The Effect of Back and Knee Recovery Device on the Severity of Signs and Symptoms of Patients with Discopathy: A New Approach to Patients with Discopathy Without Medication

Introduction:

Low back pain is one of the most common musculoskeletal pain conditions that prompts patients with discopathy to seek care (Zhu, 2020). According to the latest evidence, it is the fifth leading cause of patient visits to physician offices in the United States. Many people experience some degree of low back pain during their lifetime, with an estimated lifetime prevalence of 49–90%, which increases with age (Edward, 2018, Klump, 2017). Low back pain has been identified as a leading cause of disability and lost years of working life (Boisson, 2018). About 2/3 of patients will experience some degree of non-specific low back pain during their lifetime (Inani, 2013). This disorder can also be caused by trauma (Fiani, 2020). For years, discopathy was the leading cause of absenteeism from work and also the leading cause of medical rehabilitation (Cento, 2017). In recent years, musculoskeletal diseases have become the second leading cause of early retirement from the workplace after mental illnesses. On the other hand, this chronic pain can affect the quality of life of patients (Almano, 2019)

Since low back pain can cause disruption in daily life activities such as working (Inani, 2019), therapeutic and care interventions are necessary to reduce the severity of symptoms. Not all patients respond to medical treatments, therefore, the use of complementary therapies is essential (Almano, 2019). To alleviate the pain and symptoms of patients with musculoskeletal disorders that lead to back pain, such as discopathy, various clinical trials have been used, including the use of virtual reality in training movement exercises, which has been able to significantly reduce pain, improve sensory-motor function, improve cognitive function, and quality of life (Almano, 2019). Xu et al. (2020) and Wieland (2017) have also introduced the effect of yoga on short-term to medium-term (three to six months) pain and disability in patients with discopathy as beneficial and effective (Xu, 2020 and Wieland, 2017). The use of physical exercises is an effective method in patients with surgical treatment and conservative treatment, but Radziski (2018) reports in his study that in the follow-up of patients with discopathy with and without surgical treatment after 3 years of follow-up of patients, the amount of exercise reaches one to two hours per week. In patients undergoing surgery, 21.5% and in patients with conservative treatment, 16.8% performed their exercises as instructed, so in most patients, the level of follow-up and compliance decreases over time after discharge. Also, the level of physical exercise in the elderly is lower than in young and middle-aged people (Radziski, 2018). The results of these studies show that regular and continuous exercise is essential for patients with discopathy, and lack of follow-up and irregular exercise can reduce the effects of treatment, whether conservative or surgical (Dadenziski, 2013), therefore, the need for an intervention that provides appropriate and standard exercise for the patient under the supervision of a specialist is essential.

Another intervention that can be used in this field is the use of a new auxiliary treatment called the "Back and Knee Recovery Device (Kemerasa)" with the trade name (LKRD2000), which has been designed, manufactured, developed and patented in Iran. This device consists of two main parts: electronic and mechanical. The mechanical part is responsible for the traction function, and the electronic part is responsible for managing and planning the types of traction. This product has no restrictions for use by different groups in terms of age, gender, height, and weight.

Method:

This study was a two-group clinical trial study that measured the effect of using the back-knee recovery device in patients with lumbar and sacral grade 1, 2, and 3 discopathy on the severity of these patients' signs and symptoms. The intervention in question was the use of the "Kemerasa" traction device. The research population included all patients with lumbar and sacral grade 1, 2, and 3 discopathy and the research samples of discopathy patients who met the inclusion criteria. The research setting includes orthopedic clinics of Sina and Imam Hospitals of Tehran University of Medical Sciences and the Health and Wellness Clinic, where treatment with the Kemerasa traction device is performed.

Inclusion criteria

• Age between 18 and 60 years
• Diagnosis of lumbar and sacral discopathy grade 1, 2, and 3 by the attending physician
• Willingness to use the back and knee recovery device along with other treatments prescribed by the physician
• No other disease or abnormality in the spine

Exclusion criteria

• Worsening of the disease and progression to grade 4 discopathy
• Occurrence of any possible complications resulting from using the device
• Unwillingness to continue participating in the study Research

In order to conduct the research, after approving the design, code of ethics, and sampling permits, the researcher began sampling by visiting the research settings, considering the inclusion and exclusion criteria, and after explaining the objectives of the research to the patients. The intervention in question was the use of the Back and Knee Recovery Device (KamrASA). The random allocation of samples was done by considering the inclusion criteria and by drawing lots among those referring to the research settings (clinics of Sina and Imam hospitals). The random allocation of samples was as follows: After drawing lots, the control group received usual care, and the experimental group receivedThe intervention is referred to a center equipped with a lumbar device. The control group receives usual medical treatment and care, which includes daily exercise training, precautions to prevent recurrence, and pain relief measures such as using warm compresses, taking hot showers, avoiding stairs, and avoiding long distances. The experimental group receives the desired intervention in addition to routine treatment and care. The intervention method is that the person is slowly placed on the device in a chair position, and after initial adjustments such as sitting height and other controllable items, the person is slowly transformed from a chair position to a bed, and after fixing the upper and lower body, a different recovery program that includes various types of stretching is implemented. The stretching applied to the spine in terms of design and degree of freedom of the stretching angle minimizes damage even for high-risk individuals. The number of intervention sessions three times a week is a maximum of 30 to 35 sessions, which varies depending on individual differences and structures, including lifestyle, mental and psychological state, physical and stress. The intervention was performed by a trained technician.

In the test group, at the beginning of the study and before the intervention, after obtaining informed consent and explaining the research goals, the demographic information form and the visual scale for assessing pain intensity and comfort level and the katz-ADL tool for assessing activities of daily living were completed, and then at the end of the sessions, the intensity and comfort scale was completed again. In the control group, the demographic information form, visual pain and comfort scale, and the katz-ADL activities of daily living survey tool were completed at the beginning and end of the study.

Sample size

The sample size based on Altman's nomogram, test power of 0.8, and standard deviation of a similar article by Khanzadeh et al., which was conducted in 2012 on the effect of massage on back pain caused by lumbar disc herniation (Rezakhoz, 2012), was 35 people, and considering sample attrition, the number of samples was determined as 37 people in each control and test group.

Findings:

The findings showed that the research samples included (44%) 44 women and (56%) 56 men. Their mean age was 50.04 ± 13.19 in the range of (21-74) years. (18%) 18 people were single, (73%) 73 were married, and (9%) 9 were divorced. (19%) 19 people had high school education, (35%) 35 had a diploma, (34%) 34 had a bachelor's degree, and (12%) 12 had a master's degree. (13%) 13 were secretaries, (4%) 4 were unemployed, (31%) 31 were housewives, (37%) 37 were freelancers, and (15%) 15 were retired. (4%) 4 had a bad economic situation, (70%) 70 were average, and (26%) 26 were good. 2 patients had grade 1 discopathy, (63%) 63 patients had grade 2 discopathy, and (35%) 35 patients had grade 3 discopathy, of which (63%) 63 patients were taking painkillers (Table 1).

The mean pain score before intervention in the intervention group was 9.820±0.43 and in the control group was 9.18±1.08, which showed a statistically significant difference between the mean pain scores in the two groups (p=0.0001).

The mean pain score after intervention in the intervention group was 3.42±1.17 and in the control group was 8.36±1.06, which showed a statistically significant difference between the mean pain scores in the two groups (p=0.0001). The results show that the changes in the mean pain score in the intervention group decreased from 9.820 ± 0.43 to 3.42 ± 1.17 and were significant (P=0.0001). Also, in the control group, the mean pain score decreased from 9.18 ± 1.08 to 8.36 ± 1.06 and were significant (P=0.0001). The mean reduction in the pain score in the intervention group was 1.27 ± 6.4 and the mean reduction in the pain score in the control group was 1.40 ± 0.82 units (Table 2). For further investigation, the analysis of covariance test was performed. The results indicate that by controlling the confounding effect of the pain score before the intervention and the degree of discopathy and analgesic consumption, the pain score after the intervention in the intervention group was 0.171 ± 3.374 and in the control group was 0.171 ± 8.406, and the difference in the mean between the two groups was significant (P=0.0001).

The mean comfort intensity before the intervention in the intervention group was 1.16 ± 6.78 and in the control group was 1.14 ± 6.48, which shows that the mean comfort intensity in the two groups was not statistically significant (p=0.171). The mean comfort intensity after the intervention in the intervention group was 9.58 ± 0.6 and in the control group was 1.28 ± 6.12, which shows that the mean comfort intensity after the intervention in the two groups was statistically significant (p=0.0001). The results show that the changes in the mean intensity of comfort in the intervention group increased from 6.78 ± 1.16 to 9.58 ± 0.6 and were significant (P = 0.0001). Also, in the control group, the mean intensity of comfort decreased from 6.48 ± 1.14 to 6.12 ± 1.28 and were significant (P = 0.016). The mean increase in intensity of comfort in the intervention group was 1.19 ± 2.8 and the mean decrease in intensity of comfort in the control group was 1.005 ± 0.36 units (Table 3).

The results indicate that by controlling the confounding effect of the degree of discopathy and analgesic use, the intensity of comfort score after the intervention was 9.598 ± 0.149 in the intervention group and 6.102 ± 0.149 in the control group, and the difference between the two groups was significant (P = 0.0001). Chart 1.

Regarding the ability to perform activities of daily living, which include bathing, cleaning, dressing, walking, and mobility, the chi-square test showed that the intervention in question in the areas of walking ( (chi-square=46.651, p-value=0.0001) ) and mobility (chi-square=32.571, p-value=0.0001) caused a statistically significant difference between the control and experimental groups, but in the areas of bathing, cleaning, dressing, and controlling urination and defecation, Fisher's exact test showed that this difference was not significant (p>0.05).

Discussion:

This study aimed to determine the effect of the knee-back recovery device on the severity of pain, comfort, and ability to perform activities.daily life. The results of the research findings showed that the intervention in question was able to significantly reduce the severity of pain compared to the control group and compared to before the intervention. In a review of the relevant literature, Rajfour et al. (2022) also introduced the effect of using dry needling in addition to an exercise program in reducing pain in patients with discopathy. Although this intervention was able to significantly reduce pain in these patients, it is an invasive method and can have its own complications. Germano (2019) also emphasizes the effect of virtual reality (VR) on the severity of chronic back pain in patients with discopathy. This intervention requires the necessary expertise, equipment, and implementation support.

Edward et al. (2018) state in their research that back pain caused by discopathy increases over time and emphasize the need for future research that can significantly improve this pain. Xu et al. (2020), in their systematic review and meta-analysis, have introduced the effect of yoga on improving short- to medium-term pain and disability in patients with discopathy as effective as other exercises and occupational therapy. Wieland, 2017, in their systematic review, also introduces the effect of yoga on pain in patients with discopathy within 3 to 6 months, but adds that the studies reviewed do not have the minimum required clinical effect size (Wieland, 2017). In the present study, practicing at the end of all sessions with the waist-knee recovery device can have long-term effects on the severity of symptoms of these patients, including their pain, in addition to the short- to medium-term effect.

Regarding the variable of comfort intensity, the research findings showed that the waist-knee recovery device was able to significantly increase comfort in the intervention group compared to the control group, as well as before and after the intervention in the test group. Increasing the intensity of comfort and reducing pain can lead to a decrease in the number of days absent from work and the use of painkillers, which have their own side effects (Chenot, 2017). Therefore, the use of the back-knee recovery device, along with routine treatment and exercises, as a non-invasive treatment, can have a significant impact on the working and daily life of patients with grade 1, 2, and 3 discopathy.

Regarding the ability to perform daily activities, the research findings showed that the use of the back-knee recovery device improved daily activities in the areas of walking and moving, but there was no significant difference between the two groups in the areas of bathing, personal hygiene, urinary and fecal control, and toileting. Germano (2019) also showed in his research that virtual reality intervention can improve patients' physical performance. Although the effect of virtual reality intervention is significant and in line with the advancement of modern technology, it requires specialized equipment and manpower, which is not feasible in all medical and care centers. Zhu et al. (2020) also emphasize the effect of yoga on improving disability in performing daily activities in the short to medium term.

One of the strengths of this study is the innovation and use of the knee-back rehabilitation device as a new method in the adjuvant treatment of patients with grade 1, 2, and 3 discopathy. One of the limitations of this study is the lack of long-term follow-up of patients and the examination of variables that require more time, such as quality of life. It is recommended that patients be followed up for a longer period of time (three to six months) in future studies.

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