Plain English Summary
Background and study aims
Possible surgical criticisms to Failed Back Surgery Syndrome (FBSS) onset have been outlined pre-operatively, intra-operatively, and postoperatively. Successful clinical results are expected by the appropriate treatment of these problems. However, authors suggested a role for multidisciplinary rehabilitation when specific reasons for persisting pain are absent, but disability, mood disorders, or maladaptive thoughts co-exist post-operatively. Despite multidisciplinary programmes based on exercises and cognitive-behavioural therapy being increasingly used in subjects with chronic low back pain, there are doubts about their clinical impact when conducted in FBSS populations as well as their long-term effects. Therefore, evidence is still required in defining the characteristics of exercises and cognitive-behavioural interventions. Hence, we decided to undertake this trial based on the premises above.
Who can participate?
Adults, both males and females.
What does the study involve?
An enriched programme incorporating multimodal exercises and CBT in comparison with general physiotherapy alone in the treatment of FBSS.
What are the possible benefits and risks of participating?
Clinically significant improvements in disability, pain, and quality of life. No side effects are expected.
Where is the study run from?
From the Operative Unit of the Scientific Institute of Lissone, Monza Brianza, Italy).
When is the study starting and how long is it expected to run for?
From the beginning of 2012 to the end of 2016.
Who is funding the study?
University of Cagliari, UNICA, Italy
Who is the main contact?
Marco Monticone, marco.monticone@unica.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Marco Monticone
ORCID ID
http://orcid.org/0000-0002-6526-888X
Contact details
Dept. Medical Sciences and Public Health - Faculty of Medicine - Cittadella Universitaria
S.S. 554
Bivio Monserrato - Sestu
Cagliari
09042
Italy
+39.0706753109
marco.monticone@unica.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
20/2011
Study information
Scientific title
Multimodal exercises integrated with cognitive-behavioural therapy improve disability of subjects with failed back surgery syndrome: A randomized controlled trial with one-year follow-up.
Acronym
Study hypothesis
A 10-week rehabilitation programme of multimodal exercises integrated with cognitive-behavioural therapy would induce clinically significant improvements in disability, pain, and quality of life in subjects with failed back surgery syndrome vs. general physiotherapy, and that these would be maintained at least one year.
Ethics approval
Approved 12/11/2011, Ethical Committee Salvatore Maugeri Foundation (Via Monsignor Ennio Bernasconi, 16, 20851 Lissone MB, Italy; +39 039 46571; marco.monticone@fsm.it), ref: 20
Study design
Randomised, parallel-group superiority-controlled trial.
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 contact details to request a participant information sheet.
Condition
Lumbar pain, with or without leg involvement, following lumbar surgery (failed back surgery syndrome).
Intervention
Experimental group. Multimodal and task-oriented exercises and cognitive-behavioural therapy.
Control group. Passive spinal mobilisation, strengthening, muscle segmentary stretching, and postural control.
Randomization: the biostatistician randomized the subject to one of the two treatment programmes using a permuted-block randomization procedure. The list of treatment codes was previously generated and stored in Matlab and an automatic assignment system, also developed in Matlab, was used to conceal the allocation
The treatment programme took place at the outpatient rehabilitative gym at the hospital and was led by two physiatrists, a psychologist, and two equally-experienced physiotherapists.
During the treatment period, the questionnaires were administered by secretarial staff who checked them and returned any uncompleted part to the subjects for completion. At follow-ups, the patients were contacted personally by the same secretarial staff in order to ensure that the questionnaires were properly completed.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Disability was assessed using the validated Italian version of the self-reported 10-item Oswestry Disability Questionnaire (ODI) at baseline, 10-weeks and 12-months.
Secondary outcome measures
1. Kinesiophobia was assessed using the validated Italian 13-item version of the self-report Tampa Scale for Kinesiophobia (TSK) at baseline, 10-weeks and 12-months.
2. Catastrophising was evaluated by means of the 13-item validated Italian version of the self-reported Pain Catastrophising Scale (PCS) at baseline, 10-weeks and 12-months.
3. Pain intensity was assessed using an 11-point numerical rating scale at baseline, 10-weeks and 12-months.
4. Quality of life was assessed using the Italian version of the self-report Short-Form Health Survey (SF-36) at baseline, 10-weeks and 12-months.
5. Patient-rated efficacy of treatment using the Global Perceived Effect scale (GPE) at end of treatment.
Overall trial start date
31/10/2011
Overall trial end date
30/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Presence of lumbar pain, with or without leg involvement, following lumbar surgery
2. Lumbar surgery occurred once or more, being within the first (if more interventions, in the last) postoperative year
3. Good understanding of Italian
4. Age of >18 years
5. Expert spinal surgeons confirmed the accuracy of their pre-op diagnoses and excluded new surgical indications for pain persistence, such as the presence of residual lumbar foraminal and/or central stenosis, residual painful disc, epidural fibrosis, improper screw placement, non-union or abnormal motion at a fusion level, before sending for conservative treatment.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
135
Total final enrolment
130
Participant exclusion criteria
1. Cognitive impairment (MMSE<24)
2. Specific causes of LBP, such as deformity, infection, fracture or malignancy, unstable cardiovascular and pulmonary diseases, and systemic or neuromuscular diseases, ruled out by means of case histories and imaging.
3. Previously received workers’ compensation
4. Previously received CBT
Recruitment start date
01/01/2012
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Italy
Trial participating centre
Scientific Institute of Lissone
Via Monsignor Bernasconi, 16
Lissone (Monza Brianza)
20851
Italy
Sponsor information
Organisation
Dept. Medical Science and Public Health - Faculty of Medicine
Sponsor details
Cittadella Universitaria
S.S. 554
Bivio Monserrato - Sestu
Cagliari
09042
Italy
+39.0706753120
mloi@amm.unica.it
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Università degli Studi di Cagliari
Alternative name(s)
University of Cagliari, UNICA
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Italy
Results and Publications
Publication and dissemination plan
Peer-reviewed journals with special interest to spinal disorders.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list