Effect of Integrated Exercise Protocol in Lumbar Spinal Stenosis as Compare with Conventional Physiotherapy- A Randomized Control Trial

Background context: Lumbar Spinal Stenosis (LSS) is one of the most common spinal pathologies in India. Spinal stenosis is narrowing of the spinal canal with encroachment on the neural structures by surrounding bone and soft tissue. While it is widely held that conservative management should be the first line of approach in patients with LSS, little is known about the efficacy of non-surgical treatments for this condition.


Introduction
Approximately 60% people of India have been suffering from low back pain. It is of two types: specific or non-specific [1]. Lumbar Spinal Stenosis (LSS) is recognized in about 20% of patients of LBP while it is attributed to lumbar disk herniation in 80% of cases [2].
The term spinal stenosis is defined as 'narrowing of the spinal canal with encroachment on the neural structures by surrounding bone and soft tissue' [3]. The effect of spinal canal stenosis becomes important only when it causes interference with the ache, leg pain etc. [4]. LSS can impact a person's quality of life, affect psychosocial wellbeing and significant cause of disability [5]. Spinal canal narrowing can be occur due to degenerative changes of spine which typically involved facet joint hypertrophy, ligamentum flavum thickening, degenerative spondylolisthesis and disc bulging etc. [6]. The signs and symptoms of LSS includes pain, paresthesias, numbness and weakness in the back and legs which occur due to entrapment of the lumbosacral nerve roots in the constricted neural canal and foramina [7].
Neurogenic claudication (NC) is one of the hallmarks of LSS which is described as the classic clinical presentation of progressive onset of radicular pain, paresthesias, numbness, weakness. LSS is classified; according to anatomically and on the basis of its etiology [8,9]. Anatomically it is of two types central and lateral; Central stenosis can be caused by posterior disc bulging, thickening of the ligaments, osteophytic outgrowth of the facet joints, degenerative spondylolisthesis and retrolisthesis. Lateral stenosis can be caused by lateral disc bulging, asymmetrical loss of disc height, osteophytic overgrowth of the pedicles and superior lumbar facets.
On the basis of etiology it maybe; Primary stenosis involves narrowing caused by congenital malformations, defects in postnatal development and secondary stenosis, the spinal canal is developmentally normal, but becomes narrowed because of an acquired conditions like degenerative changes, spondylolisthesis, postsurgical scarring, lumbar intervertebral disc herniation, or combinations of these conditions [10]. Another two main is developmental and degenerative [4].
The diagnosis of LSS is based on the clinical history and findings on physical examination and imaging is often necessary in patients with LSS to determine the exact level and the severity of the stenosis [6,11]. MRI or CT scan is widely used diagnostic tools which confirm the presence of spinal stenosis [12]. The Radiological criteria for lumbar spinal stenosis (L1 to L5) according to location of the stenosis through MRI [13].
A variety of conservative and non-conservative treatments are used for the treatment of LSS. In some cases surgical techniques are preferred to treat patients with LSS in which persistent symptoms are not adequately controlled by conservative/therapeutic modalities [14]. The Conservative management includes NSAIDS and exercise programs to strengthen musculature surrounding the low back region [15]. Physical therapy is accepted conservative [16]. There are lack of evidence in support of commonly utilized conservative interventions continues to result in lack of clarity regarding what intervention should be utilized to manage patients with LSS [17]. So, there is a need to establish the optimal rehabilitation treatment strategy for lumbar stenosis patients, as the comprehensive non-operative treatment provides better results to manage the LSS which improve the health status of the patient with least side effects and problems [18].
So the aim of the present study is to find out the effect of integrated exercise protocol on LSS as compared with conventional treatment.

Materials and Method
Nature of the present study is a Randomized Control Trial (RCT). The method of sampling was random sampling. 30 subjects between the age group of 25-50 years diagnosed as a Lumbar Spinal Stenosis through MRI Findings (AP diameter ≤ 12 mm) were included in the study. We determined the total random sample of n=30 [Group A, (experimental group) n=15 and Group B (control group) n=15] considering the following inclusion criteria   Patients meeting any of the following criteria were excluded: 1. Patient with Spinal surgery.

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Any concurrent major disease such as cancer, diabetes, renal failure, tumor.

Pregnancy
Before the commencement of the study, each subject included in the study was given information about the study and after attaining their interest, a written consent was signed from every participant. The protocols and research methodology and sample collection were approved by the department and ethical committee of physiotherapy Punjabi university Patiala, Punjab. All baseline information was obtained before randomization. Patients were scheduled for 45 to 60 min physical therapy sessions over 3 weeks (5 days a week). For one group Flexibility exercise, Specific experimental canal enlargement exercise, strengthening exercise, functional or Re-creational activities and for other group hot outcome measures (Perceived recovery was assessed with an Oswestry Disability Questionnaire (ODQ). Secondary outcomes included: Numeric Pain Rating Scale (NPRS), Straight Leg Raise (by goniometer), Slump test (by goniometer) and Modified Schober Test (MST) were recorded on 11 th day of intervention and 22 nd day of post intervention (Table 1).

Results
Data was analysed with appropriate statistical tool using SPSS version 20.0 for window 7 were included in the study, the majority of subjects were males 20 patients (66.7%) and only 10 patients (33.3%) were female. Mean age is 38.53 ± 8.37. Independent t-test used to evaluate the significance of difference between mean of two quantitative variables. The cut of level of significance was set at α=0.05 (Figures 1-6).     In strengthening exercises core muscle should be engaged.

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If patient can't perform exercise, the exercises will shift to another day.  Table 2 presents the improvement in QOL in ODQ measure by the two interventions used in the study. The Mean and SD on Pre intervention and post intervention at 11 th and 22 nd day for Group A was 61.29 ± 12.87, 42.77 ± 7.90 and 20.41 ± 4.76, respectively. In Group B, intervention and post intervention at 11 th and 22 nd day respectively. The mean difference between pre intervention and post intervention at 22 nd day of group A and Group B was 40.87 ± 10.81 and 7.26 ± 4.56, respectively (Figure 7). Table 3 shows the Comparison of ODQ mean value at Pre, 11 th day, 22 nd day and their MD (Pre -22 nd day) between Group A and Group B at 95% level of significance. The t value at pre and post intervention at 11 th and 22 nd day was 0.306, -2.953 and -7.343 respectively between ODQ scores of Group A and Group B. The Mean Difference for Group A Vs. Group B was 11.096 which signifies that group A has more significant improvement than Group B. Table 4 presents the improvement in Pain in NPRS measure by the two interventions used in the study. The Mean and SD on Pre intervention and post intervention at 11 th and 22 nd day for Group A was 7.60 ± 0.99, 4.93 ± 0.80 and 2.13 ± 0.83, respectively. In Group B, the mean and SD value of NPRS was 6.73 ± 1.58, 6.13 ± 1.46 and 5.40 ± 1.45 at pre intervention and post intervention at 11 th & 22 nd day, respectively. The mean difference between pre intervention and post intervention at 22 nd day of group A and Group B was 5.47 ± 0.64 and 1.33 ± 0.49 respectively. Data graphically shown in Figure 8 which is as follow:        Table 6 shows the Comparison of MST mean value at Pre, 11 th day, 22 nd day and their MD (Pre -22 nd day) between Group A and Group B at 95% level of significance. The t value at pre and post intervention at 11 th and 22 nd day was 0.306, 2.267 and 5.367 respectively between MST scores of Group A and Group B. The Mean Difference for Group A Vs. Group B was 3.895 which signifies that group A has more significant improvement than Group B. Table 7 shows the Comparison of SLR mean value on right and left leg respectively at Pre, 11 th day, 22 nd day and their MD (Pre -22 nd day) between Group A and Group B at 95% level of significance. The t value of SLR score for the right leg at pre and post intervention at 11 th and 22 nd day was 1.333, 2.076 and 3.758 and for the left leg 0.075, 2.343 and 4.691, respectively between SLR scores on right leg of Group A and Group B. The Mean Difference for Group A Vs. Group B for right leg was 1.581 and for left leg was 2.837, respectively, which signifies that group A has more significant improvement than Group B. Table 8  show no significant improvement whereas 22 nd day shows significant improvement for both right and left leg. The Mean Difference for Group A Vs. Group B for right leg was 6.564 and for the left leg was 5.314 respectively, which signifies that group A has more significant improvement than Group B.

Discussion
Lumbar MRI was the standard procedure for the demonstration of stenosis [19]. In the present study, a total 30 subjects with mean age (in years) 38.53 ± 8.37 were participated in the study in which 10 were females and 20 were males. The Mean and SD of age (in years) for Group A (Experimental) and Group B (Control) were 37.47 ± 7.78 and 39.60 ± 9.08, respectively. The mean age of the subjects included in the study signifies that LSS were commonly occur after the 3 rd decade of life while physiology supports that the LSS commonly occurs after the 6 th decade of life as a result of degeneration. The reason behind the early occurrence of LSS was sedentary lifestyle, occupation, smoking habit and ergonomically challenges posture [20].
The present findings were similarly attained by the Reiman et al. [17], in his systematic review which shows that by using TENS to improve intensity of pain among LSS patient. In Group A, Cryotherapy was used to improve the intensity of pain among LSS patient. The application of cryotherapy reduces the intensity of pain by the means of pain gate mechanism and also decrease the inflammatory response associated with cause of LSS [21]. Cryotherapy was helpful in relieving in decreasing intensity of pain among Low back pain. The similar findings      were observed by the Dehghan and Farahbod [22]. The conventional physiotherapy management was mainly focused on electrotherapeutic modalities and least on exercise therapy whereas integrated exercise protocol was based on cryotherapy and exercise regime to improve the spinal stability through strengthening the muscles. Present study was done to find out that an integrated exercise protocol was better than the conventional physiotherapy management for LSS patients. In group B, to improve the ROM of the Lumbar spine, the electrotherapeutic modalities along the exercises like knee to chest, pelvic rotation and pelvic bridging were used. It causes the stretching of para-spinal musculature and helps in improving lumbar ROM. there was a significant difference between the base line and post intervention score on MST i.e. there was improvement in ROM of lumbar flexion in group B. it was supported by Creighton et al. [9] and Reiman et al. [17] in their studies. There was a significant difference between the base line and post intervention score on MST i.e. there was improvement in ROM lumbar flexion in group A. The Straight Leg Raise (SLR) and Slump test was a common neurodynamic test used to examine the mechano-sensitivity of the lower extremity nervous system in individuals with low back or lower extremity pain [23,24]. So, in the present study, Slump test and SLR Neural Flexibility was used as an outcome measure to evaluate the effectiveness of conventional physiotherapy management and integrated exercise protocol on neural flexibility among LSS patients. There was a significant difference between the base line and post intervention score on SLR right and left leg i.e. there was improvement in neural flexibility in group B. That there was a significant difference between the base line and post intervention score on ST right and left leg i.e. there was improvement in neural flexibility in group B.
The QOL of the patients was hampered in LSS patients due to pain and associated symptoms which leads person dependent on others for their ADL's. In the Present Study, the Oswestry Disability Questioner (ODQ) was used to measure the disability occur due to LSS on the 5 levels of disability. It reveals that there was a significant difference between the base line and post intervention score on ODQ i.e. there was improvement in QOL in group B. It reveals that there was a significant difference between the base line and post intervention score on ODQ i.e. there was improvement in QOL in group A. The present findings were similarly attained by some researchers who concluded that the lumbar flexion exercises has been helpful in improving Quality of life of LSS patient. Creighton et al. [9] and Fritz et al. [25] shows significant physiotherapy intervention has effect in improvement of Quality of life among LSS patient.

Conclusion
In the present study the effect of an integrated approach and conventional physiotherapy treatment on LSS patient was evaluated. It has been found that the integrated exercise approach has a significant effect in improving pain, lumbar ROM, neural flexibility and Disability then a conventional physiotherapy treatment. So it has been concluded from the present study that the integrated exercise approach was better than conventional physiotherapy treatment.