Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03791164 |
| Other study ID # |
176/17 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2019 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
May 2019 |
| Source |
Teesside University |
| Contact |
GILLIAN FINDLEY |
| Phone |
07788903313 |
| Email |
gillian.findley[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This investigation is a mixed methods research proposal to answer the question: 'Does Using
the Pain Toolkit Improve Outcomes for Patients accessing the North of England Regional Back
Pain Pathway?'. The study is part of a 5 year professional doctorate programme at Teesside
University. The aim of the study is to test whether with a double blind randomised controlled
trial patients accessing the North of England Regional Back Pain Pathway experience reduced
Oswestry Disability Index (ODI) when using the pain toolkit compared to a control group of
patients offered the standard treatment. The study also contains a nested qualitative element
which aims to explore the participants' experiences of using the Pain Toolkit.
According to the British Pain Society (2017), chronic pain management is a significant burden
to the National Health Service NHS. Back pain alone accounts for a significant disease burden
and loss in productivity among working people (Al Mazroa 2013 and TUC 2008). Commissioners
must justify their expenditure on health services to the local population and therefore for
an area such as pain management where there is significant disease prevalence (WHO 2013) and
significant costs, potential service developments should be considered. The development of
the pain toolkit (Pain Toolkit 2017a) as a straightforward, easy to use self-management
option offers a potentially cost effective support mechanism for patients but as yet there is
no evidence to support its use in clinical practice. This study aims to fill that knowledge
gap.
Description:
Research Questions The overarching aim of this mixed methods study is to investigate whether
the use of a structured self-management programme (the Pain Toolkit) results in better
outcomes for patients with chronic back pain compared to usual care. There will be a
quantitative and qualitative component to the work. In the quantitative component patients
will complete outcome measure scores at baseline and then 6 and 12 months after receiving the
Pain Toolkit or the standard programme for self-management. In the qualitative component a
group of patients will be invited to participate in semi-structured interviews after using
the Pain Toolkit. The interviews will explore their experience of using of the toolkit, its
acceptability and ease of use.
The principle research question is:
1. To investigate the effectiveness of structured self-management (the Pain Toolkit)
compared to unstructured advice/information on function for patients discharged to
self-management from an evidence based back pain pathway.
The secondary research question is:
2. To investigate the effectiveness of structured self-management (the Pain Toolkit)
compared to unstructured self-management advice/information on pain for patients
discharged to self-management from an evidence based back pain pathway.
3. To investigate the effectiveness of structured self-management (the Pain Toolkit)
compared to unstructured self-management advice/information on quality of life for
patients discharged to self-management from an evidence based back pain pathway
4. To investigate the effectiveness of structured self-management (the Pain Toolkit)
compared to unstructured self-management advice/information on healthcare utilisation
for patients discharged to self-management from an evidence based back pain pathway
5. To explore patients' experiences of using the Pain Toolkit for self-management of pain
Background There is a wealth of literature outlining the disease burden of chronic pain and
in particular back pain, which forms the basis of the background to this study. Pain is
widespread in the UK with almost 10 million people affected almost every day (British Pain
Society 2015). More locally, for Durham Dales, Easington and Sedgefield Clinical
Commissioning Group (DDES CCG) where the student researcher works, the highest cost
prescribed drug is Pregabalin which is primarily used as a pain relieving medication. The CCG
spends in excess of £2m per year on this one drug alone (DDES 2016). Focussing on the
literature relating to back pain, the World Health Organisation state that: 'back pain is not
a disease but a constellation of symptoms. In most cases, the origins remain unknown' (WHO
2013). In 2010 the Global Burden of Disease Study estimated that low back pain was among the
top 10 diseases and injuries that account for the highest number of Disability Adjusted Life
Years worldwide (Al Mazroa 2013). The impact of this is demonstrated in the UK, by the Trades
Union Congress (TUC 2008) who reported that British businesses lose an estimated 4.9 million
days per year to work related back pain, with the North East of England suffering more than
most. Other authors concur that most people will experience low pain at some point in their
lives (Hoy, Brooks et al 2010 p769; Yang et al 2016 p459).
The full cost to the NHS of chronic pain and its management is not known (BPS 2017). For the
specific area of low back pain the World Health Organisation report back pain is one of
'seven high-burden conditions….for which the currently available treatment is inadequate in
reversing or halting the progression of disease '(WHO 2013 page x). The evidence above shows
that back pain is therefore such a widespread concern to patients and commissioners that it
is important to look for an evidence-based approach to manage it.
Using the research question: 'Does using the pain toolkit improve outcomes for patients
accessing the north of England regional back pain pathway?' the student researcher consulted
the following databases and found no results referencing the Pain Toolkit: AMED, EMBASE, OVID
on line, EBM, HMIC and CINAHL. This would indicate that the Pain Toolkit as a method for
self-management of pain has not been well studied. The search terms were widened to include
programmes of self-management of chronic pain. The same databases were searched using the
extended terms. 135 articles were returned from the search which was then narrowed by
removing duplicates and articles that were described as study protocols or descriptive
studies. 2 papers describing randomised control trials or RCTs were removed because they
related to a physical activity programme rather than self-management. One article found
during the literature review reported a review of RCTs which gave advice within
self-management programmes (Liddle, Gracey and Baxter 2007). This paper undertook a
systematic review of 39 randomised control trials exploring various aspects of advice on
self-management for patients with back pain. The authors concluded that 'No conclusions could
be drawn as to the frequency and content of advice that is most effective for LBP [lower back
pain] due to the limited number and poor quality of RCTs in this area' (Liddle, Gracey and
Baxter 2007 p310). They conclude that 'more investigation is needed into the role of
follow-up advice for chronic LBP patients' (Liddle, Gracey and Baxter p 327). They also found
that a wide variety of outcome measures were used in the various studies making meaningful
comparisons between the studies difficult.
As has been argued above, although back pain is a significant burden to patients and the NHS,
the area of self-management has not been well studied and there is no clear guidance as to
appropriate content for self-management programmes. The studies related to self-management
programmes are hampered by use of diverse outcome measures and lack of rigor. Consequently an
appropriately powered randomised control trial, using a validated outcome measure to assess
the effectiveness of a specific intervention, such as the pain toolkit, is required to
address these inadequacies in the literature.
To test the effectiveness of the pain toolkit the following experimental hypothesis has been
developed: Patients using the Pain Toolkit will report an outcome of a 10 point reduction in
the Oswestry Disability Index compared with patients using standard support.
Methods In the proposed study, the intervention of the Pain Toolkit is to be tested to see
whether its use in a specific cohort of patients with back pain at the point of discharge to
self-management, will improve health outcomes. In order to test this there will be 2 groups
of patients who are randomly allocated to receive either the pain toolkit or defined standard
treatment. Other study designs such as case control and cohort studies were considered,
however, because the study is prospective, involves the use of a specific intervention and is
time limited a randomised control trial was judged to be the most appropriate design. For the
qualitative aspect of the study a smaller cohort of 8-12 patients will be selected from the
group that receive the Pain Toolkit to participate in semi-structured interviews, loosely
based around the readiness to change theory (Kerns et al., 1997, Lorig and Stewart 1996).
This aspect of the study will explore participants' experiences of using the Pain Toolkit. A
flowchart showing the process for recruitment is shown at appendix 11. The questions within
the semi-structured interviews are designed to explore whether the participant had tried any
other self-management programmes prior to starting to use the intervention for the study.
This deductive approach had led to a conceptual framework that attitudes towards
self-management may be enhanced by structured literature to support the participant. This
concept will be explore during the qualitative aspect of the study and will give context to
the findings of the quantitative study.
Sample - Quantitative Study The study group will be a convenience sample of patients
accessing the back pain pathway at the point of discharge to self-management. Inclusion
criteria are: patients with back pain who have been referred to the North of England regional
back pain service who consent to take part in the study. Exclusion criteria are patients with
red flag indicators where immediate referral to secondary is indicated (NICE 2016). In
addition children less than 18 years and, people who do not speak English and people with
reduced mental capacity will be excluded. Although easy read versions of the toolkit are
available (Pain toolkit 2017b), the Back Book that will be used for the control group is only
available in English.
Using the NQUERY software, we estimate that a sample size of 70 in each group will have 90%
power to detect a difference in mean change of 10 points (this is considered by NICE to be a
clinically relevant change) between the intervention and comparator groups assuming that the
common standard deviation (SD) of change is 18 points using a two group t-test with a 0.050
two-sided significance level. The estimate of SD of change scores was obtained from some
previously collected data involving 967 participants. Ultimately, the data will be analysed
with a similar between-subjects model for comparison of change scores, but with covariate
adjustment for baseline measurements, age and sex. Similar studies show a 30% drop out rate.
Therefore to ensure that the study is appropriately powered, 100 participants will be
recruited for each group, giving a total of 200 participants overall.
The study will also consider refusals, drop outs and loses to follow up. This may include
patients who do not use the pain toolkit during the study period or who do not complete the
outcomes measures. It would potentially impact on the interpretation of the study results if
either of these groups were large in number, it will therefore be important to determine how
their results will be reported at the end of the study. An anticipated dropout rate of 30%
will be included in the power calculation.
Instruments and analysis are described elsewhere in the registration application.
Conclusion As shown previously the impact of reducing pain in patients will have significant
personal and economic benefits for patients and the whole health economy. The pain toolkit is
perceived as an easy to use, widely available self-management tool that could be given to
patients at any point in their pathway. There is however little evidence to back its use and
so research is needed in this area. Should the study prove that patients using the pain
toolkit experience a reduction in their ODI score this may indicate that it would be cost
effective to offer the pain toolkit more widely to patients. Conversely if the study shows
that there is little or no benefit in the use of the pain toolkit then alternative
self-management tools can be explored.
