The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients'…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
aspecifieke lagerugpijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be walking and/or cycling according to the
NNGB and social support.
Secondary outcome
Other outcomes will be
1. measures of illness perceptions.
2. measures of comorbidity, BMI, number of recurrences of non-specific low back
pain, measures of attitude and intention to physical activity
3. measures of refusal of the study.
Background summary
The global burden of low back pain is enormous. Results of the latest Global
Burden of Disease, Injuries and Risk Factors study confirms low back pain as
the greatest contributor to disability worldwide with a lifetime prevalence of
39.9% (SD±24.3%) and estimates of recurrence at 1 year range from 24% to 80%
(Hoy et al., 2010, Hoy et al., 2012, Buchbinder et al., 2013, Manchikanti et
al., 2014). Causes of low back pain are mostly unknown, in 90% pain is not
attributed to a recognisable pathology, which is defined as non-specific low
back pain (Staal et al., 2013). Factors associated with the recurrence of
non-specific low back pain are age, low levels of physical activity, smoking,
overall poor health, comorbidity, obesity and not having a paid job (Hestbaek
et al., 2003, Shiri et al., 2010, Nilsen et al., 2011, van Oostrom et al.,
2012, Hartvigsen et al., 2013, Shiri et al., 2013). In most circumstances, it
seems that non-specific low back pain, particularly with a persistent course,
cannot be successfully treated with individual interventions of any kind
(Friedly et al., 2010).
The recurrence rate and the number of recurrences of non-specific low back pain
could be reduced and time to a next episode could be prolonged by advising an
active lifestyle (Staal et al., 2013). Additionally there is a positive effect
of active lifestyle including physical activities on outcomes of pain and
disability (Ooijendijk et al., 2007, Wai et al., 2008, Smith et al., 2010, Choi
et al., 2010, van Middelkoop et al., 2010, Dahm et al., 2010, van Middelkoop et
al., 2011, Hendrick et al., 2011, Staal et al., 2013).
This proposal addresses physical therapy in the management of non-specific low
back pain in the clinical setting in which an additional advice to assume
regular physical activity is given.
Advising regular physical activity to patients suffering from non-specific low
back pain includes an appeal to patients to adhere to this advice. Many
non-specific back pain sufferers do not seem to adhere to physiotherapist's
advice (Kolt et al., 2003, Beinart et al., 2013). In our previous study only 8%
of non-specific low back pain sufferers adhered to an activity advice and
self-report was inaccurate (Zandwijk et al., 2015, van Koppen et al., 2016).
There is strong evidence that poor treatment adherence in patients typically
managed in musculoskeletal physiotherapy outpatient settings is associated with
low levels of physical activity at baseline or in previous weeks, low
in-treatment adherence with exercise, low self-efficacy, perceived illness
beliefs, depression, anxiety, helplessness, poor social support for activity,
greater perceived number of barriers to exercise and increased pain levels
during exercise (Medina-Mirapeix et al., 2009, Medina-Mirapeix et al., 2009,
Jack et al., 2010,). Influencing these factors may improve adherence behaviour
(Goulding et al., 2010, Olander et al., 2013).
After executing an Intervention Mapping procedure, two important
interventions to positively change adherence behaviour to an activity advice
remained and consisted of *treatment of illness perceptions* and *organizing
social support* (Appendix 1). Leventhal's self-regulation model shows that
maladaptive Illness perceptions predict maladaptive health behaviour and
activity limitations in a variety of illnesses and conditions, including low
back pain. These illness perceptions are recognised as target for treatment and
can be positively influenced (Siemonsma et al., 2013).
In this study influence of patients* illness perceptions and social support on
adherence behaviour to an activity advice will be investigated.
Study objective
The primary objective of this study is to investigate whether social support by
a partner or friend and treatment of patients' illness perceptions influences
the rate of adherence to an activity advice compared to treatment of patients'
illness perceptions alone in patients suffering non-specific low back pain.
Secondary objectives are;
1) Whether *treatment of illness perceptions* changes patients* maladaptive
illness perceptions into realistic ones,
2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or
rate of recurrences of non-specific low back pain and/or attitude and intention
to physical activity influences patient*s adherence to an activity advice.
Study design
This study is a multicentre randomized two arm, controlled clinical trial.
During a twelve-week intervention period, one group of patients will receive an
activity advice added to usual treatment including *treatment of illness
perceptions* (C-group). The other group will receive an activity advice and the
intervention addressing social support by a partner or friend added to usual
treatment including *treatment of illness perceptions* (SoSup-group). Patients
will be assessed at baseline, and after one, 6 and 12 weeks. Recruitment is
scheduled from October 2016 to July 2017. The study will be performed in 12
centres for physiotherapy in the province Zuid-Holland, the Netherlands.
Intervention
In both the C- and SoSup-group an activity advice will be added to usual
treatment. The advised activities will be walking and/or cycling outdoors,
meeting the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et
al., 2007). In both groups cognitive treatment on illness perceptions according
to the common sense model to the patient in the presence of the partner or
friend will be given. During a maximum of two half-hour contacts in a
standardised dialogue on maladaptive beliefs and feelings about identity,
time-line, causes, controllability, and curability of low back pain are mapped,
maladaptive perceptions are challenged, alternative perceptions are formulated
(Siemonsma et al., 2013).
The intervention in the SoSup-group (intervention group), organizing social
support by a partner or friend depending on patient*s preferences, will be
added. During a maximum of two half-hour contacts (one for explanation and one
for evaluation), in a standardised discussion the partner or friend will be
stimulated to support the patient in executing the activity advice.
During 12 weeks the social support by a partner or friend will be executed for
at least 5 times a week.
Study burden and risks
The social support described in this study is designed for better outcomes of
physical activity levels patients suffering low back pain, and has no proven
advantage on better outcomes on pain and disability in non-specific low back
pain sufferers. Therefore we consider there is no disadvantage in the
SoSup-group versus the C-group because patients in both groups receive
concomitant best evidence healthcare according to the Dutch guideline for low
back pain (Staal et al., 2013).
No adverse effects of the interventions are expected. There are no ethical
implications to be expected as a result of this study, treatment of all
patients during the intervention period will be according to the Dutch
guideline for low back pain.
Ooltgensplaathof 20
Rotterdam 3086ND
NL
Ooltgensplaathof 20
Rotterdam 3086ND
NL
Listed location countries
Age
Inclusion criteria
patients >=18 years presenting with at least a second episode of non-specific
low back pain are recruited for the study
Exclusion criteria
Patients are excluded when presenting red flags as mentioned in the low back
pain guideline (Henschke et al., 2009, Staal et al., 2013), patients physical
active in accordance with the Dutch standart healthy physical activity (NNGB)
(Hildebrandt et al., 2007) and patients with a medical history of cancer,
osteoporosis, rheumatoid arthritis, tuberculosis, trauma and fractures in the
lumbar spine as well as recent infections in the musculoskeletal system.
Patients unable to read, write or speak the Dutch language will also be
excluded
Design
Recruitment
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 |
---|---|
ClinicalTrials.gov | NCT02996955 |
CCMO | NL58005.096.16 |