Efficacy of integrated protocol in the management of ankle sprain in sports injuries - A randomized controlled clinical trial

Abstract

Background

Among athletes, ankle sprains are the most frequent injury, with an prevalence of 12.62% of all injuries. Sports injuries can be prevented and treated more effectively when complementary and alternative medicine is used. In Ayurveda ankle joint injuries are correlated with Gulpha (ankle) marmabhighata (injury to important point of concern for health) and management is done accordingly. Integrated approach using Ayurveda and Physiotherapy protocol is the need of hour to produce evidence-based results.

Objectives

To evaluate the efficacy of the integrated management protocol of ankle sprain in sports injuries.

Materials and methods

A total of 30 patients with ankle sprains were recruited after satisfying the inclusion and exclusion criteria. The procedures (Integrated and Standard) were performed after obtaining informed consent, and the participants were divided into two groups, i.e., the treatment group (integrated approach) and the control group (standard approach). Parameters like pain, swelling, temperature, tenderness, range of motion and manual muscle testing were all measured at baseline and at various time points (6^th, 11^th, and 18^th day) throughout the study.

Statistical analysis

The data was analysed with the Mann-Whitney U test, Wilcoxon matched pairs test, independent 't’ test, and dependent ‘t'test.

Results

The treatment group has shown significantly better results (within and between groups) than the control group in relation to all the parameters like pain, tenderness, temperature, swelling, range of motion, and manual muscle testing.

Conclusion

An integrated approach using Ayurveda and physiotherapy was found to be more effective than the standard approach in the management of ankle sprains.

1. Introduction

Among all sports-related injuries, acute ankle sprains account for 16%–40% and are commonly found in athletes in basketball and soccer [1]. It is more common in children, women, and athletes who participate in indoor and court sports [2]. Lateral ankle sprains are the most common type of presentation and occur twice as often as other types of ankle sprains affecting the anterior talofibular ligament [3]. In Ayurveda classics, direct references to sports injuries are not available, but they can be correlated to several conditions like Marmaghata (damage to vital points), Sadyovrana (traumatic wound), and Bhagna (fractures) [4]. Gulpha marma (ankle vital point) is one among Rujakara marma (vital point injury leading to pain) and Sandhi marma (vital point). Injury to this marma (vital point) causes ruja (pain), stabdha padata (foot stiffness), and khanjata (limping) [4,5].Rest, ice application, compression, elevation, analgesic and anti-inflammatory medications, bracing and immobilization, early weight-bearing and walking assistance, foot orthoses, manual therapy, exercise therapy, and electrophysical modalities are all recommended for the management of acute sports injuries [6]. According to studies, at least 73% of people who have an ankle sprain acquire persistent symptoms such as discomfort, giving way, loss of proprioception, and neuromuscular control, resulting into chronic ankle instability [7]. Nonoperative treatment is often successful in achieving satisfactory outcomes. Proper diagnosis and treatment are important at the time of the initial evaluation to mitigate the risks of recurrent instability [8]. The cost of treating such injuries is very high, which in turn has a significant impact on the athlete's training and return to play [9].Despite its common occurrence, high cost, and long-term morbidity, the optimal technique to treat acute ankle sprains is still controversial [10].

Scattered references are available regarding the treatment principle of marmabhigata injury to vital points), which includes both internal and external remedies along with healing time in different age groups, which guides to the development of protocols for sports injury management. Ayurveda classics explain the immobilization of affected parts with various casts prepared from the stem barks of Arjuna (Terminalia arjuna), Madhuka (Madhuka longifolia), etc.; Grushti ksheera (colostrum milk) consumption; abhyanga (massage); Swedana (fomentation treatment); and the application of lepa (medicated paste); pichu (oil cotton Swab) in the management of injuries [11]. These treatments are commonly used by clinicians, either single or multiple, in the management of common sports injuries. Specific treatment protocols using these procedures for injury management are not widely practiced, so the development of protocols based on Ayurveda and modern scientific principles may bridge the gap.

The patients with chronic musculoskeletal diseases seek one or other form of treatment from complementary and alternative medicine (CAM) to get rid of pain and dysfunction [12]. Application of CAM in the field of sports helps in prevention of sports injuries, improve the recovery of the injured tissue, and increases fatigue recovery for athletes [13]. Hence the protocol was designed with integration of physiotherapy and Ayurveda procedures, which was tested in the present study to assess the efficacy of integrated care and standard care in the treatment of ankle sprains.

2. Materials and Methods

2.1. Preparation and procurement of raw materials and formulations

Marmani Gutika pill, Murrivenna taila and Balaarishta were procured from a GMP certified Kerala Ayurvedic pharmacy. Raw ingredients for Manjishtadi churna lepa were obtained from KLE GMP certified Ayurveda pharmacy in Khasbag, Belagavi. The raw pharmaceuticals were authenticated and the completed product was analysed at KLE Shri BMK Ayurveda Mahavidyalaya's AYUSH-certified drug testing central research centre.

2.2. Diagnostic criteria

The patient with history of fall during sports within 48 hours with following sign and symptoms like pain, swelling, tenderness at ankle joint region and restricted joint movements were considered. The following tests like Anterior drawer test, squeeze test, talar tilt test, Thompson Test were performed to rule out ligament injuries, bone fractures and dislocations [14].

2.3. Participant selection

2.3.1. Inclusion criteria

The research comprised individuals with a diagnosed ankle sprain, ranging in age from 18 to 40 years, who complained of pain, oedema, discomfort, and limited joint movements.

2.3.2. Exclusion criteria

The patients diagnosed with ankle joint fractures with partial or total displacement, as well as joint deformity. Diagnosed patients of Tuberculosis, Bleeding disorders, Diabetes mellitus, and malignant wounds were excluded from the study.

2.3.3. Data collection

Irrespective of sex, caste and socio-economic status, a total of 30 participants (15 in each group) of diagnosed ankle sprain due to involvement in sports, who visited the OPD and IPD of Shalyatantra department, KLE Ayurveda Hospital and Medical Research Centre in Belagavi, were recruited for the study. The study was a randomized controlled clinical trial and methods were not modified after the initiation of the study. Until the study's completion, there was adherence to the plan. The study was conducted as a part of PG dissertation work, due to time constraint, availability of patients, financial issues etc., the participants were restricted to 30 for drawing the conclusions. The participants were randomly divided into two different groups by computer-generated random number software and they were allocated to control and treatment groups in a 1:1 ratio. The central case registration numbers were allotted to the participants as per the randomisation chart.The participants were screened as per the inclusion and exclusion criteria by the authors and treatment to the recruited patients were allotted accordingly. The CONSORT flow diagram of the study is provided in figure no 1.(See Fig. 1)

Fig. 1.

– CONSORT flow diagram of the study.

2.4. Treatment protocol

The treatment protocol was designed according the principles of Ayurveda (Bhagna, Sadyovrana and Marmabhighata) and adopting the contemporary sciences treatment principles (Table 1) (Fig. 2).

Table 1.

Stages of treatment with procedures

Treatment Group
No	Stage-I (1–5 Days) Immediate Rehabilitation (Control of Pain and Inflammation)	Stage-II (6–10 Days) Intermediate Rehabilitation (Repair and Regeneration of Tissue and Improve Muscle Performance)	Stage-III (11–17 Days) Advanced Rehabilitation (Muscle Strengthening and Restoring ROM)
1.	Local application of manjisthadilepa twice daily until it gets dry or 30 min.	Murivenna taila pichu application at affected site twice daily followed by bandhana for 24 h.	Sthanika abhyanga with murivenna taila followed by shashtika shali pinda sweda once daily.
2.	Immobilization of affected part with bandhana as required (elastic crepe bandage, splint application). Isometric exercises to improve tone of muscles	a) Transcutaneous electric nerve stimulation (TENS) - 10 min daily once b) Active/Passive exercises and active assisted exercises∗.	a) Interferential therapy – 20 min in daily once b) Ultrasound therapy – 5 min daily once c) Muscle strengthening exercises∗
3.	Internal medication: a) Marmanigutika 250 mg 1tablet thrice a day after food	Internal medication: a) Marmanigutika 250 mg 1tablet thrice a day after food	Internal medication a) Balaarishta 20 ml twice daily after food
Control group
1.	REST Foot end elevation Cryotherapy – Ice application for 20 min	Transcutaneous electric nerve stimulation (TENS) - 10 min daily once	a) Interferential therapy – 20 min daily once b) Ultrasound therapy - 5 min daily once
2.	Compression with affected part with elastic crepe bandage. Isometric exercises	a) Active/Passive exercises∗ and b) active assisted exercises∗. c) Bandaging	c) Muscle strengthening exercises∗

∗ Exercises – Static exercises 1) Toe curls and Toe abduction (3 sets x 10 to 12 repetitions).

2) Single leg standing - (3 sets x 15–30 s) (starting with support.

Progressing to without support).

Dynamic exercises – 1) Heel Raises and Toe raises (3 sets x 10 to 15 repetitions).

2) Lunges (Forward, backward and Side) (3 sets x 10 repetitions).

Fig. 2.

Treatment protocol for ankle sprain management.

The work was primarily carried out at KAHER’S Shri B M Kankanawadi Ayurveda Hospital and Research Centre Shahapur, Belagavi, Karnataka.

2.5. Intervention

The informed consent was taken after explaining the study design. The complete duration of treatment was 17 days and patient were divided into two groups i.e. the treatment group (integrated approach) and the control group (standard approach). Approval of the study was taken from Institutional Ethics Committee dated August 21, 2020 with Protocol Id BMK/19/PG/ST/04. CTRI Registration Number CTRI/2020/08/027310. Data was collected from June 2021 to April 2022. Patients were requested/advised to follow the treatment protocol and guided to report if any adverse effects occur during the study period. The treatments for physiotherapy were carried out under the supervision of a certified physiotherapist from our institute, KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi.

2.6. Criteria for assessment

2.6.1. Primary outcomes

The primary outcome measures were pain, swelling, range of motions and temperature.

• 1.The visual analogue scale and the verbal descriptive scale were used to assess ankle joint pain. The VAS scale has a number ranging from 0 to 10, with 0 representing "no pain" and 10 representing "maximal pain". The VDS scale has a number range of 0–10, with 0 representing "no pain" and 10 representing "worst pain" [7].
• 2.Ankle swelling was measured with a tape measure using the "figure of eight" method, with readings recorded in centimetres. Bony landmarks around the ankle are used to create the figure-of-eight method. The anterior talofibular ligament, anterior tibiofibular ligament, and calcaneofibular ligament are frequently the sites of ankle sprain swelling. A more precise clinical evaluation of ankle swelling may be obtained with the figure-of-eight method because the tape measure spans all of these anatomical areas [4].
• 3.Active Range of motion (ROM): Using a standard hand-held half circle goniometer, the range of motion for active dorsiflexion, plantarflexion, inversion, and eversion was measured while the subject was lying supine. The fulcrum of the goniometer was positioned over the lateral aspect of the lateral malleolus, the distal arm was positioned parallel to the lateral aspect of the fifth metatarsal, and the proximal arm was aligned with the lateral midline of the fibula to measure dorsiflexion and plantarflexion. The goniometer's proximal arm was positioned parallel to the lower leg's anterior midline for inversion and eversion, its distal arm was aligned with the plantar aspect of the first to fifth metatarsal heads, and its fulcrum was situated over the lateral aspect of the fifth metatarsal heal [7]. The steel goniometer was purchased from online sources (Surgigraft goniometer, 2019 model)
• 4.Temperature - The temperature at the ankle joint was measured using an digital infrared thermometer which was placed midway between two malleoli and recorded in Fahrenheit [4]. The thermometer was purchased from online sources (Intex Thermosafe Non-contact FDA Approved Digital Infrared Thermometer, 2020 model)

2.6.2. Secondary outcomes

Tenderness and Manual muscle testing were considered as secondary outcomes. Tenderness was graded using the modified Cipriano scale, with 1 corresponding to tenderness with "no physical response" and 4 corresponding to "patient refusal to palpation due to pain" [4]. Manual muscle testing was graded (modified Cipriano scale) on a scale of 0–5, with 0 representing no contraction and 5 representing full range of motion against gravity with maximum resistance [4].

2.7. Data analysis

Analysis was preformed by using SPSS version 20.0 and p < 0.05 was considered as statistically significant. Categorical variables were summarized using frequency and percentage. Quantitative variables were summarized using mean and SD if data follows normality assumption or else using Median and IQR [Q1, Q3]. Shapiro test was used to check the normality of the data and if followed then for paired data dependent ‘t’ test was applied and for unpaired independent sample ‘t’ test. The data which is not normally distributed and ordinal scaled data, the difference in median was tested using man Whitney u test.

Participant details

Study was completed within stipulated period with no adverse events and drop outs.

Age (years): The mean age of participants enrolled in the trial was 23.6 ± 5.4 in treatment group and 24.2 ± 6.5 in control group.

Sex: Group - A total of 8 participants were male and 7 were female in treatment group. In control group, a total of 7 participants were male and 8 were female.

Weight (kg): The mean weight of the participants was 53.1 ± 5.3 in treatment group and 54 ± 4.5 in control group.

Body mass index(Kg/m²): The mean BMI of the participants in treatment group was 20.2 ± 2 and in control group was 21.1 ± 3.

Religion: In treatment group, a total number of 11 participants were Hindus, 2 were Muslims, and 2 were Christians. In control group, a total of 14 patients were Hindus, and 1 was Christian.

Type of Sports involved: In treatment group, participants were involved in the following sports: badminton (5), cricket (6), football (1), Kabbadi (2), and volley ball (1). In control group, the participants were involved in the following sports: badminton (4), cricket (5), football (2), Kabbadi (3), and volleyball (1).

Time since injury (hours): The mean time of the injury in treatment group was 23.2 ± 3 and in control group was 24.1 ± 4.

Mechanism of Injury: In treatment group, the inversion type of injuries was more (12) than the eversion type (03). In control group, the inversion type of injuries was 11 and the eversion type was 3.

Type of ankle sprain

Medial ankle sprain: In treatment group it was 03 and in Group B it was 04.

Lateral ankle sprain: In treatment group, it was 12; in control group, it was 11.

3. Results

Effect of Integrated/Standard therapy on ankle pain – Assessment of pain was done through VAS (Visual analogue scale) and VDS (Verbal descriptive scale). Within group results showed 97% (p < 0.05) (VAS), 98% (p < 0.05) (VDS) improvement from baseline to 6th, 11th and 18th day in treatment group and 76% (p < 0.05) (VAS), 76.38% (p < 0.05) (VDS) in control group respectively. Comparison of group results i.e.in between groups showed significant improvement in the results in treatment group over control group from 6th day (p = 0.001), 11th day (p = 0.001), and 18th day (p = 0.001), in both VAS and VDS. (Table 2)

Table 2.

Comparison of outcome variables from Baseline to Day 18

Outcomes	Time points	Treatment			Control			U-value	Z-value	P-value
		Mean	SD	Mean rank	Mean	SD	Mean rank
VAS	Baseline	8.27	1.10	15.17	8.33	1.05	15.83	107.50	−0.1867	0.8519
	Day 6	3.13	0.74	8.00	6.40	0.99	23.00	0.00	−4.6455	0.0001∗
	Day 11	1.40	0.63	8.13	4.27	1.03	22.87	2.00	−4.5626	0.0001∗
	Day 18	0.20	0.41	8.40	2.00	0.76	22.60	6.00	−4.3967	0.0001∗
VDS	Baseline	8.13	0.92	14.00	8.47	0.99	17.00	90.00	−0.9125	0.3615
	Day 6	3.53	1.06	8.40	6.40	0.83	22.60	6.00	−4.3967	0.0001∗
	Day 11	1.40	0.83	8.10	4.20	0.77	22.90	1.50	−4.5833	0.0001∗
	Day 18	0.13	0.35	8.27	2.00	0.76	22.73	4.00	−4.4796	0.0001∗
Tenderness (by grading)	Baseline	3.33	0.72	14.53	3.53	0.52	16.47	98.00	−0.5807	0.5614
	Day 6	1.47	0.64	9.87	2.53	0.52	21.13	28.00	−3.4842	0.0005∗
	Day 11	0.67	0.62	10.60	1.53	0.52	20.40	39.00	−3.0279	0.0025∗
	Day 18	0.13	0.35	10.50	0.80	0.41	20.50	37.50	−3.0901	0.0020∗
Manual muscle testing (by grading)	Baseline	0.9	0.5	16.4	0.8	0.4	14.6	99.00	0.5392	0.5897
	Day 6	2.4	0.6	21.0	1.4	0.5	10.0	30.00	3.4012	0.0007∗
	Day 11	3.7	0.6	21.0	2.7	0.5	10.0	30.00	3.4012	0.0007∗
	Day 18	4.3	0.5	22.3	3.1	0.4	8.7	10.00	4.2308	0.0001∗

∗p < 0.05. Significant changes are considered only when ‘p’ is less than 0.05.

Effect of Integrated/Standard therapy on ankle tenderness – Assessment of tenderness through grading (within group) showed 96% (p < 0.05), improvement from baseline to 6th, 11th and 18th day in treatment group and 77.36% (p < 0.05), in control group. Comparison of group results (in between) showed improved results in treatment group over control group from 6th day (p = 0.001), 11th day (p = 0.0039) and 18th day (p = 0.045) (Table 2)

Effect of Integrated/Standard therapy on ankle Swelling – Within group results showed 't’ value 80.0603 (p = 0.0001) improvement from baseline to 6th, 11th and 18th day in treatment group and ‘t’ value 19.0602 (p = 0.0001), in control group. Comparison of group results (in between) showed better results in treatment group compared to control group from 6th day (p = 0.001), 11th day (p = 0.001) and 18th day (p = 0.001) (Table 3).

Table 3.

Comparison (Between the group) of primary outcomes from Baseline to Day 18

Outcomes	Time points	Treatment		Control		t-value	P-value
		Mean	SD	Mean	SD
Swelling (centimeters)	Baseline	54.43	1.33	54.71	1.38	−0.5788	0.5673
	Day 6	51.16	1.21	53.47	1.27	−5.1029	0.0001∗
	Day 11	49.55	1.07	51.85	1.13	−5.7182	0.0001∗
	Day 18	48.49	1.24	50.46	1.03	−4.7350	0.0001∗
Ankle dorsiflexion (in degree)	Baseline	10.40	2.47	9.33	1.91	1.3234	0.1964
	Day 6	14.95	2.02	11.72	1.94	4.4752	0.0001∗
	Day 11	17.63	1.18	14.38	1.83	5.7928	0.0001∗
	Day 18	19.93	0.98	16.53	1.85	6.2999	0.0001∗
Plantar flexion (in degree)	Baseline	11.08	2.63	11.40	3.37	−0.2900	0.7739
	Day 6	18.00	2.57	15.18	3.09	2.7171	0.0112∗
	Day 11	24.07	2.16	20.79	3.35	3.1859	0.0035∗
	Day 18	31.67	2.00	27.77	3.46	3.7880	0.0007∗
Inversion (in degree)	Baseline	6.00	2.77	6.43	4.02	−0.3436	0.7337
	Day 6	12.09	3.99	9.23	3.76	2.0148	0.0536
	Day 11	18.57	4.88	14.33	3.86	2.6369	0.0135∗
	Day 18	23.07	4.11	18.93	3.81	2.8570	0.0080∗
Eversion (in degree)	Baseline	2.63	3.00	3.23	2.57	−0.5880	0.5613
	Day 6	8.57	2.27	5.60	1.98	3.8143	0.0007∗
	Day 11	13.60	2.62	9.93	2.40	4.0005	0.0004∗
	Day 18	18.13	2.05	14.00	2.91	4.4985	0.0001∗
Temperature (in fahrenheit)	Baseline	101.00	0.32	101.05	0.51	−0.3423	0.7347
	Day 6	96.69	0.52	99.25	0.10	−18.8471	0.0001∗
	Day 11	95.87	0.52	97.53	0.20	−11.5702	0.0001∗
	Day 18	94.89	0.47	96.38	0.23	−11.1203	0.0001∗

∗p < 0.05 Significant changes are considered only when ‘p’ is less than 0.05.

Effect of Integrated/Standard therapy on Range of motion – ROM like ankle dorsiflexion, Plantar flexion, Inversion and eversion - Within group results showed 91% (p < 0.05), improvement from baseline to 6th, 11th and 18th day in treatment group and 77% (p < 0.05), in control group. Comparison of group results (in between) showed significant improvement in the results in treatment group over control group from 6th day (p = 0.001), 11th day (p = 0.0007) and 18th day (p = 0.0016) (Table 3).

Effect of Integrated/Standard therapy on Manual muscle test - Within group results showed ‘Z’ value 3.04 (p = 0.0007) improvement from baseline to 6th, 11th and 18th day in treatment group and ‘Z’ value 3.04 (p = 0.0007) in control group. Comparison of group results (in between) showed improved results in treatment group over control group from 6th day (p = 0.0026), 11th day (p = 0.0062) and 18th day (p = 0.0003) (Table 2).

Effect of Integrated/Standard therapy on Temperature - Within group results showed ‘Z’ value 6.11 (p = 0.0001) improvement from baseline to 6th, 11th and 18th day in treatment group and ‘Z’ value 4.67 (p = 0.0001) in control group. Comparison of group results (in between) showed significant results in treatment group over control group from 6th day (p = 0.0001), 11th day (p = 0.0001) and 18th day (p = 0.0001) (Table 3).

4. Discussion

Disability of Short term or Long term is always a concern of public health after an acute ankle sprain [15]. Studies report that ankle joint laxity and instability persists up to six months after the injury [15]. Rehabilitation of ankle injuries comprises of managing the acute inflammation, restoring full ankle movements, enhancing proprioceptive abilities, muscle power and strength development [16]. Progressive training activities concerned to strength and balance, flexibility exercises and other treatment modalities helps to achieve above goals [16]. In Ayurveda, marmabhighta/vrana pathophysiology includes aaghata (Fall/trauma) to a particular joint/structure leading to production of Vedana (pain), Shopha (swelling) due to Ushnaguna vruddhi by Pitta, Rakta and Vata involvement. Immediate treatment includes sheeta chikitsa like lepa, seka, etc.; later assessment of the dosha and incorporation of shastiupakrama is highlighted [17]. The same principles are utilized in the present study in the form of developing protocol. Combining two therapeutic modalities, such as physiotherapy and Ayurveda, may provide comprehensive care and promote positive therapeutic results.

Pain and Swelling – Significantly improved results were observed in the treatment group based on VAS and VDS assessments. Recent research has proved that Manjistadi lepa (ML) (Fig. 3 A) as cold anointment reduces pain (Table 2), swelling and local rise of temperature (Table 3). Ingredients of ML possess properties like Madhura (sweet), Tikta rasa (bitter taste), vata-pitta shamaka (pacify), Vedanahara (alleviates pain), Raktaprasadaka (Improves blood circulation) and Vedana-sthapaka (Pain reliever) [18]. According to previous research, cold application reduces metabolic demand by producing vasoconstriction, decreasing the severity of subsequent cell damage and the amplitude of the inflammatory response [19]. Alleviation of pain was seen due to reduction in oedema, decreased nerve damage and spasm of muscles. The use of a Kusha (splint) and banding to compress the ankle region helps to stop haemorrhage and reduce swelling (Fig. 3 A). It reduces the amount of oedema induced by the exudation of fluid into the tissue from damaged capillaries [20]. Murrivenna Taila (oil) (Fig. 3 B) comprises of drugs like Karanja (Pongammia pinnata), Kumari(Aloe vera), Shigru(Moring oleifera) which contains Tikta rasa (Bitter taste), Ushna Virya (Hot potency) and they are known to possess vedanahara property [4]. Drugs like Shatavari(Asparagus racemosus), Vidarikanda (Pueraria tuberosa), Bala (Sida cordifolia), Guduchi (Tinospora cordifolia) possess Madhur Vipaka (Sweet in end product of digestion), Tikta rasa (Bitter taste), Sheeta Virya (Cold potency) thus does Raktaprasadana (Improves blood circulation) there by reduces pain and swelling [4]. Marma gutika (tablet) is a sahasrayoga unique formulation including 35 ingredients that is commonly used in the pain treatment of marmaaghata (damage to vital structures) [21]. Recent research on grade 1 ankle sprain treated with standard physiotherapy programme showed reduction of VAS from 8.55 to 6.57 after 1 week, in our study treatment group showed better result i.e. 8.27 to 3.13 [22]. A study carried out using cryotherapy and ultrasound showed a change of VAS from 7.69 to 4.68 after 1 week, but in the present study treatment group showed better results [23].

Fig. 3.

Stages of Ankle sprain Rehabilitation.

Range of motion - Significant improvements were observed in the treatment group based on Goniometer assessments (Table 3) (Fig. 3). Transcutaneous electrical nerve stimulation (TENS) (Fig. 3 B) is a nonpharmacological therapy that is widely utilized in the treatment of both acute and chronic pain [24]. It activates a complex neuronal network, activates large diameter afferent fibers thus reduces pain as per pain gate mechanism. TENS stimulation causes collagen fibre maturation, as well as fibroblast proliferation, thus reduction in pain improves the range of motion [24]. In post ankle injury, increase in strength of muscles, proprioceptive sense, reduction in dysfunction and pain can be achieved by regular practice of rehabilitation exercises [25]. Exercise and mobilization strategies have been demonstrated to help recover ankle function, range of motion, and strength in a previous study [26] (Fig. 3 B). Exercise reduces atrophy, aligns collagen fibers and improves tissue oxygenation and nutrition [27]. Active assisted movements can help to strengthen muscles, tendons, and ligaments and also improves joint integrity [27] (Fig. 3 B). Improved Muscle strength, endurance and postural stability is attained by resisted exercise training [27]. According to research by Bleakley and colleagues, patients who underwent exercises and received rest, ice, compression, and elevation (RICE) one week after their injuries had better ankle function than those who underwent RICE but started exercising a week later [28]. Mattacola and Maureen have recommended ROM exercise as well as isometric and isotonic strength trainings for the early rehabilitation of acute ankle sprains. Achilles tendon stretching using a towel was recommended for restoring ROM in early ankle sprain [29].

Temperature – Significant decrements were observed in the treatment group based on Goniometer infrared thermometer assessments (Table 3). Swelling and local rise of temperature is due to ruptured blood vessels, local inflammation and vasodilatation. The application of cold is believed to induce vasoconstriction, which lowers the permeability of nearby blood vessels and lessens the extent of bleeding following injury [30]. Applying Manjistadi Lepa following an acute injury results in instantaneous vasoconstriction of the venules and arterioles, decreasing local circulation and fluid extravasation into the interstitium, ultimately lowering local temperature and oedema [31]. The treatment group with integrated approach has shown better results due to the inclusion of Ayurveda procedures like lepa application, oral medications etc.

Manual muscle test - Previous research has shown relief in heaviness and stiffness of muscles (Table 2) along and improvement in muscle strength was achieved with local massage with murivenna oil followed Shastikashali pinda sweda (bolus fomentation of boiling rice grains knotted in a piece of cloth) [32,33] (Fig. 3 C). Massage is a rhythmic mechanical stimulation of the body's soft tissues that aids in the improvement of range of motion, improved circulation, lymphatic drainage, overall relaxation, and pain alleviation [34]. Strength-training exercises helps in developing muscles and improve neuromuscular control, helps in returning back to play after injury [35]. Practice of Thera-band exercises serve to strengthen the muscles of the dorsiflexors, plantar flexors, evertors, and invertors [36] (Fig. 3 C). Endogenous opioids (endorphin and encephalin) are produced when inferential treatment is used, which inhibit pain transmission at the spinal level [37]. It stimulates muscles, reduces swelling, enhance circulation of blood and hastens process of healing [37]. In the case of an ankle sprain, ultrasound can help to relieve pain, swelling, and enhance joint mobility [38] (Fig. 3 C). It enhances blood flow, lowers muscular spasms, increases collagen fibre extensibility, and suppresses the inflammatory response [38]. Bala (Sida cordifolia L.) and Ashwagandha (Withania somnifera L.) are the active constituents in the Balaristha, and they have been shown to build muscles by supplying nutrients to the tissues, thereby enhancing the endurance of athletes [39]. The treatment group with integrated approach has shown better results due to the inclusion of Ayurveda procedures like lepa application, oral medications etc. which has enhanced the healing process there by reducing the pain, swelling and increasing the range of the motion.

Limitations of the study – The study has provided significant results in the assessed parameters but the sample size was very less, as it was academic dissertation work due to the factors like time period, availability of cases, cost of multiple treatments, which restricted us to choose less sample size. Gender disparities in both the groups and combined responses are other limitations.

5. Conclusion

Ankle sprain requires multidimensional approach towards the diagnosis and management to attain a desired treatment outcome. The designed protocol with integrated approach has given significant results than the standard group in the tested parameters like pain, swelling, local temperature, range of motions, and manual muscle testing. The common mistakes in the assessment and management of ankle sprain are unnecessary imaging, undue non-weight-bearing, unwarranted immobilization, and delay in functional movements. The practice of an evidence-based protocol approach with consideration of individual characteristics is highly recommended in addressing such issues. Further research works with larger sample size and advanced assessment techniques are required in this direction to develop evidence based practices and boost the integrated approach.

Author contribution form

DDG: Conceptualization, Methodology/Study design, Validation, Formal analysis, Investigation, Resources, Data curation, Writing – original draft, Writing – review and editing, Visualization, Supervision, Project administration, Funding acquisition. RSK: Conceptualization, Methodology/Study design, Validation, Formal analysis, Investigation, Resources, Data curation, Writing – original draft, Visualization, Project administration, Funding acquisition. PSS: Conceptualization, Methodology/Study design, Validation, Formal analysis, Data curation, Writing – original draft, Writing – review and editing, Supervision, Funding acquisition. DB: Conceptualization, Methodology/Study design, Validation, Formal analysis, Data curation, Writing – original draft, Writing – review and editing, Supervision, Funding acquisition.

Declaration of generative AI in scientific writing

No AI assistance was used in the drafting the article.

Source of funding

None.

Conflicts of interest

None.

Appendix A. Supplementary data

The following is the Supplementary data to this article.