To assess if a continued rehabilitation program in the first six weeks post-surgery for patients following a first time is morecost-effective as compared to no further treatment after discharge from the hospital an economic evaluation alongsideā¦
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are: global perceived recovery (7-point scale), functional
status (Oswestry Disability Index (ODI)), and pain
intensity (leg and back) (11-point NRS).
Qualitative study: factors related to treatment adherence.
Secondary outcome
Also general health (SF-36) return to work and quality of life (EuroQol) are
measured. Costs will be recorded in cost diaries. Timing of measurement:
baseline (in addition to outcomes at baseline also demographics and most
important prognostic factors are measured), 3, 6 and 26 weeks.
Background summary
In The Netherlands there are two strategies for rehabilitation of patients
following lumbar disc surgery. In some hospitals rehabilitation is restricted
to the hospital phase and after discharge there is no more supervised
rehabilitation. If complaints persist at the 6 weeks consultation of the
neurosurgeon, a patient is referred for physiotherapy (PT). However, there are
also hospitals that continue rehabilitation directly after discharge, during
the first 6 weeks after surgery. This rehabilitation is mainly delivered by PTs
in a primary care setting. Since January 1st, 2006, patients can also directly
access PT without a referral (DTF). Then the PT has to decide after initial
assessment if rehabilitation is indicated and some PTs opt for continuation of
the rehabilitation while others don*t. So, regardless of the specific procedure
(referral by neurosurgeon or DTF) there is wide variation in care. Evidence
shows that continuation of rehabilitation within the first 6 weeks is effective
and leads to faster recovery but a head-to-head comparison of the
cost-effectiveness is lacking.
Adherence to the exercise program and advice is expected to influence the
effectiveness of the provided exercise therapy. Adherence to this treatment can
be defined as the extent to which a patient follows recommendations from the
healthcare professional who provides the exercise therapy. However, exercising
happens to be the most common behaviour patients with pain fail to adhere to.
Also adherence to physical activity or following advice is problematic. It is
unclear which factors play a role in adherence to home exercises and advice in
people who underwent surgery for lumbar disc herniation.
Study objective
To assess if a continued rehabilitation program in the first six weeks
post-surgery for patients following a first time is more
cost-effective as compared to no further treatment after discharge from the
hospital an economic evaluation alongside a
randomized controlled trial will be conducted.
The research question of the qualitative study is: what are the experiences of
patients, who underwent lumbar disc surgery, with performing home exercises and
following advice, and which factors play a role in adherence to these home
exercises and advice? Insight into these factors is important, because it can
contribute to the development of strategies that enhance adherence to home
exercises and thus it can increase the quality of care for patients who
underwent lumbar disc surgery.
Study design
An economic evaluation alongside a randomized controlled trial will be
conducted.
The qualitative study uses a phenomenological framework. Semi-structured
interviews will be used to investigate experiences of patients with aspects of
post-operative exercise therapy.
Intervention
Patients are randomised into 2 groups:
1) In the continued rehabilitation group patients will receive treatment
according to standardised treatment protocol.
2) Patients in the control group receive no further treatment after hospital
discharge.
In both treatment groups, according to usual care, the neurosurgeon will decide
together with the patient at the 6 weeks consultation if a patient is referred
for physiotherapy (PT).
Study burden and risks
In the Netherlands there are currently two ways of rehabilitation after lumbar
disc surgery: referral or no referral to a physiotherapist after discharge from
hospital. In our study we do not deviate from the daily practice. In both
treatment groups patients, after about 6 weeks, will visit the neurosurgeon
for a consultation. If the patient has serious complaints a referral for
physiotherapy is indicated, which in this study is also allowed. In short, we
do not deviate from the usual care. Therefore there is no risk to participants
for taking part in this study.
The only extra burden for patients is that they have to complete some
questionnaires. This outweighs by far the undesirable variation in care at this
moment. In the current situation decision making regarding the continuation of
rehabilitation following lumbar disc surgery is mainly opinion-driven and not
evidence-based. This project will provide an answer to the question whether
rehabilitation should be started directly after discharge from the hospital or
not, and will guide evidence-based decision making for patients who undergo
lumbar disc surgery.
The participants in the qualitative study are only interviewed once, without
being asked burdensome questions. This outweighs the current situation of
possibly limited effects of post-surgery interventions due to low adherence and
insufficient insight into factors related to low adherence.
van der Boechorststraat 7
Amsterdam 1081 BT
NL
van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Inclusion Criteria are: patients who underwent a first time, singe level lumbar discectomy and aged between 18-69 years. ;Inclusion criteria for the qualitative part: having received the intervenion in the randomised trial.
Exclusion criteria
Co-morbidities of the lumbar spine (eg. fractures, carcinoma*s osteoporosis, etc) Also patients with cauda equina syndrome will be excluded. Furthermore patients that are pregnant and patients with general contra-indications for exercise therapy will 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 |
---|---|
CCMO | NL35897.029.11 |