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van CCT (UK)

van CCT (UK)


- candidate number25297
- NTR NumberNTR6122
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2016
- Secondary IDsVCWE-2015-087 
- Public TitleBack2Action
- Scientific TitleBack2Action: Psychologically enriched physiotherapy of patients at risk of developing persistent low back pain and/or neck pain.
- ACRONYMBack2Action
- hypothesisAdding an eHealth psychological intervention to physiotherapy in patients with low back pain and/or neck pain with psychosocial risk factors to develop persistent pain is (cost-) effective in reducing disability, psychological complaints (like distress, fear of movement, depression and anxiety), catastrophizing and pain and improving quality of life, coping and self-efficacy.
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP), Depressive symptoms
- Inclusion criteriaParticipants 18 years or older, with non-specific low back pain and/or neck pain for at least six weeks with psychosocial risk factors to develop persistent pain, and proficient in Dutch
- Exclusion criteria1. Serious neck or lower back pathology, e.g. cancer or infection
2. Neck – or back fracture or cervical radiculopathy
3. Systematic diseases, e.g. rheumatoid arthritis
4. Treated by a physiotherapist two months prior to inclusion
5. Currently treated by a mental health professional
6. Treated by a mental health professional two months prior to inclusion
7. patients with severe depressive- or anxiety symtpoms will be excluded
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2017
- planned closingdate1-feb-2020
- Target number of participants260
- InterventionsExperimental intervention: eHealth in addition to physiotherapy (see Care as Usual). The eHealth psychological intervention will consist of a maximum of six online modules and is targeted on; fear of movement, coping, pain catastrophizing, somatization, depression, anxiety and self-efficacy. Patients will be advised to do one or two online lessons per week. Control intervention: Care-as-Usual. Physiotherapy conducted according to the Dutch Clinical Practice Guidelines (KNGF) ‘Physiotherapy for patients with neck pain’ or ‘Physiotherapy for patients with low back pain’. There will be a maximum of 9 multimodal physiotherapy sessions over a 6-week period (manual therapy, exercises).
- Primary outcomeDisability (Neck Disability Index or Oswestrey Low Back Pain Disability Questionnaire) and Perceived Recovery (Global perceived effect, a one-item 7-point Likert scale ranging from ‘worse than ever’ to ‘completely recovered’).
- Secondary outcomePain intensity, Depressive symptoms, Anxiety symptoms, Fear of movement, Pain catastrophizing, Quality of life, Self-efficacy
- TimepointsBaseline, mid-treatment (4 weeks), post-treatment (8 weeks), short-term follow-up (12 weeks), intermediate follow-up (26 weeks) and long-term follow-up (52 weeks)
- Trial web
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESdr. Wendy Scholten-Peeters
- Sponsor/Initiator VU University medical Centre, Faculty of Human Movement Sciences
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsNot applicable
- Brief summaryBeing the first- and fourth greatest contributor to disability, lower back pain and neck pain respectively have a large societal and personal impact. Psychosocial factors, such as anxiety and depression, predict poor recovery and the development of persistent pain in patients with low back pain and neck pain better than physical or biological factors. Although these patients are typically treated with physiotherapy, physiotherapists indicate that they do not feel competent to appropriately identify and treat these psychosocial risk factors, nor do they have the appropriate tools, and focus mainly on the biological aspects of the disorder. There is evidence available that psychological interventions for low back pain are effective. However, there is currently no research available that specifically investigates the management of this population (patients with low back pain and/or neck pain, and psychosocial risk factors) in primary care practices with a multidimensional approach in the form of an added eHealth intervention. The overall aim of this project is to contribute to the optimization of treatment outcomes for patients at risk of developing persistent pain. In this study, we will conduct a randomized clinical trial to determine the (cost)effectiveness of physiotherapy plus an eHealth psychological intervention targeted at psychosocial risk factors versus physiotherapy only, for patients at risk of developing persistent low back – and/or neck pain.
- Main changes (audit trail)
- RECORD15-sep-2016 - 6-jul-2018

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