FORVAD
Research type
Research Study
Full title
Clinical and Cost-effectiveness of Posterior Cervical Foraminotomy versus Anterior Cervical Discectomy in the Treatment of Cervical Brachialgia: A Multicentre, Phase III, Randomised Controlled Trial (FORVAD Trial)
IRAS ID
249138
Contact name
Simon Thomson
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
Research Summary
FORVAD is a Phase III, randomised trial in patients with unilateral cervical brachialgia (arm pain affecting just one limb) that has been caused by neve compression in the neck. The trial population are those who have had symptoms for at least six weeks despite conservative management such as physiotherapy and pain relief. A total of 252 participants will be recruited, and randomised to receive one of two types of operation. One type of operation is posterior cervical foraminotomy (PCF), which involves operating through the back of the neck. The other type of operation is anterior cervical discectomy (ACD), which involves operating through the front of the neck. Both of these operations are currently standard treatments for this condition. Potential participants will be identified in neurological centres in the UK following referral from their GP, they will be given a Patient Information Sheet and then informed consent will be taken if they would like to take part. Participants will then be registered to the study, and have assessments performed. Participants will complete questionnaires, then be randomised to a treatment arm on the day of their operation. The day after surgery, and at 6 weeks post-surgery, assessments will be performed on the participants. On day 1, and weeks 6, 12, 26, 39 and 52 after surgery, participants will complete questionnaires. 25% of participants will also have a voice recording taken to assess if their voice is affected by the operation, before surgery and 6 weeks after surgery.
Summary of Results
Cervical brachialgia is pain that starts in the neck and travels down to the arm. Many patients who have cervical brachialgia make a quick recovery but for some patients with this condition, the pain does not go away, and in 15% of patients, the pain is so bad that they are not able to work.
The posterior cervical Foraminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia (FORVAD) trial compared two types of neck surgery that are both routinely used in the NHS to treat cervical brachialgia: posterior cervical foraminotomy (surgery from the back of the neck) and anterior cervical discectomy (surgery from the front of the neck). The FORVAD trial aimed to find out which of these two operations is better at relieving pain and costs the NHS less money overall. We also looked at how many complications patients had in the first 6 weeks after their operation and how patients’ pain and quality of life changed over the course of the year after their surgery.
The FORVAD trial took place at 11 NHS hospitals across the United Kingdom (UK). We had originally planned to recruit 252 participants to the FORVAD trial from 15 UK hospitals but the trial was stopped early because the recruitment of participants to the trial was much slower than expected. In total, 23 participants took part in FORVAD and were randomly allocated by a computer system to receive either posterior cervical foraminotomy or anterior cervical discectomy; the process of randomly allocating patients to one treatment or another is called randomisation.
The number of participants who took part in the trial was too small to enable us to say which surgery is best for treating cervical brachialgia. To find out why it was difficult to recruit patients to the FORVAD trial, we interviewed hospital staff and trial participants about their experiences of taking part in FORVAD. We found out that hospital staff sometimes found it difficult to organise everything needed to be able to randomise patients to the trial on the day of surgery. Other staff found it difficult to randomise patients to the trial because they already had an opinion about which treatment they thought would be best for the patient.
We would like to thank all the participants and NHS Trusts who took part in the FORVAD trial. Even though we were not able to answer the research question, the data collected in this trial will still be useful in helping to design future research. Finding out which type of surgery is best to treat cervical brachialgia is still very important, and we hope that the data we have collected in the FORVAD trial can help to answer this question in the future.
The FORVAD trial was centrally coordinated by the Clinical Trials Research Unit based at the University of Leeds, on behalf of Leeds Teaching Hospitals NHS Trust, who was the trial sponsor (the organisation who took responsibility for the running of the trial). FORVAD was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (16/31/53).
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0682
Date of REC Opinion
17 Oct 2018
REC opinion
Favourable Opinion