Quality of life in osteoporotic patients with low-grade degenerative spondylolisthesis

2.1 Design

We conducted a single-blinded randomized controlled trial (Fig. 1) during the period January 2019–February 2020 in the rehabilitation departments of the University of Medicine and Pharmacy, Craiova, Romania. Fifty two osteoporotic females with lumbar DS were randomly including in two groups (study group—SG and control group—CG), and were homogeneous in terms of biographical and disease features.

Fig. 1.Diagram of our study. DS: Degenerative spondylolisthesis.

The inclusion criteria considered when designing the groups were:

Patients older than 55 years of age, known to have postmenopausal Op and recently diagnosed with DS.

We performed patient randomization via a computer-generated list. Only the physical therapist was aware of the group allocation of each subject. The other members of the rehabilitation team and the patients had no information concerning the randomization and we respected the Recommendation for Interventional Trials (SPIRIT) guidelines [19].

2.2 Patient assessment

We completed an initial clinical, laboratory and functional assessment which included:

General physical examination.

During the examination, we conducted standard laboratory tests and radiological examinations of the lumbar column (Fig. 2. Lumbar spine-lateral incidence). We used the Wiltse-Newman classification of SD [20].

Fig. 2.Lumbar spine-lateral incidence. 7 mm DS L4–L5 with the thought of the disk space. Mild lumbar scoliosis. Accentuation of lumbar lordosis. Posterior interopophyseal osteoarthritis L4–L5, L5–S1.

All 52 females underwent dual energy X-ray absorptiometry (DXA) for the determination of actual level of bone mineral density of the lumbar spine, using a stratos densitometer. The standard anteroposterior L1–L4 scanning permitted the establishment of a T-score for each vertebra and a total T-score (Table 1).

For the functional assessment, we used:

The VAS—Visual Analogue Scale (from 0 to 10, 0 = absence of pain and 10 = maximum pain score, other values between 0 and 10 were directly proportional to the intensity of pain, depending on the individual pain threshold).

Outcomes for VAS, SRM and SF-MOS scores were measured at admission to inpatient rehabilitation (T1), after 4 weeks (T2), and 6 months (T3) following the commencement of rehabilitation. These time points were chosen to adequately measure the rate of improvement in all outcome measures (mentioned in Table 1).

2.3 Patient rehabilitation

The rehabilitation program was performed in the two following phases:

Inpatient period: when patients had the ability to perform some kinetic tasks (mentioned in Table 2) we considered were able to be discharge from hospital.

The healthcare objectives were adapted for all patients and rehabilitation phases:

Painful status control.

Rehabilitation program was complex and included:

Pharmacological measures—analgesics, anti-inflammatory drugs, vitamin D and oral bisphosphonates, for the improvement of Bone Mineral Density (BMD) and bone microarchitecture [23].

All patients from SG performed exercises to combat pain, and increase flexibility and endurance of the trunk muscles and return to functional daily activities. Each exercise session was supervised and performed twice daily, 5 days/week, 3 weeks. The a.m. kinetic program (5 minutes warm-up, 20 minutes flexibility and strength exercises, 5 minutes cool-down) was preceded by TENS and LLT, and the p.m. kinetic program (5 minutes warm-up, exercises for return to functional activities, 5 minutes cool-down) was preceded by 20 minutes of magneto therapy. Between exercise programs, SG patients used a thoraco-lumbar brace, to reduce the load on the lumbar spine.

2.4 Statistic data

Data were recorded using Microsoft excel files; statistical analyses were performed using MS excel (Microsoft Corp., Redmond, WA, USA), together with the XLSTAT (Version 14, Addinsoft SARL, Paris, France). add-on for MS excel (Addinsoft SARL, Paris, France). Descriptive analysis of the study groups was performed with MS excel. Statistical tests (Student’s t-test and ANOVA) were performed using the XLSTAT addon.

We used Student’s t-test to compare study and control groups for each measured variable and each time, and ANOVA to compare the three sets of results obtained for each measured variable over time.

4.1 Pathogenic assessment

Both Op and DS are skeletal disorders, having the potential for mutual pathogenic conditioning. Decreased structural strength of the bone in Op [16] can exceed the ability of vertebrae to carry a seemingly normal load and favors the abnormal biomechanical requests (micro architectural deterioration of bone tissue, bone remodeling, increased risk of fracture, degree of wear of facet joints). This process is accelerated by vertebral osteoarthritis [27], accelerated degeneration of discs and disc space narrowing [28] and general laxity of the paraspinal ligaments [27]. All these aspects are in accordance with the conclusion of a 2017 systematic review—role of the menopause as a trigger for accelerated DS development after the immediate postmenopausal phase in women [8]. Probably, inactivity in DS patients with more severe pain, leading to a larger bone loss, but the specific role of bone mineral density in lumbar degenerative disease is not very well understood [29].

In osteoporotic females, DS generated abnormal loading is a greater challenge for dynamic stabilization [30]. Two main biomechanical reasons might explain the relationship between SD and the risk of vertebral osteoporotic fractures in postmenopausal females. First, SD might be associated with an increased lumbar lordosis or thoracic kyphosis, an independent risk factor for vertebral osteoporotic fractures [31]. Second, kyphosis posture and age could lead to a sagittal imbalance of the spine [32] with compromised trunk muscle activation, leading to falls and vertebral osteoporotic fractures.

The physiological thoracic kyphosis and increased stresses at the anterior margins of the thoracic vertebral bodies in osteoporotic spines produce prominent wedging of the mid-thoracic vertebrae, subsequently exacerbating hyperkyphosis by anterior translation of the head and upper torso [33]. However, grade Ⅰ DS is less associated with balance deficits, which is similar to our findings. Probably, pelvic parameters, especially muscular strength, are involved in compensatory mechanisms [14].

Here, we have proven that the kinetic program has a real role in pain reduction. We performed muscle strengthening exercises for spinal stabilisation which ensure the maintainance of neutral pelvic alignment causing force transfer and thereby decreasing the amount of load to the area. In females with Op and DS, we have to pay more attention to the transverse abdominis and multifidus; their co-contractions provide a balanced effect on the spine. Kinetic programs including exercises for hamstrings and gluteal mucles is important to incorporate ergonomic movements into patient daily activities and the results were justified by the VAS and SRM values. We remarked a patient compliance for bracing, especially after we explained its benefical role for posture and movement pattern assistance of the spine. Therefore, patients were tought how to the keep spine safe. Moreover, in the rehabilitation programs, physical therapy measures allowed optimal pain control through the control of sympathetic vegetative tone, reducing muscle spasms, and increasing the production of endorphins, the natural pain killers.

4.2 Clinical and functional assessment

All females studied complained of symptoms that defined a clinical status allowing conservative treatment—dorsal and lumbar pain (exacerbated by repetitive rotation, and relieved by resting), intermittent unilateral radiculopathy weakness in the legs, numbness in lower extremities, similar to other studies [34, 35].

Various limitations of physical function and daily activities were explained by vertebral mal-alignment, due to osteoporotic fractures [36] and minimal L4–L5 lysthesis. The mean values of the study scales (SRM and SF-MOS) defined a minimal to moderate dysfunction of the lower limb. The mean values of the function scale scores after the rehabilitation program sustained this improved level in patient quality of life. Thus, the treatment began with conservative care, without surgical stabilization, with more thread than not exist a universal agreement regarding the optimal surgical approach for the treatment of degenerative SD in osteoporotic patients [37]. We realized that Op has become one of the most prevalent public-health concerns and a major medical problem [38].

4.3 Imaging assessment

Our patients were diagnosed with L4–L5 grade Ⅰ DS, the most frequent form of SD, since the last decade [29, 39].

All studies found that grade Ⅰ DS, was typically found at the L4–L5 level, followed by L3–L4 and L5–S1, and is more common in females over the age of 65 [40]. Also, anterior slippage up to 30% of the vertebral body was possible, in our study which represented 10.4 (mean value) in SG and 10.7 in CG, respectively. The plain radiographic features in our patients included the essential finding of SD on a lateral view of forward displacement of L4 on L5. We took into consideration that a “listhesis” represents a rotary deformity and not a simple forward displacement [8] and all had DS classified as Meyerding grade Ⅰ. None of the patients had progression of DS and the degree of slip on the follow-up radiograph was preserved.

We explored the lumbar segment of vertebral column (L1–L4) with a DXA scan, frequently used for defining Op noninvasively [41] in all patients above 50 years, especially females [38]. In 2012, link mentioned that the association between altered vertebral BMD and spinal problems including spondylolisthesis, intervertebral disc degeneration, and osteoarthritis were investigated [42], but results were conflicting. Using DXA, higher spinal BMD was associated with a higher prevalence of SD; probably degenerative changes in the vertebral column developed over time may have led to false BMD results, especially for elderly patients [43]. Low BMD (DXA) might play a role in the development of the SD, as mentioned by Livshits et al. [44].

We assume that degenerative changes and shear stress affected mostly the L4 vertebrae and gave rise to an increase in BMD since SD and listhesis were mostly detected at this level. This result is similar to other studies [45].

4.4 Conservative treatment

In the females diagnosed with Op and DS there was reduced bone quality, poor stability of the spine, low back pain and various limitations in physical activity, prompting the need for treatment. The treatment began with conservative care, but if this did not benefit the quality of life, surgical stabilization may be needed. Proper conservative management in osteoporotic patients and rehabilitation measures to establish vertebral function is essential to prevent complications in low grade DS and osteoporotic spines [46]. We applied a complete rehabilitation program and surgical intervention was not necessary because the patient symptoms were controlled and no neurological impairment was highlighted. We did not study men where various slip ranges correlated with the level of exercise, physical activity, or daily walking [3]. For DS, positive results with nonoperative treatments were seen within lower grade slippages (grades 0, 1, 2), but patients were not diagnosed with osteoporosis, as were our subjects [47].

Our rehabilitation program has included physical therapy, kinetic exercises, and bracing. In the medical literature, we have not found other similar studies for osteoporotic patients with DS. In our opinion, physiotherapy before the kinetic program allowed optimal control of the pain dimension in the biopsychosocial model of our patients. It is well established that patients with persistent pain develop fear avoidance and maladaptive pain behavior, deterioration in physical performance and inactivity [48]. Also, the soft tissue becomes much better prepared for kinetic exercises with physiotherapy, especially in the back, pelvis, and paravertebral regions. Although, in patients with grade Ⅰ SD, pain relief and restoration of function can be achieved using conservative management techniques without the use of a brace [49], we considered that bracing is important in the rehabilitation program because all patients were osteoporotic females.

We applied kinetic exercises for complex dysfunctions of the vertebral column. Our kinetic program was a judicious choice for the two types of pathologies, more precisely a common denominator for reducing symptoms and restoring vertebral functionality. In accordance with Strength of Recommendation Taxonomy, Garet et al. [18] established that the exercise program in DS should focus on lumbar flexion, improving pain, self-reported recovery, and return to work versus exercises focusing on lumbar extension (level C) and strengthening specific abdominal/stabilizing muscles, improving pain and functional limitations in general exercises (level B) [18]. The kinetic exercises were chosen for controlling one of the major local reasons of DS, ineffectual muscular stabilization [50].

Exercise, as a nonpharmacological intervention for improving bone mass, has been studied extensively. The kinetic program in DS osteoporotic patients has been adapted both to the functional individual status and to conclusions of other studies. The specific strength training of stabilizing muscles utilizing functional tasks could be beneficial [18]. Spinal stabilization, that helps the patient in finding the neutral position of the spine, and hamstring stretches completed the previous exercises [51].

We could not perform structural spinal rehabilitation, to improve spinal alignment and postural distortions [52], because the vertebral bones had lost their normality, due to osteoporosis and paravertebral soft tissues had a general laxity. So, we preferred extension exercises for the entire vertebral column and hip extension from the prone position, range of motion and strengthening exercises focusing on lumbar flexion and strengthening specific abdominal muscles (isometric or isotonic), bracing for thoracic-lumbar regions, avoidance of stressful activities and educational measures on dynamic and static posture and lifting techniques. During the extension exercises for vertebral columns, the physiotherapist stretched the shortened muscles to enhance contraction of the antagonistic muscles, thus avoiding postural asymmetry; in this way, promoting the postural correction through specific stretching [53].

4.5 Surgical treatment

In recent years, a new surgical technique has been applied with excellent improvement in osteopenic patients (we studied osteoporotic patients) with low-grade isthmic SD (we analyzed low-grade DS) [54].

Spinal surgery in elderly patients with Op has been gaining support [26], but the surgical methods must be adapted if patients are associated with DS.

Many patients with DS and without significant neurological impairment are optimally treated without spinal surgery. If the patient’s clinical and functional status (pain, neurological signs) are persistent, then surgical intervention may be appropriate. The two most considered surgical options are decompression/laminectomy and stabilization/fusion (alone or in combination). In patients with grade Ⅰ or Ⅱ DS, surgery may be laminectomy alone, laminectomy/noninstrumented fusion or with an instrumented fusion.

In 2009, Lawhorne the 3rd and colleagues mentioned that over a third of operative cases of DS could be controlled with dynamic stabilization rather than decompression [1].

If DS patients are older and had Op, it is recommended that they have no fusion or a non-instrumented fusion (autograft harvested from the laminectomy that may or may not be combined with a bone graft expander combined with autogenous bone marrow aspirate) [40].

Today, various methods, for improving the materials used (polymethylmethacrylate, autogenous bone chips, various types of bone cement), and the design (screw fixation strength, diameter or length of the pedicle screw, cage) of devices, have been performed in osteoporotic patients with DS. A major dilemma is a fragile bone in DS patients and if the instrumentation with adequate biomechanical properties is not available, surgery could be contraindicated. All these strategies have potential disadvantages, and new techniques are needed to improve the safety and effectiveness of spinal surgery and spinal fusion for these patients [26, 29, 55].

Future research will be able to respond to some medical questions such as, what is the role of physical therapy, bracing, traction, or exercise in the treatment of DS [56] when it is associated with Op and what is the long-term result of this rehabilitation program.

4.6 Limitations of our study

A small number of patients, and only a single gender (females), relatively short duration of monitoring, and inclusion criteria that limited dysfunctional status.