Condition category
Musculoskeletal Diseases
Date applied
24/02/2019
Date assigned
12/03/2019
Last edited
12/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

https://www.unica.it/unica/it/dip_scienzemedsanpub.page

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

Publication citations

Additional files

Editorial Notes

04/03/2019: Trial’s existence confirmed by IRB