with non-specific LBP. |
| Study acronym | e-Exercise LBP |
| Study objectives | This study aims to examine the short-term (3 months) effectiveness on physical functioning, and the long-term (24 months) cost-effectiveness, of a personalized stratified blended care intervention (e-Exercise LBP) in comparison with usual physical therapy in patients with non-specific LBP. |
| Ethics approval(s) | Medical Ethical Board of the University Medical Centre Utrecht, 11/04/2018, 18/085 |
| Health condition(s) or problem(s) studied | Non-specific low back pain |
| Intervention | Randomisation is done at the level of the participating physical therapy practices. Participating primary care physical therapy practices will be randomized by an independent researcher to either the intervention group or the usual care (control) group by a computer-generated random sequence table generated using SPSS. Through cluster randomization, the possibility of professionals offering both experimental and usual care intervention is avoided and/or that professionals who offer the experimental or usual care intervention within one physical therapy practice will influence each other (contamination-effect). Participants in the intervention group are stratified into 3 different groups based on the risk to develop persistent low back pain. All participants in the intervention group are treated using a blended care approach (e-Exercise), in which online e-health modules are an integral part of face-to-face physical therapy treatment - face-to-face care by a physical therapist, supported by a smartphone app. The stratification of the patients in this group means that the support of the app can differ based upon the risk profile of the patient - e-Exercise is tailored to the patients’ individual needs, based on their prognostic risk for developing persistent LBP, as determined by the Keele STarT Back Screening Tool. The e-Exercise low back pain program is an app containing information and self-management modules, a home-based exercise module and offers remote support to increase adherence to physical activity and exercise recommendations. The online modules consist of (1) video-based LBP self-management information, (2) an individualized home-based exercise program including instruction videos and (3) a physical activity module to maintain or improve patients’ individual level of physical activity, based on the principles of graded activity. The control group receive usual care according to the recommendations of the guideline LBP of the Royal Dutch Association for Physical Therapy (KNGF) without the use of e-health applications. Participants in both groups will be instructed to wear the Activ8 activity monitor for 5 consecutive weeks at baseline and 8 consecutive days at follow-up except during sleeping, showering, bathing or swimming, in order to measure time spent sitting/lying, standing, walking, running and cycling. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Short-term improvement of low-back-related physical functioning assessed using the Oswestry Disability Index version 2.1a at the baseline, after 3 months, after 12 months and after 24 months 2. Long-term reduction of low-back-pain-related costs assessed using 8 retrospective cost questionnaires every 3 months from the baseline to the 24 months follow-up. Cost effectiveness is determined after 12 months and after 24 months, based on patient's healthcare utilisation and (unpaid) productivity losses due to LBP (based on responses to the cost questionnaires). Healthcare utilization will be valued using Dutch standards costs. If these are unavailable, prices reported by professional organizations will be used. Unpaid productivity losses will be valued in accordance with the “Dutch Manual of Costing”. Paid productivity losses comprise of both sickness absence and presenteeism (i.e. reduced productivity while at work). Sickness absence will be valued in accordance with the “Friction Cost Approach” (FCA), with a friction period of 23 weeks and an elasticity of 0.8, using age- and gender-specific price weights. The FCA assumes that production losses are confined to the “friction period” (i.e. time needed to replace a sick worker) and that a 100 percent loss of labor input corresponds with an 80 percent reduction in productivity (i.e. an elasticity of 0.8)(63). The participants’ level of presenteeism will be measured using the “World Health Organization – Work Performance Questionnaire” as well as the “Productivity and Disease Questionnaire”, and valued using age- and gender specific price weights. The costs of e-Exercise LBP will be estimated using a bottom-up microcosting approach. |
| Secondary outcome measures | Current secondary outcome measures as of 26/04/2021: The following will be assessed at the baseline, after 3 months, after 12 months and at the 24 months follow-up: 1. Pain intensity, assessed using the Numeric Pain Rating Scale (NPRS) 2. Physical activity, assessed using Activ8 activity monitor 3. Adherence to prescribed home exercises, assessed using Exercise Adherence Rating Scale (EARS) and Utrecht Home-based Exercise Adherence Questionnaire (UHAQ). EARS is a self-reported questionnaire and UHAQ is an interview-based questionnaire, which will be used by the physical therapist during face-to-face care, to determine qualitative performance of the recommended recommended home exercises and the agreement between recommended home exercises and patient reported adherence 4. Psychological function, assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS) 5. Self-efficacy, assessed using the Generalized Self-Efficacy (GSE) scale 6. Self-management skills, assessed using the Dutch version of the Pain Activation Measure (PAM13-Dutch) 7. Health-related quality of life, assessed using the EQ-5D-5L 8. Number of recurrent low back pain episodes, assessed every 3 months from the baseline until the 24 months follow-up. This is measured using the number of self-reported LBP episodes during the follow-up period (a recurrent LBP episode is defined as return of LBP with a minimum duration of 24 hours with a minimum pain intensity of 3 or more on the NRS since the date of recovery. For recovery, a minimum duration of 4 weeks pain-free is used) Previous secondary outcome measures: The following will be assessed at the baseline, after 3 months, after 12 months and at the 24 months follow-up: 1. Pain intensity, assessed using the Numeric Pain Rating Scale (NPRS) 2. Physical activity, assessed using Activ8 activity monitor 3. Adherence to prescribed home exercises, assessed using Exercise Adherence Rating Scale (EARS) and Utrecht Home-based Exercise Adherence Questionnaire (UHAQ). EARS is a self-reported questionnaire and UHAQ is an interview-based questionnaire, which will be used by the physical therapist during face-to-face care, to determine qualitative performance of the recommended recommended home exercises and the agreement between recommended home exercises and patient reported adherence 4. Psychological function, assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS) 5. Self-efficacy, assessed using the Generalized Self-Efficacy (GSE) scale 6. Self-management skills, assessed using the Dutch version of the Pain Activation Measure (PAM13-Dutch) 7. Health-related quality of life, assessed using the EQ-5D-5L 8. Risk of developing persistent low back pain, assessed using the STarT Back Tool (SBT) 9. Central sensitivity, assessed using the Central Sensitization Inventory (CSI) 10. Usability of the e-Exercise low back pain app, assessed using the System Usability Scale (SUS) 11. Number of recurrent low back pain episodes, assessed every 3 months from the baseline until the 24 months follow-up. This is measured using the number of self-reported LBP episodes during the follow-up period (a recurrent LBP episode is defined as return of LBP with a minimum duration of 24 hours with a minimum pain intensity of 3 or more on the NRS since the date of recovery. For recovery, a minimum duration of 4 weeks pain-free is used) |
| Overall study start date | 01/11/2017 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 208 |
| Total final enrolment | 208 |
| Key inclusion criteria | 1. Applying for physical therapy for LBP 2. Aged 18 years or older 3. Non-specific LBP, defined as pain in the lumbosacral region (sometimes associated with radiating pain to the buttock or leg) in the absence of an identifiable underlying cause 4. Possessing a smartphone or tablet with access to the internet 5. Able to communicate in the Dutch language fluently |
| Key exclusion criteria | 1. Diagnosed with LBP due to a possible specific cause trough medical imaging or a doctor (e.g. osteoporotic fractures, spinal nerve compromise, malignancy, ankylosing spondylitis, canal stenosis, or severe spondylolisthesis) 2. Serious comorbidities (i.e. malignancy, stroke) 3. Pregnant |
| Date of first enrolment | 13/07/2018 |
| Date of final enrolment | 19/12/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrecht
3584CX Utrecht
Netherlands
Sponsor information
Hospital/treatment centre
Heidelberglaan 100
Utrecht
3584 CX Utrecht
Netherlands
| Website | https://www.umcutrecht.nl/nl/ |
|---|---|
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
- Location
- Netherlands
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be valailable upon reasonable request from the principal reseacrher (Martijn Pisters, m.f.pisters@umcutrecht.nl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/07/2018 | 02/04/2019 | No | Yes | |
| Protocol article | protocol | 22/04/2020 | 24/04/2020 | Yes | No |
| Results article | 25/02/2022 | 28/02/2022 | Yes | No | |
| Results article | 24/11/2023 | 27/11/2023 | Yes | No |
Additional files
- ISRCTN94074203_PIS_19Jul18.pdf
- Uploaded 02/04/2019
Editorial Notes
01/12/2023: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2021 to 30/11/2023.
2. The participant level data sharing statement was added.
27/11/2023: Publication reference added.
28/02/2022: Publication reference added.
26/04/2021: The secondary outcome measures have been updated. The secondary outcome measures previously listed as number 8-10 should not be mentioned as secondary outcome measures since they cannot be compared between groups at follow-up measurements. In the study protocol these are mentioned as patient characteristics with the risk of developing persistent low back pain (assessed at baseline using the STarT Back Tool) used to stratify treatment and indicate/describe the risk of participants to develop persistent complaints, and central sensitivity (assessed using the Central Sensitization Inventory) is only used to describe the study population at baseline. Additionally, the usability of the e-Exercise low back pain app, assessed using the System Usability Scale (SUS), is not a patient characteristic but cannot be compared between groups since it is used to evaluate the e-Exercise LBP app and only the intervention arm receives the app in the study.
24/04/2020: Publication reference added.
10/01/2020: The following changes have been made:
1. The intention to publish date has been changed from 31/10/2021 to 31/12/2021.
2. The overall trial end date has been changed from 31/10/2021 to 31/12/2021.
20/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 19/12/2019.
2. The total final enrolment number has been added.
09/12/2019: The target number of participants was changed from 255 to 208.
21/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2019 to 31/12/2019.
2. The target number of participants was changed from 246 to 255.
02/04/2019: The participant information sheet has been uploaded.
