Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04968444 |
| Other study ID # |
247300 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
May 2021 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
Faye Shorthouse |
| Phone |
02071885082 |
| Email |
faye.shorthouse[@]gstt.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research is aiming to address whether a group workshop is a more superior treatment to
traditional physiotherapy for the management of back pain in a hospital workforce. In the UK
during 2016-17, 31.2 million work days were lost due to work-related ill health and injury.
Of these 8.9 million were down to musculoskeletal disorders. This equated to 17.6 days per
person. In the general population, the reports of low back pain have been as high as 36% of
adults with a first occurrence. In an adult's lifetime, the prevalence of chronic low back
pain is about 23%. This makes the importance of managing these conditions of great
importance. And the impact to a working population is great, in respects to work
satisfaction, sickness and absenteeism. Significance should also be placed on the impact this
has to the individual, with regards to their health and wellbeing.
The participants will be taken from NHS staff working within the hospital environment and
that self-refer internally for physiotherapy into the Trust's Occupational Health Service.
Once the participants are accepted in Occupational Health Physiotherapy, they are managed as
staff requiring physiotherapy and not at 'patients'. There is no contact with their primary
care practitioner. For the study, participants will either receive traditional one to one
physiotherapy or a bespoke one off workshop. All of the participants will be followed up 3
months after their treatment has finished.
Description:
Traditionally, treatment for chronic pain, and back pain in particular has been on exercise
and education. Back schools and multi-speciality classes are evidence based effective
management recommended to this population (Heymans et al, 2004; Airaksinen et al, 2006).
However, for a busy NHS Trust, staff taking time out of their week for 6-12 weeks would not
be practical or supportive to patient care and work-life balance. Therefore a one-off seminar
based lecture and interactive workshop would be using less clinical time for the staff to
attend and may be better for both the individual and the organisation.
The importance of piloting a novel method of delivering treatment to this cohort is to ensure
that the content is supported by the current evidence. A Cochrane review (Cochrane 2004)
found moderate evidence that Back Schools in an occupational setting can reduce pain and
increase functional and return to work status in the short and intermediate term. Waddal's
review (2001) also supports this idea, stating the some form of back school or MDT
(multidisciplinary team) rehabilitation at the sub-acute stage has produced faster recovery.
The Kamper study (2015) concluded that MDT delivery of care was better than physical
treatment in the occupational setting for back pain management. There is therefore no clear
affirmative support for a specific method of care delivery but having a group environment of
similar pathology and using an MDT skill mix is recommended.
The Occupational Health Model of care within this setting is aiming to deliver bespoke
information to specific cohorts of staff and pathologies with the long term aim of
self-management and injury prevention. Waddel et al (2004) has suggested innovative education
approaches for prevention and management, specifically designed to overcome psycho-social
issues and encourage responsibility for their own care. Therefore a successful intervention
should encapsulate these ideas.
As there is little research into the novel approach of delivering seminar-style MDT education
and advice to a cohort of staff, this pilot will assess the effect of this intervention.
The purpose of this research is to compare the effectiveness of 2 interventions for the
management of chronic spinal pain in staff members based in a hospital setting. The primary
aim is to establish the most effective method of management for this sub group of staff. This
research came from service user feedback and management issues around staff having to take
considerable amount of time away from clinical activity. And the trend noticed in the Trust
for increasing back pain referrals. Therefore, the investigators were looking at a way that
could make an intervention effective and have minimal impact on staff being away from their
work duties. However, the results of this study will inform practice for the best management
for back pain across all working populations and therefore can be generalizable outside of
this selected target group.
For recruitment to the study, The Occupational Health Physiotherapy service is routinely
advertised on the Trust intranet webpage (internal staff site) and at roadshows and Trust
induction. The research team would not be advertising our study but making staff aware when
the referral is received that the team are running and trial and that they have been
allocated to attend one of the two group.
When the staff member is contacted by phone and booked into their session, the participant
will be emailed confirmation of the appointment details and the participant information
sheet. Each participant will be advised that they can change their mind about treatment
allocation up to the day of appointment and tehe investigator would be gaining signed consent
at this time so they have up to 2 weeks to decide. Witnessed consent will be gained at the
initial meeting either in the workshop or in the initial one to one session. All staff at
GSTFT speak English and therefore should be able to independently read and sign any
information and forms.
The inclusion/exclusion criteria are as follows:
Inclusion criteria:
1. Staff member of GSTFT
2. New referral with a history of spinal pain (cervical/ thoracic/ lumbar) for more than 3
months
3. Consents to attend 2 sessions - seminar and follow up if in BOOST workshop, or complies
with one to one treatment as outlined by the treating therapist.
Exclusion criteria:
1. Acute spinal pain - that of 6 weeks or less
2. Had treatment for the condition of chronic spinal pain in last 6 months as may still be
gaining treatment benefits from this and unclear if change was due to our interventions
This project has been discussed at Occupational Health roadshows run in the Trust and staff
have been asked for feedback on the plans for the project. All are in favour of a
multi-disciplinary approach and the contact with staff is favourable. There was concern about
the meaning of 'traditional physiotherapy'. This was explained that all those in this group
would have a tailored treatment programme dependent on assessment. Staff were also concerned
about being allowed to attend appointments and the possibility that they may have to miss
some. The investigators explained that there is no requirement for compliance due to the
nature of the intervention - the BOOST workshop is a one-off intervention and the 1-1
treatment group is routine physiotherapy care. All non-attendance will be noted and reported
in the project analysis.
The data to be collected will be as follows:
Pre-intervention - all at baseline
- Patient demographics - age, sex, work-type classification (from patient referral form)
- Sickness absence (in last 3 months) (from initial data collection questionnaire)
- Numerical rating scale for pain (NRS) (from initial data collection questionnaire)
- Patient specific functional scale (PSFS) (from initial data collection questionnaire)
- Patient-activation measure (from initial data collection questionnaire)
- StarT Back (screening tool for sub-group analysis). (from initial data collection
questionnaire)
Post-intervention
- Sickness absence (in last 3 months) (from final contact/follow up data collection
questionnaire)
- Numerical rating scale for pain (from final contact/follow up data collection
questionnaire)
- Patient specific functional scale (from final contact/follow up data collection
questionnaire)
- Service evaluation questionnaire (from final contact/follow up data collection
questionnaire)
- Patient-activation measure (from final contact/follow up data collection questionnaire)
The treating/intervention therapist will issue the questionnaire/data collection sheet for
the participant to complete. This is then handed to the administrative staff for entry on the
central database to support reducing risk of bias.
Sickness absence, NRS and PSFS are all validated outcomes to show change over time and
occupational improvement following an intervention. StarT Back is a stratification tool only
taken at initial contact to sub-group the participant in relation to their back pain. This is
for us to analyse the most likely group to respond to each intervention as a possible
variable to outcome.
