This study was carried out on 73 patients; their ages ranged from 21 to 45 years; they had chronic LBP with radicular pain caused by disc protrusion or herniation, as diagnosed by MRI of the lumbosacral spine, and the duration of the disease was more than 12 weeks . They were selected from outpatients attending the rehabilitation clinic in Abdul Latif Jameel Hospital for Medical Rehabilitation, Jeddah, Saudi Arabia, during the period spanning from January 2016 to September 2017; consent was taken from every patient for the treatment and to be included in this study. Patients with other causes of LBP, the presence of osteoporosis, vertebral fracture, displacement, weakness in the lower limbs, impaired sensation in both lower limbs or spondylolisthesis and pregnant women were excluded from the study. The patients were divided into two groups.
(1) First group: this group comprised a total of 39 patients, 23 (58.97%) male patients and 16 (41.03%) female patients; their ages varied between 21 and 43 years with a mean age of 32.06±7.09 years, and the duration of disease varied from 16 to 56 weeks, with a mean duration of 34.26±13.45 weeks. Their weights varied between 64 and 97 kg. This group underwent decompression using the DRX9000.
(2) Second group: this group comprised a total of 34 patients, 19 (55.88%) male patients and 15 (44.22%) female patients; their ages varied between 23 and 45 years with a mean age of 33.21±7.23 years, and the duration of disease varied from 18 to 53 weeks, with a mean duration of 32.43±12.22 weeks. Their weight varied between 61 and 93 kg. This group underwent physiotherapy including deep heating modalities and ordinary traction.
All patients were subjected to full history taking; clinical examination including site of tenderness, straight leg raise (SLR) test, motor and sensory assessment, and range of motion of the lumbar spine were carried out before and after completion of sessions. Visual analog scale (VAS) from 0 to 10 was used before and after completion of the treatment course for assessment of LBP during a flexion-extension range of motion and for assessment of radicular pain in the lower limbs. Radiological assessment included radiographic lumbosacral spine anterioposterior and lateral view and MRI lumbosacral spine to support a diagnosis of chronic discogenic LBP due to bulging, protruding or herniated intervertebral discs that may have been brought on by degenerative disc disease. MRI was also repeated after completion of the
treatment course to assess whether there were changes in disc height or not.
MRI was performed before the start of treatment and after the end of treatment using a 3.0 T magnetic resonance unit (MAGNETOM Verio, A Tim System; Siemens, Erlangen, Germany). The patients were positioned in the supine position and scans were performed: (a) sagittal T1 images from T12 to the sacrum (repetition time: 670 ms; echo time: 12 ms, slice thickness: 4 mm), (b) sagittal T2 images from T12 to sacrum (repetition time: 3000–3600 ms; echo time: 87–114 ms, slice thickness: 4 mm), and (c) axial T2 images from L1 to S1 (repetition time: 3000–3600 ms; echo time: 87–114 ms, slice thickness: 4 mm).
Intervertebral disc height
Intervertebral disc height of the lumbar spine was measured on midsagittal MRI from the middle of the superior border of the disc to the middle of the inferior border of the discwith theinclusion of both end plates. In our study,we detect the difference of disc height between two MRIs to avoid personal variation in disc height. Paired t-test or linear regression was used, as appropriate, with P less than 0.05 considered to be statistically significant.
(1) First group: a total of 39 patients receivedtreatment with the DRX9000 (Axiom Worldwide, Tampa, Florida, USA) according tothe intervention’s operating guidelines .
(2) Second group: a total of 34 patients receivedphysiotherapy including ultrasound,transcutaneous electrical nerve stimulation(TENS), and vertebral traction.
The protocol of the DRX9000 includes 20 sessions of spinal decompression over a 6-week period with 30- min active treatment sessions. Each patient was administered treatment five times per week for the first 2 weeks and three times per week for a further 2 weeks, and it was then tapered down to two sessions per week for the last 2 weeks. At the start of the session, the patient is fitted into the supine position. To start active treatment, the machine pulls the patient gently on the lower harness while the upper harness remains stationary, thus distracting the patient’s spine. A safety button can be pushed at any time by the patient to release all tension immediately. The initial decompression force was adjusted to patient tolerance, starting at 4.54 kg (10 lbs) less than half their body weight. If a patient described the decompression pull as ‘strong or painful,‘ this distraction force was decreased by 10–25%. In subsequent treatment sessions, the distraction force was increased as tolerated to final levels of 4.54–9.07 kg (10–20 lbs) more than half their body weight. After the end of each therapy session, a cold pack with electrical muscle stimulation was applied to help paravertebral muscles consolidate after treatment.