A Study to Compare the Efficacy of Back Strengthening Therapy in Patients with Lower Back Pain on Analgesics to that of those on Placebo in a Tertiary Care Hospital in Chennai

Aim: Isometric and Core strengthening exercises for lower back pain provides relief to patients, whereas combing it with analgesics also provides relief of pain, thereby in this study the efficacy of isometric and core strengthening exercises alone is evaluated. Method: A cross-sectional study involving 200 subjects was conducted in the OPD of department of Orthopaedics, Saveetha Medical college and hospital. Assessment of lower back pain was done using ODI (Oswestry Disability Index) among patients receiving Isometric and Core strengthening exercises with and without analgesics for a period of 3 months. Results: There is no significance difference in the reduction of pain among group A who received analgesics along with isometric and core strengthening exercises and group B who received only isometric and core strengthening exercises. Conclusion: Isometric and core strengthening exercises alone is as effective as its combination with analgesics. Original Research Article Nehaapriya et al.; JPRI, 33(47B): 982-987, 2021; Article no.JPRI.75131 983


INTRODUCTION
Low back pain (LBP) is a common disorder involving the nerves muscles, and bones of the back [1][2][3][4][5][6][7]. Pain usually varies from a constant or intermittent, dull aching pain or sharp pricking type of pain. Low back pain can be classified based on duration as acute which last for less than 6 weeks, for 6 to 12 weeks as subchronic, or chronic which last for more than 12 weeks. Its further classified depending on the underlying cause as either mechanical, nonmechanical, or referred pain [8]. Low back pain is a common health problems in India with a prevalence of 60%, which results in functional loss that in turn reduces the productivity of individual and in turn country [9]. In 85% of patients with low back pain, the signs and symptoms are non-specific to any etiology and cannot be arrived at a clear diagnosis, treatment protocol or prognosis. A variety of conservative treatment modalities, such as medication, exercise and physical therapy are used in the treatment of low back pain. These techniques are imployed to reduce pain, increase mobilization and improve functional and psychological status of the patient which in turn increases the quality of life of the patient. Exercising is one of the mainstray treatments used for low back pain and has proven by various studies that it reduce the duration and frequency of lower back pain [10]. In this study we aim at evaluating the effectiveness of physical treatment modalities for pain relief and functional status of the patient with low back pain. Increasing strength of lumbar muscle is the most important therapeutic modality for the patient with LBP. Isotonic, isokinetic, and isometric exercise has been used to improve muscle strength and endurance of muscles in lumbosacral area. Isometric exercise is safe from injury and has potent efficacy for increasing muscle strength, and it can apply to the patients with motion limitation. Mat exercise is the most used type of isometric exercise, however this exercise has difficult in controlling muscle power [6].

METHODS
Study design and Duration -This was a crosssectional study conducted between January and March 2021 at Saveetha Medical College in Chennai, Tamil Nadu across 200 subjects with consent using a well instructed questionnaire which was validates by experts.

Inclusion -
The subjects participated in the study are healthy individuals with lower back pain above 18 years of age with no other spinal disease.

Exclusion -
The subjects not included for the study are patients with congenital disorder of spine, malignancy, previous surgery, compression fractures/ spinal cord compression, inflammatory arthritic conditions, acute infection, pregnancy, serious instability, osteoporosis, severe cardiovascular disorder and any other metabolic disease.
Study Procedure -After obtaining permission from IEC, patients with lower back pain who were willing to take part in our study after being read and explained the information sheet and signing the informed consent was interviewed with ODI questionnaire. The subjects were divided into two groups randomly each consisting of 100 subjects, one group (A) receiving analgesics that is NSAIDS (Non-steroidal anti-inflammatory drugs) along with Isometric and Core strengthening exercises where as group two (B) consist of subjects receiving only Isometric and Core strengthening exercises for a period of three months. The Isometric and core strengthening exercises given to patients include slide plank, Half-Kneeling Pall of Press, superman, Stretching, low impact aerobics, atc. Demographic details was noted. Procedure consist of answering a set of questions regarding lower back pain by themselves which was put forth by the investigator and patients answers for the same were noted and ODI were evaluated before and after treatment.

RESULTS
This study comprised of 200 subjects, which included 96 males and 104 females whose ODI score was measured before and after treatment. The comparison between group A (patients receiving analgesics along with isometric and core strengthening exercises) and group B( patients receiving only isometric and core strengthening exercises) was made with respect to their ODI score before and after treatment , to calculate the sample chi square was done.  Since the x 2 (group A) = 82.63 at p<.05 and x 2 (group B) = 79.33 at p <.05 , there is no significant difference exist between the ODI score measured from group A and group B at 5% level, the null hypothesis is accepted.

DISCUSSION
In this randomized controlled trial, it had been found that Isometric and core strengthening therapy for 3 months alone provided similar improvement in pain and functional status of patients thereto of Isometric and core strengthening therapy alongside analgesics like NSAIDs for 3 months. The aim of the treatment is to scale back pain, to enhance flexibility , to extend strength and endurance of the trunk stabilizers, to scale back tension, and to enhance mobility and posture, thereby, resulting in improved functional status, better ability to perform activities of lifestyle , and prevention of labor loss. Many methods like resting, medical treatment, exercise programs, physiotherapy modalities, and manipulation are utilized in the treatment of lower back pain [2]. During this study ODI (Oswestry Disability Index) score is employed within the assessment of pain and functional status of patient. In this study out of 200 subjects 23 subjects have undergone surgical intervention during the study and it had been found that similar improvement within the ODI score was obtained from both the groups ( A isometric and core strengthening therapy alongside analgesics, Bisometric and core strengthening therapy alone). Thereby it's proven that Isometric and core strengthening exercises alone is as effective as Isometric and core strengthening exercises alongside analgesics (NSAIDs). Whereas during a similar study conducted in Turkey to assess the effect of physiotherapy modalities on pain and functional status in patients with non specific low back pain, it had been found that there was significant improvement among patients after combined treatment with exercise, medical therapy, and physiotherapy was found to be simpler for nonspecific Chronic lower Back pain than exercise and medical therapy alone. During a article by Ali Hasanpour-Dehkordi compares pilates and McKenzie (MK) methods, within the MK group, participants performed 1-hour of workouts for 20 days while the pilates group practiced sessions 3 times every week for six weeks and both were compared with Control Groups. After therapeutic exercises, no big difference in pain relief was found between the pilates group and therefore the MK group (P=0.327) but an improvement in pain score was seen in both techniques in comparison to the Control Groups. In the study done by Jamil Natour, considered an impact groups with patients taking non steroidal antiinflammatory drug drugs (NSAIDs) and therefore the intervention group (IG) where pilates was used twice every week for 3 months additionally to NSAIDs. Pain improved within the IG also less NSAIDs than the Control groups [4]. In our study, we found that isometric and core strengthening exercises alone provide similar improvement in pain and functional status of patient as that of isometric and core strengthening exercises alongside analgesics, thus we will limit the utilization of analgesics for long duration , thereby avoiding its adverse effects. Even though analgesics have found to play an important role in alleviating acute pain, it can avoided for mild to moderate cases of lower back pain. In case of severe and chronic back pain, analgesics can be used to relief pain. Some studies have shown meditation can be an effective treatment for lower back pain. Developing the focus and ability to move your mind off the pain and onto something more soothing can decrease your discomfort. Plus, you may reduce the incidence of accompanying conditions such as anxiety and stress [4].

CONCLUSION
In accordance with many studies of chronic lower back pain, patients perceived significantly less pain after intervention, regardless of group allocation. Subjects randomly allocated group A who received analgesics along with isometric and core strengthening exercises had similar outcomes as subjects who were allotted to group B who received only isometric and core strengthening exercises. According to the results obtained in this study, both groups responded in terms of pain and that there was no difference between groups was found. Thus in conclusion, isometric and core strengthening exercises alone is as effective as its combination with analgesics. Thereby we can avoid the use of analgesics for long duration and prevents its adverse effects.

DISCLAIMER
The products used for this research are commonly and predominantly use products in our area of research and country. There is absolutely no conflict of interest between the authors and producers of the products because we do not intend to use these products as an avenue for any litigation but for the advancement of knowledge. Also, the research was not funded by the producing company rather it was funded by personal efforts of the authors.

CONSENT
As per international standard or university standard, patients' written consent has been collected and preserved by the author(s).

ETHICAL APPROVAL
Our study was duly approved by scientific review board and Institutional Ethics committee of our institute.