No registrations found.
ID
Source
Brief title
Health condition
nonspecifick neck pain, nonspecific low back pain, depressive symptoms, anxiety symptoms, kinesiophobia, pain catastrophizing
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability (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 outcome
Pain intensity, Depressive symptoms, Anxiety symptoms, Fear of movement, Pain catastrophizing, Quality of life, Self-efficacy
Background summary
Being 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.
Study objective
Adding 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.
Study design
Baseline, post-treatment (8 weeks), intermediate follow-up (26 weeks) and long-term follow-up (52 weeks)
Intervention
Experimental 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).
Lisette Bijker
van der Boechorststraat 1
Amsterdam 1081 BT
The Netherlands
+31 205985957
back2action.fgb@vu.nl
Lisette Bijker
van der Boechorststraat 1
Amsterdam 1081 BT
The Netherlands
+31 205985957
back2action.fgb@vu.nl
Inclusion criteria
Participants 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 criteria
1. 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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL5941 |
NTR-old | NTR6122 |
Other | METC VUmc : 2017.286 |