To study the effectiveness of physiotherapy plus an eHealth psychological intervention targeted at psychosocial risk factors compared to usual physiotherapy care on disability, for patients at risk of developing persistent low back pain and neck…
ID
Source
Brief title
Condition
- Muscle disorders
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability (measured by the Neck Disability Index for neck pain patients or the
Oswestrey Low Back Pain Disability Questionnaire for low back pain patients)
and Perceived Recovery measured with the Global Perceived Effect scale.
Secondary outcome
Pain intensity,
Depressive symptoms
Anxiety symptoms
Fear of movement
Pain catastrophizing
Self-efficacy
Background summary
Being the first- and fourth greatest contributor to disability, both low back
pain and neck pain have a large societal and personal impact. Psychosocial
factors, such as anxiety and depression, are stronger predictors for poor
recovery and the development of persistent pain in patients with low back pain
and neck pain than physical or biological factors. Patients should be
approached according to the biopsychosocial model targeting both biological and
psychological factors. However, physiotherapists indicate that they feel not
competent and equipped to appropriately identify and treat these psychosocial
factors adequately, and focus mainly on the biological aspects of the disorder.
To assist physiotherapists in treating these psychosocial factors, a new
eHealth intervention is developed. This eHealth intervention will be added to
usual physiotherapy care.
Study objective
To study the effectiveness of physiotherapy plus an eHealth psychological
intervention targeted at psychosocial risk factors compared to usual
physiotherapy care on disability, for patients at risk of developing persistent
low back pain and neck pain.
Study design
A single blind multi-center randomized clinical trial with two arms will be
conducted. This study is designed in accordance with the CONSORT statement.
Intervention
Intervention group: e-Health in addition to physiotherapy. The eHealth
psychological intervention will consist of maximum 6 online modules and is
targeted on psychosocial factors, namely; depression, anxiety, fear of
movement, pain coping, pain catastrophizing and self-efficacy. Patients will be
advised to perform one or two online modules per week. The e-Health
intervention will be guided by trained physiotherapists supervised by a
psychologist. Control group (usual care): Physiotherapy conducted according to
the Dutch Clinical Practice Guidelines for low back pain or neck pain (in
Dutch: KNGF). There will be a maximum of 9 multimodal physiotherapy sessions
over a 6-week period
Study burden and risks
The main burden of participating in this trial will be adhering to the program,
i.e. completing the physiotherapy sessions, the eHealth intervention and its
assignments, and online questionnaires. There are no known risks associated
with the investigational intervention.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
1. Consulting a PT with low back pain- or neck pain complaints for at least 6
weeks
2. >18 years of age,
3. Satisfactory proficiency in Dutch
4. Access to a computer and the internet
5. Providing informed consent
6. A minimum of subclinical complaints of two psychosocial factors in the
following domains: depression, anxiety, fear of movement
Exclusion criteria
1. Serious neck or lower back pathology (cancer, infection, trauma)
2. Lumbar or cervical radiculopathy
3. Systematic diseases (rheuma, 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 complaints (PHQ-9>20) or severe anxiety
complaints (GAD-7>15).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59545.029.16 |