|- candidate number||14549|
|- NTR Number||NTR3911|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-mrt-2013|
|- Secondary IDs||T6500 / D3766 / 11-507/C; RVVZ UVIT / METC|
|- Public Title||Online physiotherapy for patients with low back pain.|
|- Scientific Title||Effectiveness and patient satisfaction of online physiotherapy in patients with low back pain|
|- ACRONYM||mijn fysio online|
|- hypothesis||Online physiotherapy treatment using Mijn Fysio Online is as effective as standard physiotherapy in reducing impairments and limitations in patients with low back pain.|
|- Healt Condition(s) or Problem(s) studied||Low back pain (LBP), E-health|
|- Inclusion criteria||1. Patients of 18 years or older with non-specific low back pain;|
2. The patient meets profile 1b, 2a, 2b, 3a of 3b of the Dutch Low-Back Pain Guideline for physiotherapists (KNGF-richtlijn lage-rugpijn);
3. The patient has internet access at their home;
4. The patient is willing to (partial) online treatment;
5. The patient has a good command of the Dutch language (both oral and written).
|- Exclusion criteria||Comorbidity that may influence the non-specific low back pain. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mei-2013|
|- planned closingdate||31-dec-2013|
|- Target number of participants||200|
|- Interventions||Intervention: blended treatment with three face-to-face physiotherapy consults and one to five online consults, using the website My Physio Online (Mijn Fysio Online). The number of consults and total duration of treatment is not fixed in advance, but on average the therapy takes about six to twelve weeks. Online consults consist of online messages from the physiotherapist to the patient and vice versa. The messages from the physiotherapist include exercises and advices. The face-to-face consults consist of explanation of My Physio Online, setting goals for the treatment, evaluating goals, assessing of the performance of the exercises and optional manual treatment, like massages, mobilizations or manipulations.
Control intervention: standard physiotherapy. Number of consults is not fixed in advance, but normally takes about nine consults, during a period of six to twelve weeks. This treatment consist of face-to-face consults, including explanation and advice about low-back pain, setting and evaluation goals for the treatment, giving and assessing exercises and sometimes manual treatment like massages, mobilizations or manipulations. The treatment has to meet the Dutch Low-Back Pain Guideline for physiotherapists (KNGF-richtlijn lage-rugpijn).
|- Primary outcome||Outcome Name: Health status in relation to low back pain.|
1. Roland Morris Disability Questionnaire;
2. Patient Specifieke Klachten (patient-specific functional status in low back pain);
3. Numeric Pain Rating Scale;
4. Short Form 12;
5. Five-Dimensional EuroQol.
|- Secondary outcome||Outcome Name: Patient satisfaction.|
1. Consumer Quality Index;
2. Website Analysis and Measurement Inventory;
3. Self-developed questionnaire.
Outcome Name: Therapist satisfaction.
1. Self-developed questionnaire.
|- Timepoints||Timepoints: 6, 12 and 24 weeks.|
|- Trial web site||www.mijnfysioonline.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. W.J.G. Ros|
|- CONTACT for SCIENTIFIC QUERIES||Dr. W.J.G. Ros|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Physiotherapy with online consults at home could have some advantages over standard physiotherapy. We hypothesize that ‘Mijn Fysio Online’ (a blended version of face-to-face consults and online consults) is as effective in reducing impairments and limitations of patients with low back pain as standard physiotherapy. In this multi-center controlled study we evaluate the effectiveness and patient satisfaction about online physiotherapy compared to standard physiotherapy.
The online physiotherapy consists of 3 face-to-face consults and one to five online consults, using the website www.mijnfysioonline.nl. All participants have to fill in a questionnaire about low back pain, health status, quality of life and satisfaction about the received care. This questionnaire will be e-mailed to the patient at baseline, after 12 weeks and 24 weeks. Also the physiotherapists have to fill in a questionnaire per patient about the given care.|
|- Main changes (audit trail)|
|- RECORD||20-mrt-2013 - 11-apr-2013|