NEED FOR THE STUDY

1. INTRODUCTION

Adhesive capsulitis or frozen shoulder is an inflammatory disorder characterized by severe shoulder stiffness, discomfort, and loss of passive range of motion, with a prevalence of 2% to 5% among the general population and 20% among diabetes mellitus, slightly higher in females and commonly affected at the mean age of 55.^[1] Many reports explain that the conservative treatment option for adhesive capsulitis is successful in up to 90% of the patients ^[2], yet now there is no consensus regarding treatment recommendations despite the high prevalence. The use of naturopathic treatment methods in patients with chronic diseases or those at risk for them has been shown to improve health outcomes and quality of life.^[3] Mud therapy is a relatively straightforward, inexpensive, and effective Naturopathic treatment method. One of the five natural elements, mud, has a significant impact on both health and disease in humans. The beneficial results are brought due to the cool moisture in and under the packs or poultices which relax the pores of the skin, draw the blood in to the surface, relieve inner congestion and pain, and promote heat radiation and elimination of morbid matter. It is true that in many cases of chronic inflammation resulting either from internal disease, bruises or sprains, clay packs have proved of great benefit.^[4] Recent research shows that mud therapy helps in reduction of inflammatory markers.^[5] The effects of sunlight is very essential for life on this planet without it would be impossible. Everything that draws the breath of life depends for vital energy upon the life-giving rays of the sun.^[4] One of the main treatments utilized in naturopathy is the sunbath also called heliotherapy. Sun the primary component of the fire element is used therapeutically. Current research shows that sunlight exposure to skin can bring anti-inflammatory effect by regulating cytokines, releases endorphin and neuropeptide substance-p helps in local immunological suppression. ^[6] This research study aims to determine the effect of direct mud application to adhesive capsulitis patients followed by therapeutic sun exposure reduces pain, disability and improves the functional mobility of shoulder joint.

 2. LITERATURE REVIEW
Musculoskeletal problems are often marked by discomfort and restrictions in mobility and dexterity, which make it harder for people to work and participate in society.^[7] Frozen shoulder, or adhesive capsulitis, is an inflammatory disorder characterized by severe shoulder stiffness, discomfort, and loss of passive range of motion. In the general population, adhesive capsulitis affects 2% to 5% of people. Usually, the mean age of onset is 55, high prevalent in women. Adhesive capsulitis can be classified into primary and secondary forms. Primary adhesive capsulitis often develops gradually and is idiopathic. It frequently coexists with underlying illnesses such hypertriglyceridemia, thyroid disease, drug use, diabetes mellitus, and cervical spondylosis. Typically, shoulder trauma, injuries such rotator cuff tears, fractures, surgery, or prolonged immobilization result in secondary adhesive capsulitis. According to the predominant theory, inflammation begins in the joint capsule and synovial fluid, followed by reactive fibrosis and adhesions in the synovial lining. ^[1] Patients with type 2 diabetes are more likely to get frozen shoulder. Diabetes was found to increase the risk of adhesive capsulitis by more than three times.^[8]
Maruli Tua Lubis A et al., study stated that currently no consensus regarding treatment recommendation despite the high prevalence. Diverse reports describe the conservative treatment options for frozen shoulder, including physiotherapy, from the earliest techniques, such as the injection of anesthetics and steroids, through the most recent ones, including cryotherapy, pulse radiofrequency of the suprascapular nerve, and oral corticosteroids. According to the available research, supervised neglect is the most effective conservative therapy, and Physiotherapy has been shown to improve clinical outcomes and give enough range of motion. ^[9]
One of the five natural elements, mud, has a significant impact on both health and disease in humans. Mud therapy is a relatively straightforward, inexpensive, and effective Naturopathic treatment method. This mud needs to be clean and extracted between 122 and 153 cm below the ground’s surface. It should be devoid of contamination from things like chemical manures and stone fragments, etc. Mud should be sun-dried, pulverized, and sieved to remove stones, grass fibers, and other pollutants before use. It should be thoroughly heated and therefore sterilized if there is any uncertainty regarding its cleanliness. Mud therapy is one of the straightforward and efficient therapies that is used into healthy living methods. ^[10] Mud is an inorganic, organic, and water-based semi-colloidal substance that has undergone a variety of physical and chemical impacts as a result of geological and biological processes. Mud has a complex chemical make-up that includes organic substances like humic, fulvic, and acetic acids as well as mineral components like Ca2+, Zn2+, Mg2+, and Na+. ^[11]
Slobodian EI et al.,study explains that the intercellular matrix and collagen metabolism of connective tissue change as a result of the systemic response to peloid therapy, which also leads to changes in the process of fibrogenesis. The indirect effects are caused by the peloid’s impact on the antioxidant state, immunity, hormone control, and metabolic activities. ^[12]
Sara Tenti et al., study show that the effectiveness of mud bath therapy was considerable in reducing pain and enhancing functionality in patients with hand osteoarthritis. ^[13]
Fioravanti A et al.,Serum adiponectin levels significantly decreased (p 0.001) at the end of the 15 days of mud-bath therapy, serum resistin levels in the mud bath therapy group significantly decreased (p 0.0001) while they significantly increased in the control patients.^[14] Mud-bath therapy raises levels of the hormones corticotrophin, cortisol, growth hormone, and prolactin as well as plasma levels of endorphins. Recent research has shown that thermal mud-pack therapy reduces circulation levels of key mediators of inflammation and pain, including prostaglandin E2 (PGE2), leukotriene B4 (LTB4), interleukin-1 (IL-1), and tumor necrosis factor (TNF). ^[5] A study on the effectiveness of balneotherapy for fibromyalgia syndrome found a considerable reduction in pain ^[15] and some data suggests that balenotherapy may help Fibro Myalgia Syndrome  sufferers with their pain and quality of life. ^[16]
The five main elements of naturopathy, known as the Panchamahabhuthas, are air, water, earth, fire, and ether. One of the main treatments utilized in naturopathy is the sunbath (also known as heliotherapy) hereby, exposing the body to sunshine for the appropriate amount of time. Sun, the primary component of the fire element, is used therapeutically. ^[17] Sunlight is composed of three major wavelength bands: visible light (wavelengths of 400–800 nm) ultraviolet radiation (wavelength of 100–400 nm) and infrared radiation (wavelengths > 800 nm). The wavelengths of UVR are further divided into three main categories: UVA (315–400 nm) and UVB (280–315 nm), which, respectively, comprise 95% and 5% of UV rays that reach the Earth’s surface; and, UVC (100–280 nm), which is prevented from reaching the Earth’s surface by the ozone layer. UVA can penetrate much deeper into the epidermis than UVB with <10% of UVB reaching the basal germinal layer compared to >20% of UVA. Increased sun exposure is linked to decreased immune-driven disease onset and/or severity, including autoimmune conditions like arthritis. ^[18]
Fatih Okan et al., study revealed that exposure to sunlight for 5 days per week for 4 weeks with an average duration of 21±5 minutes shows increased the 25(OH)D regardless of gender andage. ^[19]
M. Nathaniel Mead explains in his study about the greatest recognized advantage of sunlight is its capacity to increase the body’s vitamin D levels; vitamin D deficiencies are typically brought on by a lack of exposure to sunlight outside. The active form of the vitamin, 1,25-dihydroxyvitamin D3 (1,25[OH]D), is thought to control at least 1,000 different genes, many of which are involved in calcium metabolism, neuromuscular function, and immune system health. Direct immunosuppressive effects from exposure to UVA and UVB radiation can be attained by upregulating the cytokines TNF- and IL-10 and increasing the activity of T regulatory cells, which eliminate self-reactive T cells. UVR raises endorphin levels in the blood, which are a type of natural opioid. The cutaneous pigmentary system may be a key component of the skin’s stress-response mechanism because melanocytes in human skin possess a fully functional endorphin receptor system. CGRP, or calcitonin gene-related peptide. This powerful neuropeptide, which is released in response to UVA and UVB radiation and affects a number of cytokines, is associated with decreased immune induction and the growth of immunologic tolerance. Neuropeptide substance P is released from sensory nerve fibers in the skin after UVR exposure, along with CGRP. Increased lymphocyte proliferation and chemotaxis (chemically mediated movement) are produced as a result, although it may also result in local immunological suppression. ^[6]
Nidhi patel et al study explains that Mud varies depending on where it comes from, and its mineral composition differs depending on the type of local rocks and how the soil is formed. The type of vegetation and wildlife in the area has an impact on the characteristics of mud. The different varieties of mud include moor mud, dead sea mud, and black mud/sapropelic mud. More than 20 different types of salts, minerals, magnesium, calcium, potassium bromide, and organic substances can be found in dead sea mud. The organic waste products of flowers, grasses, and herbs are what create the moor mud. It has humic acids, vitamins, amino acids, plant hormones, fulvic acids, and other nutrients in a form that can be readily absorbed by people.^[20]
Munteanu C et al study shows that mineral and vegetable-mineral muds are produced by the sedimentation of spring salts that have sulfidic, ferruginous, and carbogazeose characteristics. Peloid is a matured mud or muddy dispersion with healing and/or cosmetic properties, composed of a complex mixture of fine-grained natural materials of geologic and/or biologic origins, mineral water or seawater, and common organic compounds from biological metabolic activity. Mineral muds are formed by the sedimentation of salts of carbonaceous, calcium, ferruginous, or sulfurous springs. Peat is a type of organic soil. Peat muds are created when the vegetable residues that have gathered on the bottom of some bogs microbiologically decompose. Physical characteristics of mud include hydropexy (the ability to absorb and retain water), thermopexy (the ability to absorb and store heat), and other characteristics like consistency, specific heat, and plasticity. Peat mud has a high capacity to retain heat. Pharmacodynamic characteristics include the sensitive reception of mud qualities and their transmission to the higher stages of integration and regulation, the exchange of energy and substance with the peloid environment, and the accomplishment of adaptive tasks such as circulatory, secretory, and protective. Peloids’ chemical makeup is alkaline, with a pH range of 9 to 10. ^[21]

 3. AIM & OBJECTIVES:
Aim:
The aim of the study is to evaluate the effect of mud application followed by therapeutic sun exposure on pain and disability among adhesive capsulitis patients.
Objectives:
Primary objective:
Ø  To determine the effect of direct mud application followed by therapeutic sun exposure on pain among adhesive capsulitis patients.
Secondary objectives:
Ø  To determine the effect of direct mud application followed by therapeutic sun exposure on range of movements among adhesive capsulitis patients.
Ø  To evaluate the effect of direct mud application followed by therapeutic sun exposure on functional activity of the shoulder joint among adhesive capsulitis.
NULL HYPOTHESIS:
Mud application followed by therapeutic sun exposure may not have any influence on the pain of adhesive capsulitis.
Mud application followed by therapeutic sun exposure may not have any influence on the range of movements and disability of adhesive capsulitis.
ALTERNATE HYPOTHESIS:
Mud application followed by therapeutic sun exposure may have any influence on the pain of adhesive capsulitis.
Mud application followed by therapeutic sun exposure may have any influence on the range of movements and disability of adhesive capsulitis.
 4. METHODOLOGY:
4.1 Study setting:
The study will be conducted at the department of naturopathy, International institute of yoga and naturopathy medical sciences, chengalpattu.
4.2 Study participants:
Patients come to our out patients department of international institute of yoga and naturopathy medical sciences with shoulder pain will be examined and screened for assessing the adhesive capsulitis using the clinical diagnostic criteria of interscapular scratch test. In Apley scratch test the patient is asked to put his/her arm above head and arrive at behind the neckline to touch his//her upper back. During physical examination if the patient is having severe pain, then the physical assessment is marked positive. Total of 60 participants will be selected based on positive sign of apley scratch test and 30 participants will be randomly assigned to interventional group and another 30 to control group.

4.2.1 Inclusion criteria:
Ø  Age between 40 to 60 and pain minimum 3 months to <12 months duration
Ø  Both male and female, receiving no treatment in last 4 weeks
Ø  Interscapular scratch test positive and pain at night & inability to lie on affected side
Ø  Significant loss of passive range of motion in shoulder joint
Ø  Pain during Passive range of motion

4.2.2 Exclusion criteria
Ø  Subacromian bursitis
Ø  Rotator cuff tendinopathy or tear
Ø  Glenohumeral osteoarthritis
Ø  Fracture
Ø  Malignancy
Ø  Shoulder dislocation
Ø  Secondary adhesive capsulitis
Ø  Photosensitivity patients.
Ø  Open wounds at shoulder region.
Ø  Allergic reaction to mud.

Withdrawal criteria:
Subjects can withdraw from the study at any point of time, for any reason, with or without prior intimation to investigators or with or without prior permission from investigators.

4.2.3 Ethical Consideration:
Institutional ethics committee (IEC) clearance will be obtained from IIYNMS before the recruitment of the first subject. Study protocol will be explained to the subjects and a signed consent in both oral and written will be obtained from each subject.
4.3 Study Design:
Study designed is planned as A Randomized control trial. All the eligible participants will be randomly assigned to two groups by simple random sampling using random number table. Allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed Envelope) technique. Subjects and investigators will not be blinded in the study. The interventional group will receive direct mud application to the affected shoulder, followed by therapeutic sun exposure for 20 minutes over a continuous period of 2 weeks. Control group will be under the routine usual care for 2 weeks. Baseline assessments includes Visual pain scale analog, range of movements and shoulder pain and disability index score, will be done before intervention of 1^st day for both the groups and post assessments will be done at 14^th day after treatment for both the groups.
4.4 Intervention:
Study group participants will receive a direct mud application at a temperature between 75º -80º F to skin (only if negative, after completing a patch test on dorsum of forearm) on corresponding shoulder region from nape of neck, scapular region, pectoral region and up to middle of arm, (midpoint between shoulder and elbow) and also covers axilla with half inch thickness. Mud used for therapeutical purpose will be collected from 150 cm depth from surface and processed under sunlight for sterilization and powdered finely. The therapeutical mud will be soaked in the tape water overnight and will make it as a paste. After direct mud application the patients will be exposed to sunlight only to corresponding region up to 20 minutes with a head cover and rest of area will be covered with cloth. After treatment participants will be asked to clean the area with cold water. Treatment will be given only between 8 to 10 at forenoon.
4.5 Outcome measures:
Visual Pain Scale Analog: The participants in both the groups will be assessed on day 1 and day 14 using a 10cm Visual Analog Scale where the participants will rate their pain experienced depicted in table.1 (Appendix-1). The scoring of VAS will be calculated by measuring the distance from the left end of the analog scale which corresponds to ‘zero’ and right end which corresponds to ‘ten’, the right end being the highest stage of pain.
Range Of Movements:
A standard goniometer kristeel model-3278 will be used to evaluate the passive range of motion of the shoulder joint in sitting position of patients and the results will be scored and matched against the normal anatomical range of movements was tabulated (Appendix-1) in table 2. The participants in both the groups will be assessed on day 1 and day 14.
Shoulder Pain and Disability Index (SPADI):
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. ^[22] The pain dimension consists of five questions regarding the severity of an individual’s pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use (Appendix-2). Verbal anchors for the pain dimension are ‘no pain at all’ and ‘worst pain imaginable’, and those for the functional activities are ‘no difficulty’ and ‘so difficult it required help’. Validated Tamil version of SPADI is annexed in Appendix-3. The scores from both dimensions are averaged to derive a total score. The participants in both the groups will be assessed using SPADI score on day 1 and day 14.
 5. DATA ANALYSIS:
Data Analysis will be done using statistical package for social sciences 16.0 version