Ankle is the most common site for acute musculoskeletal injuries and sprains. Acute ankle trauma is responsible for 10-30% of sports related injuries in young athletes. Ankle sprain is characterized by pain, swelling with or without deformity. According to the Modern science the treatment modalities adopted for the ankle sprain are ankle brace, below knee cast and ankle strap. Inadequate treatment of ankle sprain can lead to chronic problems such as decreased range of motion, pain and joint instability. Acharya Sushruta advocates Alepa with Asthisandhaniya Dravyas for the management of Bhagna. These dravyas when used in the form of Lepa have the properties of Sandhaniya, Shophahara and Vedanasthapaka action. It is a need of hour to bring up new innovative, readily available, patient friendly and time saving techniques which possess the same effect. Hence this study is taken up to bring the Manjistadi Lepa in the modified form as Sandhaniya cast. Such kind of medicated casts weren’t in use till date which makes it unique. This would not only help in immobilization like any other ankle brace or ankle binder, but also reduces localized edema and pain due to its Vedanasthapaka and Shophahara properties and also accelerates the healing

Dhyan Surendranath

K Nikhil Kaushik

KM Sweta

English

Journal of Ayurveda and Integrated Medical Sciences (JAIMS)

                                                     ORIGINAL ARTICLE          July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 1  Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain K Nikhil Kaushik1, KM Sweta2, Dhyan Surendranath4 1Post Graduate Scholar, Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India. 2Professor & HOD, Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India. 3Associate Professor, Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India.                       INTRODUCTION Ankle sprains are the most common of all sports related injuries, accounting for over 25% of cases. This is the most common musculoskeletal injury with an incidence  of 1/10,000/day.[1] In 85 percent of cases,  it Address for correspondence:  Dr. K Nikhil Kaushik Post Graduate Scholar, Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India. E-mail: nikhilmonty63@gmail.com  Submission Date: 13/05/2022 Accepted Date: 18/06/2022 Access this article online Quick Response Code Website: www.jaims.in  DOI: 10.21760/jaims.7.6.1 is due to inversion of supinated plantar flexed foot. In more than 75% of cases, it is the lateral ligament complex that is injured, in particular the anterior talofibular and calcaneofibular ligaments. Medial ligament injuries are usually associated with a fracture or joint injury. Lateral ankle sprain is the most common soft tissue limb injury and < 15 percent actually show a significant fracture. Conventional method of treating an ankle sprain includes various immobilization methods like ankle brace, ankle support etc. Along with regular intake of NSAIDS for symptomatic relief.[2] Other than these features, it doesn’t hold any medicinal property to promote healing of ligamentous injury which is seen in ankle sprain. Thus, Manjistadi Lepa explained by Acharya Sushruta in Bhagna Chikitsa is modified as Sandhaniya cast is an attempt to bring a holistic evidence-based approach for the management of ankle sprain.[3] Such kind of medicated casts weren’t A B S T R A C T  Ankle is the most common site for acute musculoskeletal injuries and sprains. Acute ankle trauma is responsible for 10-30% of sports related injuries in young athletes. Ankle sprain is characterized by pain, swelling with or without deformity. According to the Modern science the treatment modalities adopted for the ankle sprain are ankle brace, below knee cast and ankle strap. Inadequate treatment of ankle sprain can lead to chronic problems such as decreased range of motion, pain and joint instability. Acharya Sushruta advocates Alepa with Asthisandhaniya Dravyas for the management of Bhagna. These dravyas when used in the form of Lepa have the properties of Sandhaniya, Shophahara and Vedanasthapaka action. It is a need of hour to bring up new innovative, readily available, patient friendly and time saving techniques which possess the same effect. Hence this study is taken up to bring the Manjistadi Lepa in the modified form as Sandhaniya cast. Such kind of medicated casts weren’t in use till date which makes it unique. This would not only help in immobilization like any other ankle brace or ankle binder, but also reduces localized edema and pain due to its Vedanasthapaka and Shophahara properties and also accelerates the healing. Key words: Sandhaniya Cast, Ankle Sprain, Ankle Brace, Manjistadi Lepa    K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 2  in use till date which makes it unique. This would not only help in immobilization like any other ankle brace or ankle binder, but also reduces localized edema and pain due to its Vedanasthapaka and Shophahara properties and also accelerates healing. AIM To evaluate the efficacy of Sandhaniya cast in the management of ankle sprain. OBJECTIVES  1. To prepare and standardize Sandhaniya cast. 2. To evaluate the effect of Ankle Brace. 3. To evaluate the efficacy of Sandhaniya cast in ankle sprain 4. To compare the effect of Sandhaniya cast with Ankle Brace in the management of ankle sprain. MATERIALS AND METHODS The study design was open label, randomized controlled clinical study, in this study 30 patients who fulfilled the inclusion criteria were selected from OPD, IPD department of Shalya Tantra. They were divided into two groups Group A (N=15) and Group B (N=15). Group A being the control group and Group B being the trial group. IEC approval was taken before starting the trail, informed written consent of all patients was taken before the operative procedure, and for patients below 21 years of age consent was obtained from parents or guardians. Duration of treatment was till 21 days. Follow up of the patients was carried out on every 3rd day for 21 days in both the groups with total of 6 sittings. Preparation of Sandhaniya cast Sandhaniya cast was prepared under 4 stages: 1. Preparation of Manjistadi Lepa.  2. Application of Manjistadi Lepa over standard cora cloth. 3. Drying of medicated cora cloth. 4. Packing of Sandhaniya cast. Preparation of Sandhaniya Lepa Equipments used - vessels, cloth, stove. Ingredients 1. Manjista Churna - 10g 2. Yastimadhu Churna - 10g  3. Raktachandana Churna - 10g 4. Shali Churna - 10g  5. Shatadhouta Grtha - 10ml  6. Jala - 120ml     K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 3    Procedure The previously mentioned drugs were taken in quantity of 10g each fine powder from a GMP certified pharmaceutical company. The Lepa was prepared by adding 120ml water and heated, till it attains a paste like consistency of total 150grams. Application of Manjistadi Lepa over standard cora cloth Now this Lepa was applied to Cora Cloth having dimensions of 150cm long X 8cm width, Uniformly with equal thickness across the cloth. Drying of medicated cora cloth The cora cloth was then carefully placed in hot air oven at 40° Celsius for a duration of 2 hours. Packing of Sandhaniya cast The dried cast was then removed from hot air oven after 2 hours and preserved in air tight container and were ready to use in this trial.     K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 4  Intervention (Group-B) Sandhaniya cast dipped in warm water (100°F) for 15 seconds just before to the application and its applied around the affected ankle in figure of 8 method of bandaging.   Control Group (Group A) Procedure - Affected ankle is examined and ankle brace was applied   Diagnostic criteria All the classical features of ankle sprain including[4] ▪ Pain ▪ Swelling ▪ Difficulty in walking ▪ X-ray of the affected Ankle joint AP & Lateral view (to rule out fracture). Inclusion criteria ▪ Age - between 21 - 60yrs ▪ Sex - both male and female. ▪ Patients with Grade 1 and grade 2 ankle sprains. Grade 1 Ankle sprain The symptoms tend to be limited to pain and swelling, most patients can walk without crutches, but may not able to jog or jump.[5] Grade 2 Ankle sprain There is usually more significant swelling and bruising caused by bleeding under the skin. Patients usually have pain while walking but can take few steps.[5] Exclusion criteria ▪ Subjects with fracture and dislocation of ankle joint. ▪ Subjects with Grade- 3 Ankle sprain. (Grade 3 Ankle sprain: Ankle is usually quite painful and walking can be difficult, patients may complain of instability or a giving-away sensation in ankle joint)[5] K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 5  ▪ Subjects with previous history of ligament or bony reconstructive surgery to the ankle & foot.  ▪ Subjects presenting with wound over ankle along with sprain will be excluded. Criteria of assessment (subjective & objective) The patients were assessed based on subjective and objective parameters. Subjective parameter - Karlsson scoring scale[6] Objective parameter ▪ Range of motion for Plantar Flexion. ▪ Range of motion for Dorsi Flexion. ▪ Range of movement for Inversion. ▪ Range of movement for Eversion. ▪ Ankle girth OBSERVATIONS AND RESULTS Observation during preparation of Sandhaniya cast ▪ Shali Churna was difficult to mix in Lepa forming lumps. ▪ Red color of the Lepa and pleasant odour of the preparation were appreciated. ▪ Shatadhouta Grtha gives Lepa a smoother consistency. ▪ Application of Lepa over the cora cloth was difficult to spread uniformly all across. ▪ The outer borders of cora cloth if not stitched leads to loose threads all across the bandage. ▪ Wet cast immediately after the application of Lepa needs utmost care to avoid spillage of Lepa and sticking to itself ▪ Placing the wet bandage in hot air over was found difficult. ▪ No powdering was noted after the cast was dried. ▪ Packing the cast without proper drying leads to formation of fungus due to left over moisture. ▪ Air tight containers had served better in packaging compared to the normal packing. ▪ Greater than 2 months of storage led to powdering of the Lepa from cast and change in odour. Observations during intervention Group - A ▪ Ankle brace was easy to apply. ▪ It was non-irritant. ▪ Facilitated easy and painless removal.  Group - B ▪ Application of Sandhaniya cast was easy. ▪ Negligible amount of wastage was noted when the dried bandage was dipped before application. ▪ Cast should be left immobilized for at least 3 hours for setting period. ▪ Cast was easy to remove without much manipulation to the ankle. ▪ Sandhaniya cast caused mild itching and irritation after drying. ▪ Colour of Lepa i.e., red colour was left over ankle after removal of cast. RESULTS Table 1: Between the group comparison (BT & AT) for Anterior drawer test.   Change in Anterior drawer test between BT and AT Group A Group B Total  Mann Whitney U test N % N % N % z p No change 2 13.3 0 0 2 6.7 1.439 0.150 Improved  13 86.7 15 100 28 93.3 Total 15 100 15 100 30 100   Table 2: Between the group comparison (BT & AT) for Inversion talar tilt.  Change in Inversion talar tilt test between BT and AT Group A Group B Total  Mann Whitney U test N % N % N % z p No change 0 0 0 0 0 0 K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 6  Improved  15 100 15 100 30 100 0.000 1.000 Total 15 100 15 100 30 100   Table 3: Between the group comparison (BT & AT) for Karlsson scoring scale  Karlsson scoring scale Group A Group B Total  Mann Whitney U test N % N % N % z p BT Poor 15 100 15 100 30 100 0.000 1.000 AT Excellent 5 33.3 10 66.7 15 50 1.795 0.073 Good 10 66.7 5 33.3 15 50 Table 4: Between the group comparison (BT & AT) for Ankle girth. Ankle girth (cm) Group A Group B Unpaired t test Mean Rank SD Mean Rank SD t p BT  25.5 1.4 26.3 3.2 0.963 0.344 AT 23.9 1.3 24.4 3.2 0.643 0.526 Change in Ankle girth 1.6 0.6 1.9 0.7 1.245 0.224 There was a significant difference before and after the treatment between the groups with high clinical efficacy seen in Group B compared to Group A in respect to subjective and objective parameters. Pain and swelling reduced in Group B by 2nd sitting whereas in Group A it was delayed upto 4th sitting. DISCUSSION Rakta Prasadaka, Vatapitta Shamaka, Twak prasadaka, Shotahara, Shoolahara & Sandhaneeya properties of Sandhaniya cast is assumed to target acute nature and associated attributes like pain, swelling, reduced range of movements of ankle joint due to ligamentous injury, localized oedema and soft tissue injury of ankle.  The standardized form of Sandhaniya cast was sufficient enough to produce the therapeutic effect. Furthermore, the formulation in the form of Sandhaniya cast is apt for the ankle injury with grade-1 to grade-2 ankle sprains, providing adequate immobilization amplifying healing of injured ligaments. Along with Glycyrretic acid of Yastimadhu, extract of Manjista and decoction of Raktachandana proved to have anti-inflammatory action reducing the localised oedema, pain and discomfort during ankle sprain.  LIMITATIONS For Assessment of subjective & objective criteria for total 6 sittings across 21 days, subjects faced difficulty to visit to OPD frequently with ankle sprain. Subjects faced difficulty to avoid weight bearing over affected ankle joint during the course of treatment as ankle is important weight bearing joint. Control Group  Before the treatment K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 7   Ankle brace  After the treatment Trail Group  Before the treatment  Sandhaniya cast  After the treatment CONCLUSION Sandhaniya cast not just seemed to exhibit the qualities of an ideal immobilization method, but also appeared to manifest its therapeutic effects of the formulation impregnated in it in a standardized dose. Sandhaniya cast could be a better alternative for ankle brace in the management of ankle sprain.  REFERENCES 1. Maheshwari J, Vikram A Mhaskar. Essential Orthopedics.5th ed. New Delhi: J. Maheshwari; 2015. p.162. K Nikhil Kaushik et al. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain ISSN: 2456-3110                                                     ORIGINAL ARTICLE July 2022  Journal of Ayurveda and Integrated Medical Sciences | July 2022 | Vol. 7 | Issue 6 8  2. John Ebnezar. Text Book of Orthopedics. 4th ed. New Delhi: JAYPEE Brothers Medical Publishers(P)Ltd; 2010. p.278-79. 3. YT Acharya, editor, Sushruta Samhita of Sushruta with Nibandha Sangraha commentary of Sri Dalhanacharya and Nyachandrika Panjika of Gayadasa. Nidana sthana.Chapter 3, Verse 7. Reprint ed. Chaukhamba Orientalia Varanasi;2002; p.213. 4. Rajesh Malhotra, Surya Bhan. Text book of Orthopedics.New Delhi, CBS Publishers and Distributors; 2004. p.269. 5. David J. Magee. Orthopedic Physical Assessment.4thed. Pennsylvania, Elsevier Science; 2002. p.777 6. Karlsson J, Peterson L.Evaluation of ankle of ankle joint function:the use of scoring scale.LGUK[Internet].1991 January[cited 2109 December 20];1(15);15-16.     *******************************  How to cite this article: K Nikhil Kaushik, KM Sweta, Dhyan Surendranath. Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain. J Ayurveda Integr Med Sci 2022;6:1-8. http://dx.doi.org/10.21760/jaims.7.6.1  Source of Support: Nil, Conflict of Interest: None declared. Copyright © 2022 The Author(s); Published by Maharshi Charaka Ayurveda Organization, Vijayapur (Regd). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc-sa/4.0), which permits unrestricted use, distribution, and perform the work and make derivative works based on it only for non-commercial purposes, provided the original work is properly cited.   

Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain

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Clinical trial to evaluate the efficacy of Sandhaniya Cast in Ankle Sprain

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