Condition category
Musculoskeletal Diseases
Date applied
10/07/2014
Date assigned
10/07/2014
Last edited
26/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lumbar fusion surgery is a large and complex operation that involves placing screws and rods into the lower back. This is done to help people who are affected from lower back pain and sciatica (nerve pain that runs down one or both legs). In many cases the surgery does not relieve all the pain and people can still have pain and disability for years after the operation. Research has shown that offering people rehabilitation after some types of spinal surgery can be helpful in addressing these problems. This study is designed to see if it is possible to provide people with quite complex rehabilitation after surgery. It will also see whether this approach helps their recovery.

Who can participate?
Patients aged 18 to 75 years who are waiting to receive lumbar fusion surgery in the participating hospital can take part.

What does the study involve?
The study will involve asking people who have decided to have this operation if they would like to consider joining our study. If they agree to join the study we will randomly decide which group they should go into. This decision is made randomly, which means that no member of the research team, the surgeon or the person themselves can choose which treatment they receive after their operation. This is similar to tossing a coin. The study will have two groups of people in it. One group, called usual care, will have all the usual surgical aftercare that people receive after this operation. This includes advice and physiotherapy. The other group, called the rehabilitation group, will be asked to come along to our rehabilitation group after surgery. This takes place once per week for 10 weeks and each session lasts about 90 minutes. Each session involves advice, exercises and sharing experiences with other people who have had a lumbar fusion. Both groups will not begin until the surgeon has reviewed the people at 3 months after the operation to ensure that they are fit and well enough to participate. All the people will have their operation as planned and being part of the study will not affect this at all. Everyone will have all the normal care that people get after this operation. This involves treatment in the hospital to ensure they are well enough to go home. Once they are fit to go home they will be given advice on how to slowly progress their activity levels. Everyone will also have check-up with their surgeon 6 and 12 weeks after the operation. If the surgeon is happy that everything is satisfactory at 12 weeks after the operation the participants will be able to begin rehabilitation (either as usual care or as part of the rehabilitation group). At 6 months after the operation they will again be seen by their surgeon to have another check-up. The person in charge of the study will ask everyone in the study to fill out some questionnaires and perform a short physical test. This is done to see how they are progressing.

What are the possible benefits and risks of participating?
It is possible that attending the rehabilitation group will be helpful to people. We have run a smaller study previously and people generally improved with rehabilitation. However, it is by no means sure that by attending the rehabilitation group people will gain any benefit. It is very unlikely that there will be any problems related to attending the rehabilitation group. Exercise after fusion surgery is generally accepted to be safe as long as it is not begun too early and the surgeon is happy with the progress of the operation.

Where is the study run from?
The National Hospital for Neurology and Neurosurgery, which is part of UCLH NHS Foundation Trust, UK

When is the study starting and how long is it expected to run for?
June 2014 to December 2016

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Mr James Greenwood
james.greenwood@uclh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr James Greenwood

ORCID ID

Contact details

Centre for Medical Imaging
235 Euston Road
London
NW1 2BU
United Kingdom
-
james.greenwood@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16761

Study information

Scientific title

Evaluating a rehabilitation protocol following lumbar fusion surgery (REFS): a feasibility study

Acronym

Study hypothesis

Approximately 40% of patients following lumbar fusion surgery would rate themselves as clinically unchanged or worse at 2 years post surgery. The outcomes of some forms of spinal surgery can be improved with rehabilitation. We aim to see if it is possible to provide small groups of complex rehabilitation to patients 3 months after they have undergone a technically successful lumbar fusion. This will evaluate recruitment and compliance as well as secondary measures of clinical outcome.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16761

Ethics approval

14/LO/0748; First MREC approval date 13/06/2014

Study design

Randomised; Interventional and Observational; Design type: Process of Care, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

Patients (aged 18-75, listed for elective lumbar fusion for degenerative disease) will be selected from the neurosurgical waiting list. Those that express an interest in the study will be given the patient information sheet. They will then discuss the study with the CI at a pre-operative assessment. Those that agree to enroll will be asked to provide consent and baseline data preoperatively. Participants will then be randomised to either the rehabilitation group or usual care. Randomisation will be via block randomisation using codes generated at a remote site. These will be concealed by the use of sealed, numbered, opaque envelopes. We aim to recruit 50 participants over 30 months.

All participants will receive identical post-operative management during their hospital stay and for the first 12 weeks. This involves a relative reduction in activity; they are not allowed to lift anything heavier than a kettle and are advised to steadily increase their outdoor mobility within the bounds of pain up to a maximum of 2 miles. All participants will have a review with the surgical team at 6 and 12 weeks post-operatively in accordance with normal clinical practice. Following a satisfactory 12-week post-operative surgical review (absence of technical failure of the construct, e.g. infection, loosening) participants will begin their allocated post-operative care (usual care or rehabilitation).

1. Usual care consists of a single advice session to progressively increase physical activity within the bounds of pain. Further treatment such as referral to a physiotherapist will be at the discretion of the surgical team or general practitioner. Participation in the study will not preclude any post-operative treatment that is deemed necessary.

2. Those participants randomised to the rehabilitation group will be invited to attend. The group runs once per week for 10 consecutive weeks, and each session lasts a maximum of 90 minutes. Each session consists of a brief educational session utilising principles of CBT, individualised, supervised, progressive exercises and concludes with a peer support session.

Data collection occurs at baseline (pre-operatively) 3, 6 and 12 months post-operatively. Surgical follow-up occurs at 6 weeks, 3, 6, 12 and 24 months post-operatively.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility; Timepoint(s): Assessment of willingness to participate, compliance etc

Secondary outcome measures

Oswestry disability index (ODI)

Overall trial start date

01/06/2014

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

50 subjects will be recruited between the ages of 18-75 years of age, with or without radicular leg pain who have been placed on the waiting list for elective lumbar fusion surgery at the NHS host

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50; Description: The group of total participants n=50 will be randomly split into two equal groups

Participant exclusion criteria

1. Spinal cord involvement
2. Post-operative complications
3. Revision fusion surgery (previous history of decompressive surgery will be eligible)
4. Lower limb joint pain which interferes with assessment or ability to exercise
5. Can walk less than 20 m
6. Severe, poorly controlled psychological or physical co-morbidity
7. Inadequate verbal and written English
8. Unable or unwilling to undertake exercise, attend post-operative programme or to give signed consent

Recruitment start date

01/06/2014

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Medical Imaging
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Clinical Doctoral Research Fellowship (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26040543

Publication citations

Additional files

Editorial Notes

26/02/2016: Publication reference added.