Therapeutic Electro Soft Tissue Mobilizer

Abstract: 7. ABSTRACT OF TNE INVENTION (objective along with complete specification on separate page) INTODUCTION: This study focuses on developing and validating a handheld device that combines electrotherapy with advanced ergonomics to mobilize soft tissues, minimize the soft tissue pain, and improve joint range of motion (JROM). Soft tissues, such as muscles and ligaments, play a crucial role in human movement, but various factors can compromise their health and hinder activities of daily living. Physiotherapists commonly use techniques like myofascial release and massage, but these can lead to overuse injuries in therapists. By integrating electrotherapy into a handheld device, this study aims to enhance therapeutic interventions while minimizing the risk of injuries. The device's efficacy in mobilizing soft tissues, improving JROM, and reducing pain will be evaluated, contributing to advancements in the field of physiotherapy. OBJECTIVE: 1. The primary objective of this research is to design a handheld device specifically tailored to mobilize muscles effectively. The device will be ergonomically designed to provide optimal comfort and usability during therapeutic interventions. 2. The device's efficiency in managing muscle pain and improving Joint Range of Motion (JROM) will be thoroughly tested using scientific methods and evidence. The study will include controlled experiments and clinical trials to assess the device's effectiveness in alleviating muscle pain and enhancing JROM in individuals with various conditions. 3. The applicability of the device will be assessed by conducting tests on both healthy individuals for calf muscles (phase II) and patients (Phase III) with upper trepizeous. This comprehensive evaluation will provide valuable insights into the device's versatility and its potential benefits across a wide range of clinical populations. Overall, this research aims to contribute to the development of an innovative handheld device that can effectively mobilize muscles, alleviate pain, and improve JROM. The scientific testing and evaluation will provide essential evidence to support the device's applicability and efficiency in both healthy individuals and patients with musculoskeletal conditions. METHOD: The Multiphasic study has been divided into three phases. • Phase I - Developing the Electro Mobilizer Device • Phase II - validating the Therapeutic Electro Soft Tissue Mobilizer with IASTM for soft tissue Mobilization and improving the JROM for ankle dorsiflexion in normal individuals. The study has obtained approval from the Ethics Committee approved by CDSCO and has CTRI number. • Phase III: testing devise for patient’s populations. BACKGROUND: Movement is a Life. Human biological systems are responsible for every successful movement human make, however, soft tissues such as muscles, ligaments, tendons, and fascia plays a key role in every healthy movement of Activities of Daily Living (ADLs) including walking, climbing, running, bathing, grooming, etc. Several factors are further responsible to compromise an individual's movements, including fitness, training, aging, myofascial friction, injuries, pain, spasms, diseases, and disorders. Healthy soft tissues are essential to maintain joint range of motion (JROM) and to produce healthy movements. Any malfunction or derangement in the soft tissues can compromise human movements. To correct such challenges advancements in therapeutic interventions are needed for physiotherapists especially myofascial release, massage, TENS, etc... These interventions are broadly distributed among hands-on skills (myofascial release, massage) and electrotherapeutic (TENS) approaches in the field of physiotherapy. Even, those physiotherapists who are practicing therapeutic intervention observe overuse injuries to their fingers. hands and wrists to compromise the quality of therapeutic intervention. There are several assistive devices available for therapists to assist as well as mobilize and maintain the properties of the soft tissues to improve compromised joint range of Motion (JROM), pain, and spasm. Since the integration of electrotherapy with the advancement of ergonomics in device development will have added value to assisting therapists on one hand and maintaining the soft tissue properties on the other. Objectives: The aim of the study is to develop and validate a handheld device to mobilize soft tissues and improve JROM. To observe the efficacy of the device in the management of pain in the soft tissue by integrating electrotherapy. METHODOLOGY: The multiphasic study has been divided into three phases. Phase I - Developing the Electro mobilizer Device, Phase II - validating the Therapeutic Electro Soft Tissue Mobilizer with IASTM for soft tissue mobilisation and improving the JROM for ankle dorsiflexion in normal individuals. The study has obtained approval from the Ethics Committee approved by CDSCO and has CTRI number. Phase I: Designing Therapeutic Electro Soft Tissue Mobilizer. The size and shape of the handheld device was designed as per the measurement of the human thumb as well as first web space. In this phase, the surgical Stainless Steel (SS 316 L) used for the body of the device and attached handle made of aluminium covered by insulated nylon material. The surface of the device is smooth and bevelled so that it may glide over the soft tissues surface easily. Bottom part of the handle having space to insert the probe comes from the Electrotherapeutic Device - TENS. Method and Result: to design the size and shape of the main body. ? Left Side curvature of the Device: 30 subjects with age between 18 to 25 years have taken to measure the curvature of the human dominant 8cm as mentioned in PICTURE 3. ? Right Side curvature of the Device: To find out the circumference of soft tissues, especially those large and small muscles such as calf muscle (Soleus and Gastrocnemius), and brachioradialis respectively were assessed with muscles girth circumference and mean found 6.25 cm as per the PICTURE 3. ? Top Side: The curvature was derived from the length of left side of the device and is curved, which is used to treat the flat muscles as per shown in PICTURE 1.) ? Bottom Part: The handle is made of aluminium, which is a good conductor of electricity. However, to prevent the risk of electric shock the handle is covered by nylon insulating materials. The bottom connected handle described appears to be designed with safety in mind, using materials that help to prevent the risk of electric shock during use. The circumference of the handle was kept 9 cm and length of the handle 16 cm as mentioned in PROTOTYPE 4. ? Insertional Point: bottom of the handle having a socket (male) to attach the pin (female) wire input of the TENS machine. It allows the device to transfer the electrical stimulation via main steel body and closing the loop with ground electrode attached with the person’s skin near to the soft tissues as per the ROTOTYPE 4. Pic 3 Designing the device. PICTURE 4 - PROTOTYPE 1 PICTURE 5-PROTOTYPE 2 PICTURE 6 -PROTOTYPE 3 PICTURE 7-PROTOTYPE 4 Phase II: Validating the device on a normal population to identify its efficacy to improve JROM as compared to available IASTM device. In this phase 30 healthy individuals have been distributed into 2 groups, control group received instrument assisted soft tissue mobilization (IASTM) and experimental group received Therapeutic Electro Soft Tissue Mobilizer for mobilising the calf Muscles with the electron current (TENS). Then pre and post changes in ankle joint range of motion for ankle dorsiflexion was assessed among normal healthy individuals. Both the therapeutic approaches were given for 4 minutes in a single session, contralateral limb for a person and pre-post changes were observed at ankle JROM (dorsiflexion) by goniometry. Statistical analysis: SPSS version 22 has been used for statistical analysis. Normality check followed by paired sample T test was used to analyze the changes within the group and between the groups. Validity was checked with correlation coefficient for mean difference of changes in JROM for ISTM with Therapeutic Electro Soft Tissue Mobilizer. RESULT AND DISCUSSION: Data analysis observes that both the groups showing significant improvement in the Ankle JROM and high correlation. The level of significance and high correlation suggests the Therapeutic Electro Soft Tissue Mobilizer has an efficient effect as compared to IASTM. Moreover, the electro therapeutic approach will be much appreciated if the study is done indivisible with the pain or malfunctioning of calf soft tissues. The improvement in JROM (control and Experimental) was detected suggesting micro massage, tactile stimulation, and even electric stimulation. The mean pre-NPRS score was 6.66 with a standard deviation of .844, while the mean post-NPRS score was 3.56 with a standard deviation of 1.155. The t-value was 20.097, and the p-value was 0.000, indicating that the difference between the two scores is statistically significant. Therefore, it can be inferred that the intervention or treatment given to the patients was effective in reducing their cervical pain as measured by the NPRS scores. The mean post-JROM score increased significantly to 27.53, which indicates a significant improvement in the patients' range of motion. Table 1 Paired sample t test for finding the changes between pre and post values of JROM when treatment is given by IASTM in Control Group JROM between control / experimental groups Pre JROM (mean) Post JROM (mean) MEAN dif. SD T Value P Value Pre and Post changes JROM IN Control group 20.8 26.6 -5.76 2.38 -13.227 .000 Pre and Post changes JROM in Experimental group 18.5 23.2 -4.73 2.80 -9.249 .000 Interpretation: The mean JROM measurement was higher in the control group than the experimental group both before and after the intervention. ? Both groups showed a decrease in JROM after the intervention, as indicated by the negative mean difference values. ? The standard deviation in the experimental group was slightly higher than in the control group, indicating greater variability in the data. ? The t-values for both groups were significant and negative, indicating a statistically significant difference in mean JROM before and after the intervention. ? The p-values for both groups were less than 0.05, indicating a statistically significant difference in mean JROM before and after the intervention. ? The correlation coefficient is positive but weak, indicating a small positive linear relationship between the pre- and post-intervention JROM values in both groups. ? It seems that the intervention had a negative effect on JROM in both groups, as indicated by the negative mean difference values and the statistically significant t and p values. However, further analysis is needed to determine the nature of the intervention and its impact on JROM in different groups. Effective in improving joint range of motion. Our result shows there is significant improvement in increasing the ankle dorsiflexion. Phase III In this phase, it consists of the single group and the intervention is taken to see the changes in NPRS score for the pain reduction and JROM in cervical side flexion. All the participants will receive a session of an electromobilizer device. Pre and Post data will be collected. Both the therapeutic approaches were given for 4 minutes in a single session, contra lateral limb for a person and pre-post changes were observed at cervical JROM by goniometry and pain by NPRS score. TABLE 2 PAIRED SAMPLES TESTS SHOWS OF CHANGES IN NPRS IN UPPER TRAPEZIUS MUSCLE NPRS MEAN SD T VALUE P VALUE RESULT PRE NPRS-SCORE 6.66 .844 20.097 .000 Significant POST NPRS SCORE 3.56 1.155 Interpretation: Based on the analysis of Table 2, it can be concluded that there is a significant difference between the pre and post NPRS scores in cervical patients. The mean pre-NPRS score was 6.66 with a standard deviation of .844, while the mean post-NPRS score was 3.56 with a standard deviation of 1.155. The t-value was 20.097, and the p-value was .000, indicating that the difference between the two scores is statistically significant. Therefore, it can be inferred that the intervention or treatment given to the patients was effective in reducing their cervical pain as measured by the NPRS scores. TABLE 3 PAIRED SAMPLES TESTS SHOWS OF CHANGES IN JROM IN CERVICAL SIDE FLEXION JROM MEAN SD T VALUE P VALUE RESULT PRE JROM-SCORE 23.63 3.69 -18.491 .000 Significant POST JROM SCORE 27.53 3.40 Interpretation: The analysis of Table 3 shows a significant improvement in the post-treatment JROM scores of cervical patients as compared to the pre-treatment JROM scores. The mean pre-JROM score was 23.63, which indicates that the patients had restricted range of motion before the treatment. The standard deviation of 3.69 shows that the range of motion varied across patients before the intervention. After the treatment, the mean post-JROM score increased significantly to 27.53, which indicates a significant improvement in the patients' range of motion. The absence of p-value suggests that the difference between the pre- and post-treatment JROM scores is statistically significant. Concluding - RESULT AND DISCUSSION: Data analysis observes that both the groups showing significant improvement in the Ankle JROM and high correlation. The level of significance and high correlation suggests the Therapeutic Electro Soft Tissue Mobilizer has an efficient effect as compared to IASTM. Moreover, the electro therapeutic approach will be much appreciated if the study is done indivisible with the pain or malfunctioning of calf soft tissues. The improvement in JROM (control and Experimental) was detected suggesting micro massage, tactile stimulation, and even electric stimulation. The mean pre-NPRS score was 6.66 with a standard deviation of .844, while the mean post-NPRS score was 3.56 with a standard deviation of 1.155. The t-value was 20.097, and the p-value was 0.000, indicating that the difference between the two scores is statistically significant. Therefore, it can be inferred that the intervention or treatment given to the patients was effective in reducing their cervical pain as measured by the NPRS scores. the mean post-JROM score increased significantly to 27.53, which indicates a significant improvement in the patients' range of motion. CONCLUSION. The therapeutic electro mobilizer device has proven to be effective in improving joint range of motion (JROM) and reducing muscular pain, making it a valuable addition to professional physiotherapy practice. However, while its benefits have been established for joint ROM, its potential for treating soft tissues such as quadriceps, deltoid, hamstring, and smaller groups of muscles and ligaments requires further investigation. To determine its overall therapeutic value in physiotherapy, it is essential to assess the device's performance in treating various soft tissue areas separately The inventive features of the Electrotherapeutic Soft Tissue Mobilization - Device are designed to provide high-quality scientific and clinical benefits: • Ergonomic Design Informed by Scientific Evidence: The device incorporates an ergonomic size and shape, meticulously designed based on scientific evidence related to the surface area of soft tissues, thumb, and first web space. This ensures optimal contact and effective treatment delivery to the targeted areas, supported by research in anatomical considerations. • Integration of Muscle Stimulator/TENS for Enhanced Therapeutic Value: By integrating a Muscle Stimulator or Transcutaneous Electrical Stimulation (TENS) functionality, the device enhances its therapeutic value. This advanced feature delivers controlled electrical stimulation to the soft tissues, based on clinical evidence that demonstrates its efficacy in promoting pain relief, reducing muscle spasms, and facilitating tissue healing. • Customizable Settings for Personalized Treatment: The device offers customizable settings that can be tailored to individual patient needs. This allows physiotherapists to adjust the intensity and frequency of the electrical stimulation, ensuring personalized treatment plans that align with the patient's condition, tolerance, and desired outcomes. Such individualized approaches have been shown to yield superior clinical results. • Portable and Handheld Convenience for Clinical Versatility: Designed as a portable and handheld device, it provides convenience and versatility in various clinical settings. Its compact form factor allows physiotherapists to easily maneuver and apply the therapy to different body regions, ensuring optimal treatment delivery and patient comfort. • User-Friendly Interface Facilitating Efficient Operation: The device features a user-friendly interface that promotes efficient operation by healthcare professionals. Clear instructions, intuitive controls, and a well-designed interface streamline the treatment process, allowing physiotherapists to focus on delivering high-quality care and maximizing patient outcomes. • By incorporating these high-quality scientific and clinical features, the IASTM Electrotherapeutic Soft Tissue Mobilization Device exemplifies an innovative solution in the field of physiotherapy. Its evidence-based design, integration of advanced technologies, customizable settings, portability, and user-friendly interface collectively contribute to improved patient experiences and clinical outcomes. Benefits/Advantages of the Electrotherapeutic Soft Tissue Mobilization Device: 1. Enhanced Therapeutic Value: The device's ergonomic design and integration of Muscle Electrical Stimulation/TENS provide a comprehensive approach to maintaining the properties of soft tissues. By combining soft tissue mobilization with targeted electrical stimulation, the device promotes efficient healing, pain relief, and improved joint range of motion. 2. Effective Pain and Spasm Management: Physiotherapists can utilize the device to effectively manage muscular pain and spasms. The precise control and adjustable settings allow for targeted soft tissue mobilization and stimulation, providing relief and relaxation to affected muscles. 3. Minimized Risk of Overuse Injuries: The ergonomic advantages of the device reduce the risk of overuse-related injuries to the thumbs, fingers, and wrists of physiotherapists. Its design ensures optimal handling and usability, allowing therapists to deliver effective treatment without compromising their own well-being. 4. Versatile Application: The device can be utilized in various clinical settings and for a wide range of soft tissue conditions. Its adaptability and customizable features make it suitable for addressing different patient needs and treatment goals. 5. Improved Patient Experience: The combination of soft tissue mobilization and Muscle Electrical Stimulation/TENS offered by the device leads to enhanced patient outcomes. Patients benefit from reduced pain, improved muscle function, and increased overall satisfaction with their physiotherapy treatment. 6. Evidence-Based Approach: The device's development and integration are supported by scientific evidence and research studies in the field of physiotherapy. This ensures that the device's therapeutic interventions are grounded in established principles and techniques. 7. By highlighting these benefits and advantages, it is evident that the IASTM Electrotherapeutic Soft Tissue Mobilization Device offers a valuable and innovative solution for physiotherapists in effectively managing soft tissue conditions and promoting optimal patient outcomes. Available information related to proposed research work. There are various non-invasive therapeutic tools and techniques available to manage soft tissue pain and spasm and improve joint range of motion. Hands on skills such as manual therapy, myofascial release play a crucial role in early recovery from soft tissue injuries. However, there are several devices available in the market needs enhancement with its size and shape as per the surface areas of various soft tissues and even integrating the electrotherapy for expediting the recovery from soft tissue injuries. List of patent or non-patent literature searched/reviewed 1. Kim, Young Kyun, et al. "Effect of Transcutaneous Electrical Nerve stimulation as an instrument-assisted soft tissue mobilization combined treatment on chronic low back pain: A randomized control trial." Journal of Back and Musculoskeletal Rehabilitation, vol. 31, 2021, pp. 1-9. doi:10.3233/BMR 200369. 2. Abdelhamid, Mohamed N.H., et al. "Trigger point release versus IASTM on upper trapezius trigger point in mechanical neck pain: A randomized clinical trial." MEd. J. Cairo Univ., vol. 88, no. 5, 2020, pp. 2073-2079. www.medicaljournalofcairouniversity.net. 3. Motimath, Basavaraj, et al. "Immediate effect of instrument-assisted soft tissue mobilization (IASTM) With M2T blade technique in trapezitis: An experimental study." International Journal of Applied Research, vol. 3, no. 5, 2017, pp. 527-529. 4. Basu, Soumik, et al. "Comparative Study of Instrument Assisted Soft Tissue Mobilization Vs ischemic compression in Myofascial trigger points on upper Trapezius muscle in professional Badminton player: An experimental study." Indian Journal of Physiotherapy and Occupational Therapy, vol. 14, no. 1, 2020, pp. 1-10. 5. Kim, Jooyoung, et al. "Therapeutic effectiveness of IASTM for soft tissue injury: Mechanism and practical application." Journal of Exercise Rehabilitation, vol. 13, no. 1, 2017, pp. 12-22. 6. Seffrin, Cristina B., et al. "Instrument assisted soft tissue mobilization: A systematic review and effect-size analysis." Journal of Athletic Training, vol. 54, no. 7, 2019, pp. 738-753. 7. Dharmendrasinh, Mahida Payal. "Effectiveness of Instrument-assisted soft tissue mobilization on pain and functional disability in subjects with Patellofemoral pain syndrome." International Journal of Recent Scientific Research, vol. 11, 2020, pp. 40885-40888.

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