1] Introduction-

      Acharya Sushruta, the father of Surgery has included Avabahuka and Anshashosha in vatavyaadhi.^[1] The description of Avabahuka is also available in Charak Samhita^{[2, 3],}Ashtanga Hirdaya.^[4]  The general causes of Avabahuka are intake of excess vatavardhak ahara-vihara, trauma at neck region, dislocation of shoulder joint, fracture of clavicle, injury in brachial plexus. The Anshamarma is a vaikalyakar type of marma (vital point) that’s injury causes to stabdhata (tatrastabdhabahuta”(Su. Sha.6/27) .The similar features seen in Avabahuka diseases. The common features of Avabahuka are sira-sankocha at Ansha-sandhi, loss of functional activity of arm (baahu- praspandithar), atrophy of arm (bahu- shosha) (anshamool sthitovaayu sira-sankochyatatragaah, baahupraspandit-haram janyatayavabaahukam – A.H.Ni.15/43, karmakshaya of bahu (arm).  The treatment mentioned in Ayurveda for Avabahuka are nasya karma, snehapaan, food after intake of sneha, local abhyanga-swedana (oleation - sudation^)[5]. The Sushruta mentioned that the main cause of Avabahuk is vataprakopa at shoulder region and the treatment of snayu-sandhi-asthigatavata is by repeated snehana (oleation), upnaha (poultice application), agnikarma (intentional therapeutic heat burn therapy), bandhan (bandaging), mardan (massage)(S.Ci.5/8) ^[6]. Sushruta also mentioned to do vatavyadhichikitsa in cases of Avabahuka (S.Ci.5/23). The Avabahuka is correlated with frozen shoulder as described in modern medical science ^[7]. Somewhere the Avabahuka mentioned as paralysis of brachial plexus and Ansha-shosha as atrophy of shoulder joint.^[8]

     The term frozen shoulder, adhesive capsulitis, painful stiff shoulder, periarthritis are used synonymously. The American Academy of orthopaedic surgeons define the frozen shoulder as global restrictive active and passive  movement of shoulder joint which develop gradually with variable severity. Also no significant radio graphical features seen except osteopenia.^[9]   Most of the cases of frozen shoulder are idiopathic and some have secondary origin like trauma, after surgery etc. ^[10]. Mostly the patient managed in the primary care setting by patient education, explaining natural history, increase compliance and removing fears.^[11]. Generally the full range of movement not restored completely. The NSAIDS ^[12] (nonsteroidal anti-inflammatory drugs), glucocorticoids, intra-articular injections, physical therapy are common methods to cure frozen shoulder^{.[13, 14].} The NSAIDs reduces the pain and swellings.

     The Agnikarma mentioned in Ayurveda as a simple intentional therapeutic heat burn therapy in heads of parasurgical procedure. It is indicated in various medical and surgical diseases like musculoskeletal diseases, tennis elbow, Avabahuka, backache, osteoarthritis, corn, wart, mole, sinus, haemorrhage, etc. It is performed with the help of Agnikarma shalaka at specific site in particular way^{. [15].}

1.1] Rationale of the study-

       The common conservative treatment of frozen shoulder is anti-inflammatory analgesic drugs, but it is not helpful in curing the diseases. The different modalities like marma therapy, physiotherapy, surgery etc. also available for treatment of frozen shoulder but have their limitations. The Physiotherapy requires costly instruments and is time taking procedure with their own complications. The surgical treatment mostly available at higher centre, which is not an easy task and costly. The diclofenac gel have mainly pain relieving effect. The non-pharmacological treatment marma therapy are in practice but not have an established treatment.

      It is worth mentioning that Agnikarma is day care procedure and non-pharmacological management of pain and stiffness of frozen shoulder. Various researches on effect of agnikarma on frozen shoulder have been published in various journals. The agnikarma is vata and kapha shamak modality so selected for treatment of Avabahuka (vatavyaadhi). The Classics of Ayurveda such as Sushruta Samhita has categorized Agnikarma in parasurgical procedure for treatment of vataja and kapahaja diseases, pain management etc. In other words, Agnikarma is indicated in snayu-asthi-sandhigatavata (Sushruta chikitsa vatavyaadhi 5/8) in vatavyaadhichikitsa. It is non pharmacological, cost effective, economically viable, easy to perform, even at remote areas and day care procedure for management of Avabahuka.

1.2] Previous work done

1.      Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder.

Singapore Med J. 2017; 58(12):685–689. doi:10.11622/smedj.2017107

2.      Lilke DhanaWaman, GiriSeema Rajesh, KasleVitthal K, Role of Agnikarma (Cauterization) in

the management of Frozen shoulder. Ayurline: IJRIM, April-June 2017 | Vol. 01 | Issue: 02 e-ISSN: 2456-4435

3.      Nirmal et al., Management of Avabahuka (Frozen Shoulder) with Abhyanga Swedana, Pratimarsha Nasya and Ayurveda Medicines: A Case Study, World Journal of Pharmaceutical Research, Vol 6, Issue 8, 2017, p.2099-2103, ISSN 2277–7105

4.      Tyagi Megha,  A pilot study of Agnikarma on frozen shoulder (Avabahuka), M.S.(Ay) ShalyaTantra, RGUHS Karnataka,2011

5.      Aswar et al. Review on effect of Atasi upanaha in Avabahuka with special reference

to amsamarma World Journal of Pharmaceutical Research

Volume 7, Issue 19, 586-594.

6.      Dhanokar CA, Kanani VP (2017) Management of Frozen Shoulder by

Agnikarma (Therapeutic Cauterization) and Patrapinda sweda (Herbal Hot Fomentation):

A Case Study.Am J PhytomedClinTher. Vol. 5 No. 3:18. doi:10.21767/2321-2748.100331

7.    Vaneet Kumar etal., Role of Agnikarma in degenerative disorders W.S.R. Avabahuka

 (Frozen shoulder)- Case study. Science of life, Bhopal MP, Dec -2012.

8.    Ganapati Rao etal., Agnikarma in the management of Avabahuka, IJCR Bidar Karnatak, March 2017

9.      Prasad Shirish etal, Clinical evaluation of Marma therapy in Avabahuka W.S.R. to frozen shoulder

JMSCR May 2017 Haridwar.

 

 

1.3] Case definition

            Diagnosed cases of Avabahuka (frozen shoulder). The patient should have normal X -Ray shoulder with sign symptoms of Avabahuka (frozen shoulder) i.e. Ansha-desha-sthit vaayu (affected shoulder region), shool (pain), stambha (stiffness) and bahupraspandithar (significant restriction of movement).

1.4] Research Question:

          Whether the Agni karma is more efficacious as compared to topical diclofenac sodium gel application in the management of Avabahuka (Frozen shoulder)?

1.5] Hypothesis:

·         Alternative Hypothesis (H₁): Agnikarma is more efficacious in the management of frozen shoulder as compared to topical diclofenac sodium gel application.

·         Null Hypothesis (H₀): There is no difference in efficacy between Agnikarma and topical diclofenac sodium gel in the management of frozen shoulder.

 

[2] Literary review:

A) Review of disease:

       Ayurvedic review: In Ayurveda the bodily disease mainly caused by due to vitiation of vata, pitta or kapha doshas. The disease caused by Vata dosha are grouped in category of Vata-vyadhi. The Avabahuka disease is a type of vatavyaadhi as mentioned in Ayurveda literature. The famous Ayurvedic classics Sushruta Samhita, Charak Samhita, Ashtanga Hridaya and Ashtanga Samgraha have description of Avabahuka.

 

Avabahuka disease affects Ansha-sandhi (shoulder joint) and is related with Ansha-marma. The basic feature of Avabahuka disease are Ansha-desha-sthit vaayu (affected shoulder region), shool (pain), stambha (stiffness) and bahupraspandithar (significant restriction of movement). Various treatment modalities are stated in classics for the treatment of vatavyaadhi and Avabhuka like sneha-paan, snehan- swedan, upnaaha, agnikarma, bandhan, mardan, nasyakarma. One of them is Agnikarma, which is a parasurgical procedure and is indicated in diseases caused by vata and kapha doshas. The detail description of Agnikarma including its superiority, indication, contraindication methods, types are available at Sushruta Samhita sutra sthana chapter 12 (Agnikarma vidhi adhyaaya) and Charak chikitsa sthana chapter 25. Clinically, the Agnikarma is indicated as therapeutic procedure for the treatment of Avabahuka [^16] . On observing the sign symptoms the Avabahuka disease is more nearer to frozen shoulder of modern science and mentioned in related research article.

Modern review: The word frozen shoulder, adhesive capsulitis or periarthritis shoulder used synonymously. The disease frozen shoulder means chronic painful stiff shoulder joint. The frozen shoulder is musculoskeletal ailment and commonly seen in orthopaedic clinics. The estimated prevalence of frozen shoulder is 3 – 5 % in general population ^[17] and 10-20% in diabetes mellitus patients. As per American Shoulder and Elbow Surgeons the frozen shoulder have non-specific idiopathic causes and features of restricted active- passive movement of shoulder joint without known intrinsic shoulder joint disorder. ^[18] The detail description regarding definition, various types (phases), diagnosis, treatment modalities (conservative and surgical) and prognosis are available in orthopaedics books. The disease mainly assess by intensity of pain, stiffness and reduce range of movement (ROM) of shoulder joint. The frozen shoulder have three stages of altered symptoms. The stages are respectively painful phase (initial stage, freezing phase), stiffening phase (frozen phase) and thawing phase (resolving phase ^[19]. The aim of treatment is to reduce shoulder pain and to increase the range of movement of shoulder joint as earlier. The analgesic drugs, non-steroid anti-inflammatory drugs (NSAID,s, oral or injection), corticosteroid (oral or injection), physical therapy (physiotherapy, exercise), joint distension, hydro dilatation, surgical therapy, shoulder manipulation, arthroscopic therapy are various medical and surgical treatment.

B) Drug Review:

·         Agnikarma ^[20] – The agnikarma is a parasurgical procedure mentioned in ancient text. It is simply an intentional therapeutic heat burn therapy and is helpful in subsiding the pain (shool), relieving the stiffness (stabdhata). Agnikarma is Vata and kapha shamak therapeutic procedure, if perform properly (samyak dagdha). Agnikarma in samyak dagdha at shoulder region skin will perform with the help of copper made Agnikarma shalaka for a specific site and time. The initial preparation, main action and post therapy care norms will follow as described in methodology section.

·         Diclofenac sodium gel ^[21] - The diclofenac sodium is a NSAIDs (Non-steroidal anti-inflammatory drugs) that reducing the pain and inflammation. These are non-opioid analgesics. NSAIDs blocks the cox enzyme and reduce prostaglandins throughout the body, so stopped the ongoing pain and inflammation. The common side effects of oral analgesics are gastritis, epigastric pain, headache, gastric ulceration, rashes etc. The local application of diclofenac sodium gel is chosen to avoid systemic side effect of NSAIDs. The gel preparation are water based semisolid used topically with good adherence and spreading property.

A.2.1] Research Gaps Analysis

        Various modern surgical and medical treatments are in vogue on this disease but all treatments have certain limitations and range of cure. Ayurveda has its own way of treating frozen shoulder by Agnikarma which is a minimal invasive parasurgical measure capable of subsiding Vata and Kapha dosha, by virtue of its ushna guna (hotness) and heat. Many research scholar conducted studies to find out effectiveness of Agnikarma in frozen shoulder as a pilot work on small scale. The documented reports and clinical practice shows its significant effectiveness. But the work on comparative study of Agnikarma with Diclofenac sodium gel (topical NSAID) not done till now. The topical analgesic drugs are frequently used in primary care to reduce the pain and inflammation seen in society. So this study is plan to compare the effect of Agni karma with standard topical diclofenac sodium gel. Also to evaluate the efficacy of said Agni karma in the management of Avabahuka (frozen shoulder).

3] Aim and objectives

3.1] Aim: To compare efficacy of Agnikarma and topical Diclofenac sodium gel in the

               management of Avabahuk (Frozen shoulder).

 

3.2] Objectives:

1.      To assess efficacy of Agnikarma in management of pain intensity and shoulder range of motion (ROM).

2.      To assess efficacy of Diclofenac sodium gel in Management of Avabahuk (Frozen shoulder).

3.      To compare efficacy of Agnikarma and topical diclofenac sodium gel in the management of Avabahuk (Frozen shoulder).

 

4] Material and method

4.1] Source of Data: Participants will be selected from OPD and IPD of Shalya Tantra

Department, Mahatma Gandhi Ayurved College, Hospital and Research centre (MGACHRC), Salod (H),

Wardha.

4.2] Study design: A randomized control trial (RCT)-Reference standard control trial, open study.

4.2.1] Type of Study: Interventional

4.2.2.] Sampling technique: Random sampling by computerized table method.

4.2.3] Grouping:

Group A –Agnikarma

Group B – Topical Diclofenac sodium gel

4.2.4] Sample size: The sample size will be decided after pilot study. The study will be conducted

in two phase.

Phase 1	·         Pilot study on 12 patient ·         To determine effect size which is required for calculation of sample size.
Phase 2	Full research work

 

4.2.5] Population: Patients diagnosed as Frozen shoulder from OPD and IPD of Shalya Tantra department,

MGACH and RC Salod (Hi), Wardha.

4.3] Data collection tools and process:

Participants fulfilling inclusion criteria will be enrolled for study.

The selected participant will be informed about possible outcome and side effects

of interventional drug.

4.3.1] Inclusion criteria

a)      Participant with clinical features of Avabahuka (frozen shoulder) having unilateral involvement will be included after screening.

b)     Participant with age Group of 40 to 70 years.

c)      Participant irrespective of sex, occupation and economic status.

d)     Participants willing to give written informed consent

4.3.2] Exclusion criteria

a)      Participant suffering with hypertension, tuberculosis, HIV, hepatitis B, known cases of malignancy, gastritis

b)      Diabetes mellitus patient having fasting blood sugar more than 200 mg /dl and

Less than 70 mg /dl

c)      Patient have past history of shoulder joint surgery

d)     Patient have history of fracture of shoulder joint, malunion, traumatic arthritis.

e)      Highly immunocompromised patient.

f)       Patient have major psychiatric illness.

g)      Pregnant lady, lactating mother

h)      Patient not willing in participation of study.

4.3.3] Screening Parameters:

a)      Complete blood count

b)      Erythrocyte sedimentation rate

c)      Blood sugar fasting

d)     HIV

e)      HBsAg

f)       X-ray shoulder joint AP and lateral view.

 

4.4.] Assessment Criterion

4.4.1] Subjective parameters

1. Pain

2. Local tenderness

2. Stiffness

Grading of Subjective parameters

1.      Assessment criteria of Pain (shool) -  VAS scale

                                   The grading for assessment of pain

No pain	0
Mild Pain, Can do taxing work with difficulty	1
Moderate pain, can do normal work with Support	2
Severe pain unable to do any work	3

 

2.      Assessment criteria of local tenderness

                                  The grading for assessment of local tenderness

No tenderness	0
Patient complain of tenderness	1
Patient complain of pain and winces	2
Patient complain of pain and withdraw the joints	3
Patient does not allow to touch the joint	4

 

3.      Assessment of stiffness

                    The grading for assessment of stiffness

No stiffness	0
Mild, has difficulty in moving the joints without support	1
Moderate has difficulty in moving can lift only with support	2
Severe Unable to lift	3

4.4.2] Objective parameter – The ranges of movements (ROM) were considered as the objective

parameters. The ROM namely flexion, extension, abduction, internal rotation & external rotations

 will record according to the actual values of goniometric readings.

The grading for assessment of joint mobility or Range of movement (ROM)

For abduction			For elevation
G0 G1 G2 G3 G4	>80 <90 61-80 41-60 21-40 0-20		G0 G1 G2 G3 G4	>160 <180 121-160 81-120 41-80 0-40
For adduction			For flexion
G0 G1 G2 G3 G4	>160 <180 121-160 81-120 41-80 0-40		G0 G1 G2 G3 G4	>160 <180 121-160 81-120 41-80 0-40
For extension
G0 G1 G2 G3 G4	50-60 40-50 30-40 20- 30 0-20

 

ROM	Positioning of goniometer	Normal (AMA-American Medical Association)
Flexion	The range of flexion was recorded in supine position and arm resting at the side of the body with palms facing medially is taken as 0 degrees. The fulcrum of the goniometer is placed over the acromion process. The stationary & moving arms are aligned with the midline of the humerus & lateral epicondyle.	1500 (AMA)
Extension	The range of extension was recorded in prone position and arm resting on the side of the body with palms facing medially is taken & head facing away from the shoulder. Elbow should be bent slightly & the palm facing in towards the body .The fulcrum is placed over the acromion process. The stationary & moving arm are aligned with the lateral midline of the humerus & the lateral epicondyle.	500 (AMA)
Abduction	The range of abduction was recorded in supine position and arm resting on the side of the body with palms facing anteriorly. The fulcrum is placed at the acromion process. The stationary & moving arms are aligned with the anterior midline of the humerus. The stationary arm should remain still & parallel to the sternum	1800(AMA)
Internal Rotation	The range of internal rotation was recorded in supine position with 90 degrees of shoulder abduction and the elbow is in 90 degrees of flexion with palms facing medially. The fulcrum should be centered over the olecranon process. The moving arm is aligned with the ulnar styloid & the stationary arm should be perpendicular to the floor.	900(AMA)
External Rotation	The range of external rotation was recorded in supine position with 90 degrees of shoulder abduction and the elbow is in 90 degrees of flexion with palms facing medially. Fulcrum should be on the olecranon process. The moving arm should be aligned with the ulnar styloid &the stationary arm should be perpendicular to the floor.	900(AMA)

 

Assessment of Result - Criteria for assessment of the overall therapy ^[22]

·         Complete relief - One hundred percent relief in the complaints of patients, along with elevation of shoulder joint up to 180° and flexion and abduction of the joint up to 90°.

·         Marked improvement - More than 75% relief in the complaints as well as significant improvement in the elevation of joint up to 135°, and flexion and abduction up to 60°.

·         Moderate improvement - More than 50% relief in the complaints along with improvements in elevation of joint up to 90° and flexion and abduction of joints up to 30°.

·         Improvement - Twenty-five to fifty percent relief in the complaints.

·         Unchanged - Patients with less than 25% relief in their complaints were regarded as unchanged.

 

4.5] METHODOLOGY-

     This is a randomized control trial (RCT), will be conducted at Shalya Tantra department of

Mahatma Gandhi Ayurved College, Hospital and Research centre, Salod (H), Wardha.

The compliance of the treatments will be monitored asking the patients to fill the pre-designed proforma.

Group A – Agnikarma + physiotherapy

Group B - Diclofenac sodium gel – Topical application + physiotherapy

 

Group A Agnikarma	A.    Poorva-karma ·         Diagnose case of frozen shoulder ·         Informed written consent ·         Local part preparation with dashmool kwath ·         Collect the required material Aloe vera pulp, yastimadhu powder, sponge holder, gauze piece, cotton, bandage ·         Copper made Agnikarma Shalaka   B.     Pradhan karma ·         Site of Agnikarma at supero- posterior and lateral aspect (including deltoid insertion area) of shoulder joint, locally, tender side at shoulder region. ·         Bindu type agnikarma = bindu will be made ·         By copper made pointed shalaka (dahanopkarana) in red hot condition, exposure time 1 second, and creating specific sound “chit”.   C.     Paschaat karma   ·         After Agnikarma application of Aloe vera pulp (gel) and yastimadhu churna. ·         Application of bandage for 24-48 hours and advice to protect it from soaking or any contamination. D.    Frequency of Agnikarma – At every week on same days for 4 sitting. E.     Duration of therapy – 4 week F.      The fresh Aloe vera pulp applied at burn side with yastimadhu powder after each sitting..
Group B   Diclofenac sodium gel – Topical application	·         Topical application of Diclofenac sodium gel ·         Thin layer of gel, two times in a day morning evening, with gentle massage at affected shoulder region ·         Total days of application 4 weeks. ·         Avoid trauma, do not cover or bandage after its application.
PHYSIOTHERAPY In each group the same physiotherapy (mobilization exercise) will offer. Pre-procedural method: Obtained the consent regarding the procedure. Position the subject in a chair, or sitting or lying on a bed. Method: Advice shoulder movement within the range of comfort and with maximum range. Instruct all not stretch suddenly, roughly, forcefully but do gently. Each of these gentle stretch needs to be held up to a count of 100, three rounds in a day. 1.      Getting the arm up while lying down 2.      Getting the arm up overhead while sitting down. 3.      Getting the arm to externally rotate while lying down. 4.      Getting the arm to externally rotate while standing. 5.      Getting the arm up the back. 6.      Getting the arm across the body. (Reference- https://orthop.washington.edu/patient-care/articles/shoulder/home-exercises-for-the-stiff-or-frozen-shoulder.html)