Early management of psychological factors for subjects with sub-acute low back pain.
| ISRCTN | ISRCTN55789697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55789697 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 21/2011 |
| Sponsor | Dept. Medical Science and Public Health - Faculty of Medicine |
| Funder | Università degli Studi di Cagliari |
- Submission date
- 24/02/2019
- Registration date
- 26/06/2019
- Last edited
- 10/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
It is increasingly recognised that psychological factors such as maladaptive beliefs, fear of movement and catastrophising play an important role in the transition from acute to chronic pain and the development of disability of subjects suffering from back complains Maladaptive coping and behaviour strategies are also found to be risk factors of persistent back complaints. Recently, a Cochrane review found that multidisciplinary bio-psychosocial rehabilitation induces pain reduction, disability improvement, favours return-to-work and fewer sick leave days when compared to usual care. However, current research yielded studies with low to very low-quality evidence, and poor effect sizes in terms of clinical meaningfulness. Therefore, additional high-quality trials were recommended before this approach can be implemented in clinical practice. Therefore, we decided to undertake this trial.
Who can participate?
Adults, both males and females.
What does the study involve?
A multidisciplinary rehabilitative programme incorporating psychological interventions based on patient-reported questionnaires targeted at the detection of main maladaptive thoughts and behaviours in comparison to general physiotherapy alone in the treatment of subacute LBP.
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?
Scientific Institute of Lissone, Via Monsignor Bernasconi, 16, Lissone, Italy
When is the study starting and how long is it expected to run for?
January 2013 to December 2014
Who is funding the study?
Dept. Medical Science and Public Health - Faculty of Medicine, University of Cagliari, Italy
Who is the main contact?
Dr. Marco Monticone, marco.monticone@unica.it
Contact information
Scientific
Dept. Medical Sciences and Public Health - Faculty of Medicine - Cittadella Universitaria
S.S. 554
Bivio Monserrato
Sestu
Cagliari
09042
Italy
 ORCID ID |
0000-0002-6526-888X |
|---|---|
| Phone | +39 0706753109 |
| marco.monticone@unica.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized parallel-group superiority-controlled trial. |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Early management of psychological factors reduce disability of subjects with sub-acute low back pain. Results of a randomized controlled study with one year follow-up. |
| Study objectives | A 10-week program based on early management of psychological factors integrated to task-oriented exercises would induce clinically significant improvements in disability, pain, and quality of life in subjects with subacute LBP vs. usual care, and that these would be maintained at least one year. |
| Ethics approval(s) | Approved 18/12/2011, Ethical Committee Salvatore Maugeri Foundation (Via Monsignor Ennio Bernasconi, 16, 20851 Lissone MB, Italy; +39 039 46571; marco.monticone@fsm.it), ref: 21 |
| Health condition(s) or problem(s) studied | Subacute low back pain |
| Intervention | Experimental group. Task-oriented exercises and cognitive-behavioural therapy aimed at modifying wrong beliefs and behaviours concerning subacute pain. Control group. exercises for 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. Treatment took place at the outpatient rehabilitative gym at the hospital, delivered 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-up, the subjects were contacted personally by the same secretarial staff in order to ensure that the questionnaires were properly completed. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Disability assessed using the validated Italian version of the self-reported 10-item Oswestry Disability Questionnaire (ODI) before interventions, 10 weeks later (post-training), and 12 months (12M follow-up) after the end of treatment |
| Key secondary outcome measure(s) |
Before interventions, 10 weeks later (post-training), and 12 months (12M follow-up) after the end of treatment |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 135 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Sub-acute (i.e., a documented history of pain lasting from 4 weeks to up to 12 weeks) non-specific low back pain attending our rehabilitation hospital 2. Good understanding of Italian 3. Age < 18 years |
| Key exclusion criteria | 1. Acute (lasting up to 4 weeks) and chronic LBP (lasting > twelve weeks) 2. Cognitive impairment (MMSE<24) 3. All causes of specific LBP, such as previous spinal surgery, deformity, infection, fracture or malignancy, unstable cardiovascular and pulmonary diseases, and systemic or neuromuscular diseases, ruled out by means of case histories and imaging 4. Previously received cognitive-behavioural therapy |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
Lissone (Monza Brianza)
20851
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/06/2020: The total final enrolment was added.
11/03/2019: Trial’s existence confirmed by IRB
