(Cost)effectiveness of a personalized multimodal physical therapy program compared to surgery in patients with cervical radiculopathy: a randomized non-inferiority trial

A neck hernia is a highly painful condition that can lead to significant
limitations in functioning and work. Surgery is the standard treatment when
pain and loss of feeling or strength in the arm persist. However, such surgery
also carries risks of complications and comes with high costs. An intensive
physiotherapy program tailored to the signs and symptoms of each individual
patient appears to have comparable effects as surgery after a year. If this is
the case, it provides patients with a good alternative treatment option and may
help prevent surgeries. We expect that personalized physiotherapy is equally
effective and more cost-effective than surgery. This is beneficial for patients
and society, as patients deserve safe and effective care. Multiple hospitals
are participating in the study. Patients are randomly assigned to either
surgery or physiotherapy treatment, and the effects are measured at 3, 6, 12,
24 and 60 months.

To investigate if a personalized multimodal physical therapy program compared
to ACDF surgical treatment is non-inferior over a 12-month period and
cost-effective in patients with painful cervical radiculopathy who have an
indication for surgery

Hypothesis: A personalized multimodal physical therapy program is less
expensive and non-inferior in effectiveness compared to surgery.

A multicenter (11 clinics), randomized non-inferiority trial, with economic and
process evaluation.

Intervention: A personalized multimodal physical therapy program consisting of
neuromobilizations, cervical mobilizations, exercise, pain education,
behavioral therapy depending on the clinical findings. The number of sessions
is 12 to 18 over a period of ~12 weeks. Only physical therapists who hold a
master's degree and have completed the training are allowed to participate in
the study. They are required to execute the intervention properly and consult
the researchers in case of any issues. Additionally, the researchers maintain
regular communication to monitor progress and assist in resolving any problems
encountered by the physical therapist.

Control (Usual care): Surgery (Anterior Cervical Discectomy with Fusion) with
usual post-operative care.

In order to reduce the burden of physical examination, blood withdrawal and
questionnaire completion, we have carefully selected physical tests and
questions, limiting their number as much as possible while still allowing for
effective research (Table 1). Venous blood samples will be taken to asses
immune parameters. The maximum amount of venous blood taken during the study is
14 ml (7 ml each).

The questionnaires will be administered at baseline and at 3-6-12-24-60 month
follow-up. The physical tests will only be conducted at baseline and at 12
month follow-up (except for the QST Measurements) (Tabel 1, C1 protocol), and
blood samples will be collected at baseline and 6 months follow-up.


The patients assigned to the personalized multimodal physical therapy will be
treated by a specialized physical therapist near their residential area. The
researchers will train and invite participating physical therapists to join the
study. Patients assigned to the personalized multimodal physical therapy will
receive 12-18 sessions of half an hour each. Patients assigned to the surgery
will receive usual care.

Participation in this study may be of benefit to patients as both interventions
reduce pain intensity and improve quality of life. Recent studies show that
multimodal physical therapy treatments are effective in reducing pain
intensity, neck mobility, daily functioning and quality of life. Additionally,
a systematic review shows that manual therapy leads to clinical improvements in
neck pain and disability at the short term. Exercise therapy is also considered
an effective treatment strategy for cervical radiculopathy. Surgery is an
effective treatment for pain relief and improvement in daily functioning.
Although surgical treatment provides a faster pain reduction compared to
conservative care, the effectiveness at the long term is comparable. The
overall complication rate for ACDF ranges from 13.2% to 19.3%. These include in
descending order; dysphagia (1.7%-9.5%), postoperative hematoma (0.4%-5.6%
(surgery required in 2.4% of 5.6%), with epidural hematoma 0.9%), symptomatic
recurrent laryngeal nerve palsy (0.9%-3.1%), cerebrospinal fluid leak
(0.5%-1.7%), wound infection (0.1-0.9%-1.6%), increased radiculopathy (1.3%),
Horner*s syndrome (0.06%-1.1%), respiratory insufficiency (1.1%), esophageal
perforation (0.3%-0.9%, with a mortality rate of 0.1%), and instrument failure
(0.1%-0.9%). No serious adverse effects are reported for multimodal physical
therapy rehabilitation. The addition of QST measurements (Pressure, heat and
cold tests) was discussed with our patient panel. They acknowledged that the
development of a prediction model provides valuable benefits for personalizing
care. It was also noted that incorporating QST does not exceed the time limits
of a comprehensive physiotherapeutic consultation for the patient.

Under the basic insurance, physical therapy treatment is reimbursed for CR with
motor deficits, starting from the 21st treatment, for a maximum of 3 months.
For this project, an Innovation Policy rule will be requested from the NZA
(Nederlandse Zorg Autoriteit), with a preferred health insurance company.