Clinical trial NCT02630732: Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy?
Official title: Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? A Randomized Controlled Trial With Two-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: Back School
Brain School
Lumbar surgery
Education
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2015-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary scientific objective of the study entails examining whether perioperative pain neuroscience education (PPNE or 'brain school') is more effective than classical back school in reducing pain and improving pain inhibition in patients undergoing surgery for spinal radiculopathy. A secondary objective implies examining whether PPNE is more effective than classical back school in imparting a behavioural change (i.e. decreasing postoperative healthcare expenditure for lumbar radiculopathy), improving functioning in daily life and improving surgical experience (=better prepared for surgery, surgery meeting their expectations) in patients undergoing surgery for spinal radiculopathy.

Detailed description: Prior to this study on lumbar radiculopathy patients, the proposed CPM protocol with EEG recordings will be pre-tested on a group of twenty healthy subjects, who will be fully informed about the study and subsequently gave their consent to participate. The proof of concept is set up to evaluate the effectiveness of the protocol, more specifically the appearance of nociceptive evoked potentials induced by electrical stimulation and the load on the subjects, as well as the safety of the protocol.

Low back pain is a frequently reported problem in our community. In the absence of successful outcomes following conservative intervention, surgery (including lumbar discectomy) is a recommended, evidence-based treatment for lumbar radiculopathy. To prevent chronicity following spinal surgery, preoperative education seems to be warranted. Current preoperative education programs in the orthopaedic and neurosurgical domain typically rely on the biomedical model, including education about (spinal) anatomy and biomechanics (like done in 'back schools'), as well as detailing the surgical procedure. Preoperative education focussing on the biomedical model is ineffective, and can increase anxiety and fear of patients undergoing spinal surgery. Therefore, there is a need to reconsider the content of education provided to patients undergoing spinal surgery.

Patient recruitment. All patients scheduled for surgery for lumbar radiculopathy in the UZ Brussel will be invited to participate. Lumbar radiculopathy is defined as pain due to lumbosacral nerve root compression. The NICE guidelines describe this as unilateral leg pain worse than the current back pain. This pain radiates to the foot or toes, and goes together with numbness and paraesthesia in the same distribution, which is associated with motor neurological deficit. Patients undergoing surgery for lumbar radiculopathy (n ≥ 100), willing to participate (including willingness to comply with the predetermined follow-ups), are recruited.

Randomization and concealment Randomization will be done by a computer-generated randomization list. A list with patient numbers and the group allocation that results from this randomization procedure will be stored in a sealed envelope. All the assessments will be performed by the same two investigators.

Intervention. At least 50 patients undergoing surgery for lumbar radiculopathy should get the experimental treatment, i.e. perioperative pain neuroscience education (PPNE). All patients will receive usual care plus surgery for lumbar radiculopathy. PPNE will comprise of two treatment sessions delivered by one physiotherapist (verbal one-on-one) and an educational booklet. The first treatment session will be in the week before surgery, the second on day 2 following surgery. Each treatment session will last approximately 60 minutes.

Patients will receive pain neuroscience education and will have extensive possibilities to ask questions during the sessions. At the end of the first educational session, patients will receive the educational booklet about the neurophysiology of pain and will be asked to read it carefully once before and once following surgery. In addition, they will be asked to complete the interactive part in the book before the second session. The second educational session (postoperative) is highly individually-tailored as it will readdress the patient's illness perceptions, answers questions and discuss the way of applying the knowledge into the patient's daily life. Immediately after the second educational session the participants will be asked to complete the Neurophysiology of Pain Test.

Control intervention. At least 50 patients should undergo the control treatment. As is the case with patients from the experimental group, patients in the control group will receive usual care plus surgery for lumbar radiculopathy. In addition to this standard treatment received by all patients included in the study, they will receive back school. The amount of therapist-patient contact, the number of treatment sessions as well as the mode of administration will be identical in both treatment groups. The procedure of the control treatment is identical to the experimental treatment, apart from the content of the treatment, which is based on the clinical guidelines and several studies. The education covers the normal course of back pain.

Data collection. All assessments will be performed in the UZ Brussel. Baseline assessments will take place during the week prior to the surgery. Immediate treatment effects will be assessed at post-operative day 3. Short-term and intermediate follow-up assessments will take place at, respectively, 6 weeks and 6 months post-surgery. Twelve and 24 months after the surgery the long-term follow-up treatment effects will be investigated.

Statistical analysis. At baseline, correlation analyses will be performed in order to examine possible associations between preoperative endogenous analgesia and the psychological factors.

All postoperative data analyses will be based on the Intention-to-Treat principle (i.e. the baseline observation carried forward method). AN(C)OVA repeated measures analyses will be used to evaluate and compare treatment effects. Baseline data of the outcome measure of interest, age and gender will serve as covariates. Statistical, as well as clinical significant differences will be defined and the effect size will be determined. In addition, numbers needed to treat will be calculated. Again, correlation analyses will be performed to evaluate whether changes in any of the outcome measures are related to changes in the psychological factors.

Eligibility criteria: Inclusion Criteria:

* Surgery for radiculopathy
* Speaking and reading Dutch fluently
* 18-65 years old
* Continuing usual care ( no new treatment) 6 weeks preceding surgery and during trial

Exclusion Criteria:

* Surgery for another condition than radiculopathy
* Symptoms of cord compression
* Rheumatoid, endocrinological, neurological or psychiatric disorder
* Chronic illness characterized by chronic pain that is not under control
* New treatments 6 weeks preceding surgery
* Pregnancy (preceding year)

Primary outcomes:
measure: Self-reported pain assessed by the Visual Analogue Scale
timeFrame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
measure: Electrical pain threshold measured with an constant current electrical stimulator (DS7A Digitimer)
timeFrame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
measure: Endogenous pain inhibition assessed by the conditioned pain modulation paradigm
timeFrame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
measure: Quantitative Electroencephalography (QEEG) for brain mapping
timeFrame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
Secondary outcomes:
measure: Postoperative healthcare expenditure for lumbar radiculopathy will be investigated by consultation of medical notes.
timeFrame: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months
measure: Functional status and well-being with the Short Form Health Survey-36 items
timeFrame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
measure: Surgical experience assessed with statements about patients their spinal surgery/education experience with a level of agreement on a numerical scale from 1 "minimal" to 10 "maximal agreement".
timeFrame: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months
measure: Pain catastrophizing with the Dutch translation of the Pain Catastrophizing Scale
timeFrame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
measure: Pain hypervigilance with the Dutch Pain Vigilance and Awareness Questionnaire.
timeFrame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
measure: Kinesiophobia with the Tampa Scale for Kinesiophobia
timeFrame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
measure: Socio-economic factors with a demographic questionnaire concerning their return to work, professional occupation, incomes and grade of education.
timeFrame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
measure: Self-reported healthcare expenditure for which diaries will be used.
timeFrame: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Duffel
country: Belgium
facility: Sint-Maarten
state: Antwerpen
city: Geel
country: Belgium
facility: AZ Sint-Dimpna
state: Antwerpen
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
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