Introduction:

Osteoarthritis of knee joint has impact on daily lives of affected individuals, interfering with physical activity, impairing social functioning, and mental wellbeing and reducing productivity at work. The reduction of pain and functional loss are the main objectives of Osteoarthritis of knee joint treatment. In the comprehensive treatment of the disease, both non pharmacologic and pharmaceutical treatments are used. Hence this study is undertaken to understand the effectiveness of 50 millesimal potency in the cases of Knee Osteoarthritis.

Osteoarthritis of Knee: ICD 11 CODE  FA01FA01.Z

At the knee, Osteoarthritis principally targets the patello-femoral and medial tibio-femoral compartments but eventually spreads to affect the whole of the joint. It may be isolated or occur as part of generalised nodal Osteoarthritis. Most patients have bilateral and symmetrical involvement. In men, trauma is often a more important risk factor and may result in unilateral Osteoarthritis. The pain is usually localised to the anterior or medial aspect of the knee and upper tibia. Patello- femoral pain is usually worse going up and down stairs or inclines. Prolonged walking, rising from a chair, getting in or out of a car, or bending to put on shoes and socks may be difficult.

ETIOLOGY:

Knee Osteoarthritis is classified as primary and secondary depending on its cause. Primary Osteoarthritis is the most common subset of the disease and is diagnosed in the absence of a predisposing trauma or disease but is associated with the risk factors. Risk factors for developing Osteoarthritis include age, female gender, obesity, anatomical factors, muscle weakness, and joint injury.

Secondary OA occurs with a preexisting joint abnormality. Predisposing conditions include trauma or injury, congenital joint disorders, inflammatory arthritis, avascular necrosis, infectious arthritis, Paget disease, osteopetrosis, osteochondritis dissecans, metabolic disorders i.e. hemochromatosis, Wilson’s disease.

EPIDEMIOLOGY:

Age Is the Most Powerful Risk Factor for OA in Radiographic Survey of Women more than 45yrs Is Only 2 percent Had OA; Between The Ages of 45 And 64 Years, However, The Prevalence Was 30 percent And for Those less than 65 Yrs It Was 68 percent In Ales Figures Were Similar, But Some What Lower in The Older Age Groups.

Objectives:

     PRIMARY OBJECTIVE

1.      To assess effectiveness of 50 millesimal potency in management of Knee Osteoarthritis

OTHER OBJECTIVE

       1.   To compare pre and post outcome of WOMAC scale of knee     Osteoarthritis

2.      To study clinical presentation of knee osteoarthritis

Methodology

1.                  Type of study design non-controlled experimental study.

2.                  Study setting Patients will be recruited from regular patient pool of the Outdoor Patient Department of the institute.

Study population Clinically Diagnosed patients of Osteoarthritis of knee joint above age 45 to 60yrs

3.                  Duration of the Study 18 months.

4.                  METHODS of selection of study subjects

I.       Inclusion criteria

  Clinically diagnosed patients of unilateral Osteoarthritis of knee joint according to the ACR Clinical classification criteria for knee Osteoarthritis

1.    Patients with radiographic x-ray changes from grade 1 to 3 of Kellgren- Lawrence scale of Osteoarthritis

2.    Patients of all genders.

3.    Patients of age group 45 to 60 years

4.    Patients with well controlled comorbidities.

II. Exclusion criteria:

1.    Patient on any other line of treatment for OA of knee joint

2.    Patient suffering from osteoarthritis other than knee osteoarthritis

3.    Non ambulatory patient.

4.    Patients in low risk according to WOMAC scale low risk WOMAC score more than or equal to 60

5.    Recent Medical/surgical intervention performed on knee

              Patient Withdrawal criteria:

1.    Patients not coming for regular check-up.

2.    Patients who withdraw their consent from the study.

3.    Medical and surgical emergency intervention during study.

5.    Method of selection of comparison or control group: not applicable

6.    Matching criteria: not applicable

7.    OPERATIONAL DEFINITION

ICD 11 CODE FA01-FA01.Z OSTEOARTHRITIS OF KNEE

A.    Osteoarthritis occurring in an otherwise intact knee joint, involving genetically related, age-related or use-related degeneration joint include increasing cartilage loss and osseous transformation such as sclerosis, osteophyte formation and cysts as well as potential inflammatory changes in surrounding soft tissue structures ^[9]. with common clinical features of pain, swelling, stiffness, limited range of motion, crepitus, swelling and changes in gait

LM or 50 MILLESIMAL SCALE

50 MILLESIMAL POTENCIES are Homoeopathic potencies prepared in the 1 is to 50,000 scale as distinct from the Centesimal 1 is to 100 and Decimal 1 is to 10 scales. Dr. Hahnemann prepared, practised with them and advocated in his 6th edition of organon of medicine.

8.      SPECIFICATION OF INSTRUMENTS AND RELATED MESUREMENTS

1.  Standardizing Homoeopathic case taking Performa.

2.   Improvement of the patient will be determined from the WOMAC osteoarthritis index score before and after treatment.

3.  Outcome Assessment Tool

As per International journal of health sciences and research WOMAC is a valid and reliable tool for assessment of hip and knee Osteoarthritis. WOMAC is available in over 65 languages and has been linguistically validated. The Western Ontario and Mc master universities arthritis index WOMAC  is widely used in the evaluation of hip and knee OA. It is a self- administered questionnaire consisting of 24 items divided into 3 subscales. 1. Pain, 2. Stiffness 3. Physical function.

Outcome Assessment Criteria:

1.      Outcome assessment will be based on Clinical parameters.

2.      The outcome assessment will be done on statistically using WOMAC scale before and after treatment of osteoarthritis of knee joint.

                      WOMAC index score categories

                                                              i.      Low risk

                                                             ii.       Moderate risk

                                                           iii.      High risk

The final score for the WOMAC was determined by adding the aggregate score for pain, stiffness and function.  score range from 0 to 96 for the total WOMAC where 0 represent the best health status and 96 the worst possible status. The higher the score the poorer the function therefore an improvement was achieved by reducing the overall score

Sample size is 32 Subjects.

2 Sampling Technique

                 Non probability purposive sampling will be based on

                   inclusion and exclusion criteria

METHODS OF DATA COLLECTION RELEVANT TO OBJECTIVE

1.     Non-probability purposive sampling.

2.     Case record proforma

3.     32 cases will be recorded from college OPD.

Study Instrument/ Data Collection Tools:

1.    Complete homoeopathic case taking Performa.

2.   WOMAC OA index score will be used to assess the severity before and after the treatment.

Appropriate reference book like Homoeopathic Materia Medica, Medicine books, Rheumatology books, Pathology books, different Homoeopathic Journals, research paper will be considered.

3.Appropriate software will be used for repertorisation of case.

5 DATA MANAGEMENT AND ANALYSIS PROCEDURE

3.     Duration of study 18 months.

4.     Duration of each case cases will be observed for a period of 8 months or remission occur whichever required earlier.

5.     Selection of the remedy- Individualized Homoeopathic Medicine will be administered to suitable cases according to totality of symptoms with appropriate potency.

6.     Knee strengthening exercise will be advised to every patient.

Duration

1.      Duration of the follow up of each case: the follow up will be taken at the interval of 15 days, and as when required

2.      Clinical analysis will be done at 0 days ,3 months ,6 months and 8 month

             DATA ANALYSIS PLAN AND METHOD

STATISTICAL TECHNIQUE

Data collected will be compiled on to a MS Office excel

worksheet & will be subjected to statistical analysis using an appropriate package like SPSS Software.

Descriptive statistics like frequency & percentage  of categorical data, mean & Standard deviation of numerical data in each time interval will be depicted.

Normality of numerical data will be checked using Shapiro - Wilk

test or Kolmogorov-Smirnov test.

Depending on the normality of data, statistical tests will be determined.

Intra group comparisons (before and after) for a numerical continuous data following a normal distribution will be done using paired T test for 2 observation else a non-parametric substitute like Wilcoxon signed rank test for 2 observations will be used.

Frequency  & percentage of various categories in each time interval will be compared using Paired T test.