Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT01259167 |
| Other study ID # |
762/10 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
December 13, 2010 |
| Last updated |
December 13, 2010 |
| Start date |
January 2011 |
| Est. completion date |
June 2011 |
Study information
| Verified date |
November 2010 |
| Source |
Catholic University of the Sacred Heart |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Italy: Ethics Committee |
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study was to assess whether a training program based on Joba® Core
Trainer is effective in reducing pain and improving physical function and quality of life of
subjects suffering from Chronic Low Back Pain.
Description:
Background and rational
1. Definition Low back pain is a clinical condition characterized by pain felt between the
bottom edge of the costal arch and the inferior gluteus folds, sometimes radiating to
the back side of the thigh.
It may be responsible for functional limitation and inability to perform normal
activities of daily living. Low back pain is defined as acute if symptoms have a
duration less than 4 weeks, sub-acute if the duration is between 4 weeks and 3 months,
and chronic if it lasts beyond 3 months. It is considered recurrent when episodes
shorter than 4 weeks alternate with periods of relief from pain.
2. Epidemiology Low Back Pain is the most common musculo-skeletal disorder, and, along
with common cold, is the most frequent disease among humans.
Up to 60-80% of population is expected to suffer from Low Back Pain at some time in
life. Annual prevalence of Low Back Pain ranges from 30 to 50% amongst people in the
working period of their life; out of these individuals, a percentage between 15 and 20%
do necessitate medical assistance. Low Back Pain is the fifth-ranking cause of medical
referral and the second symptomatic condition. A proportion ranging from 25 and 50% of
patients with acute Low Back Pain will suffer from new pain episodes in the following
year and 6-10% will progress toward a chronic form.Chronic Low Back Pain is responsible
for about 75% of all medical expenses made for the treatment of all types of Low Back
Pain. Direct annual costs (medications, medical visits, physiotherapy,
hospitalizations) of Chronic Low Back Pain have been estimated to be approximately €
3.100 for patients (year 2002); indirect costs, mainly due to absence from work,
represent about 85% of total costs and match up about € 17.600 for patient for year. In
conclusion, Chronic Low Back Pain is a disease with very high prevalence and incidence,
evenly affecting men and women in their 30's and 50's, which is extremely costly for
individuals and society, both in terms of diagnostic interventions and treatments, and
of reduction of productivity and functional limitation in everyday life.
3. Non-Pharmacologic treatments Non-Pharmacologic treatments of Chronic Low Back Pain
include: acupuncture, back school, psychological interventions, functional restoration,
interdisciplinary rehabilitation, interferential therapy, low-level laser therapy,
lumbar support, massage, short wave diathermy, spinal manipulations, tractions,
superficial heat, transcutaneous electrical nerve stimulations (TENS), ultrasound
therapy, yoga and physical exercise.
A recent meta-analysis based on 43 clinical controlled trials involving 3.907 subjects
with Chronic Low Back Pain demonstrated that physical exercise is effective in reducing
pain and improving functional level. The most recent Guidelines, published in October
20007, underline that, along with cognitive-behavioural therapy, spinal manipulations
and interdisciplinary rehabilitation, physical exercise is the only non pharmacologic
treatment having a positive effect on Chronic (or subacute) Low Back Pain.
4. Vertebral instability and physical exercise Several theories link the etiology of Low
Back Pain clinical signs and symptoms to the mechanical instability of the lumbar
spine. Stability of the lumbar spine requires both passive stiffness, through the
osseous and ligamentous structures, and active stiffness, through "core" muscles, such
as rectus abdominis, external oblique, internal oblique, transversus abdominis,
quadratus lumborum, multifidi, psoas major, iliocostalis, gluteus major. It has been
shown that therapeutic exercise improves vertebral stability through stretching and
strengthening of "core" muscles, but also by enhancing neuromuscular proprioceptive
facilitation. This is the reason why physical exercise programs usually do include
strengthening and trunk-stabilizing exercises.
5. Joba® Core Trainer Joba® Core Trainer is a gym equipment which makes use of the
counterbalance principle to efficiently engage trunk muscles, including both abdominals
and trunk extensors. This equipment has been proved to be effective in improving
cardio-respiratory fitness level, increasing resting energy expenditure, reducing
weight and enhancing glycaemic control in diabetic patients. Furthermore it
significantly strengthens diverse muscular groups (abdominals, trunk extensors,
abductors, thigh flexors and extensors).
Thus Core Trainer Joba® may represent a valuable alternative to traditional physical
exercise protocols in the treatment of subjects with Chronic Low Back Pain
6. Study purpose The purpose of this study was to assess whether a training program based
on Joba® Core Trainer is effective in reducing pain and improving physical function and
quality of life of subjects suffering from Chronic Low Back Pain.
7. Materials and Methods 7a)Study design Randomized, one centre, single-blinded, clinical
trial with three arms: JOBA group (training with JOBA® Core Trainer), BACK group
(training with a traditional protocol of Therapeutic Physical Exercise) and Control
group with sedentary people undergoing usual care (C).
7b)Subjects Subject attending the Physiatrist and Geriatric Outpatient Clinics of the
Department of Gerontology, Geriatric and Physiatrist Sciences of the University Hospital
"Agostino Gemelli" (Rome, Italy) with non-specific Low Back Pain, with or without sciatic
irradiation, from at least 3 months. Exclusion criteria: functional or neurosensorial
limitations which contraindicate or impede attending a physical exercise program
(spondilolystesis higher than first degree, disk herniation more recent than 6 months, disk
herniation for which surgical intervention is indicated, previous surgical intervention on
spine, cognitive deterioration, terminal prognosis).
7c)Main outcome Perceived pain intensity. 7d)Secondary outcome
1. Quality of life
2. Level of physical function
3. Level of physical activity in everyday life
4. Neuro-muscular proprioceptive control of trunk-stabilizing muscles
5. Medication use/medical visits. 7e)Duration Twelve weeks.
8)Study phases 8a)Screening visit and enrolment Subjects to be enrolled into the study will
be individuated during visits carried out at the Physiatrist and Geriatric Outpatient
Clinics of the Department. Eligible subjects will be informed about the scope and methods of
the study; those who will accept to participate will sign informed consent.
8b)Baseline assessment Patients will undergo a thorough medical visit (medical history,
medication use, physical examination). The intensity of perceived low back pain, the level
of physical functioning, and the quality of life will be measured (Mc Gill Pain
Questionnaire-Short Form, Visual Analogue Scale, Roland-Morris Disability Questionnaire,
Short-Form 36, respectively).The level of physical activity in everyday life (daily energy
expenditure, physical activity >3 METs duration, active energy expenditure, average METs,
number of steps, etc.) will be assessed by means of Metabolic Holter (Armband®) for a period
of at least five consecutive days.Proprioceptive and neuro-muscular control of trunk muscles
will be evaluated by means of a stabilometric, computerized table(Libra®).
8c)Randomization Subjects will be allocated to one of the three study groups according to a
computerized randomization procedure with block of variable length.
8d)Intervention
1. JOBA Group: 3 sessions per week with JOBA® Core Trainer. Each session will last about
45 minutes (5-7 minute stretching exercises, 31' minutes with JOBA, 5-7 minute of
stretching exercises). Speed of JOBA movements will progressively increase during the
study period. All training session will take place in the Fitness Centre of the
University Hospital "A. Gemelli".
2. BACK Group: 2 sessions per week (55 minutes each) of calistenic gymnastic with
stretching, dynamic stabilization, and strengthening of trunk-stabilizing muscles,
according to a standardized training protocol under the supervision of qualified
technical personnel at the Fitness Centre.
3. Control Group (C): usual medical care according to the fore mentioned Outpatient Clinic
standards.
8e)Intermediate assessment After 6 weeks, pain intensity, physical functioning, and quality
of life will be re-evaluated; drug use and medical visits occurred from the baseline will be
recorded.
8f)Final assessment After 12 weeks, subjects will undergo a complete medical visit and a new
functional evaluation accordin to procedures already depicted for baseline (pain, physical
function, quality of life, physical activity, proprioceptive control of the trunk,
care-associated costs).
Blinding Due to the characteristics of the intervention, participants will be aware of the
specific group the are allocated to (either traditional training or JOBA or usual care).
However, baseline, intermediate, and final assessment will be carried out by a field
researcher (a medicine doctor) uninformed of the allocation arm of the subject.
Sample size According to literature data it has been hypothesized that the intervention will
produce a 20 (per cent) points increase in pain scale with respect to controls; using a
probability of type I error of 5% (alfa=0.05, single-sided) and a power of 80% (beta=0.20),
it can be estimated that each group should include 12 subjects (total sample size 12x3=36).
9)Analisi statistica Statistical analysis will be carried out on an intention-to-treat
approach. Statistical analysis will be carried out using statistical software package
SPSS/PC Vers. 18.
