DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (\> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy.
Duration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).
Signed informed consent.
Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), paracetamol, opioids and myorelaxant.
Annulus fibrosus intact, demonstrated by MRI.
Pain baseline > 40 mm on VAS (0- 100).
Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis).
Spinal segmental instability assessed by dynamic X-Ray.
Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy evaluated at coronal T2 weighted MRI).
Oral corticosteroid therapy within the previous 3 months, OR
Parallel
Autologous BM-MSC
Drugintradiscal injection of autologous bone marrow mesenchymal stromal cells
Sham
Procedure/Surgerylocal anaesthesia, no disc injection, no placebo injection
Pain Change
Changes in pain will be evaluated on Visual Analogic Scale (VAS) between baseline and month 24. VAS scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable.
Functional disability index evaluation
Functional disability changes will be assessed on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 24 compared with baseline. ODI scale ranges from 0 to 50 and allows evaluation of disability (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms).
Disability evolution
Disability evolution includes Short Form-36 Health Survey (SF-36) scores. SF-36 scores consist of eight 0-100 scaled scores (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning and mental health) where a lower score corresponds to more disability and a higher score corresponds to less disability.
Quality of life evolution
Quality of life evolution includes global assessment by the patient and the physician. The global assessment by the patient and the physician involves evaluation of: - Overall pain intensity in the lumbar spine (1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme); - patient's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor); - physician's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor).
Drug consumption of rescue painkillers medication
The decrease/increase in the use of rescue medication will be recorded throughout the study duration by a diary file. A reduction in dose or frequency of administration of painkillers is an indirect marker of the benefits of MSC therapy.
Measurement of pain
Assessed by Visual Analogic Scale (VAS). VAS pain scale ranges from 0 to 100: where 0 represents no pain and 100 represents the worst pain imaginable. In brief, the patients will fill VAS tests indicating the amount of pain experienced at rest and in motion.
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Fondazione Policlinico Universitario Campus Bio-Medico
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator
Center for Outcomes Research and Clinical Epidemiology, Italy
Collaborator
