A Comparative Clinical Study to Evaluate the Efficacy of Leech Therapy VS NSAIDs (Tab Ibuprofen) and Isometric Exercise in the Management of Sandigatavata with Special Reference Osteoarthritis.

This study is proposed as part of the PhD research/ thesis work of Dr Nidhi

Osteoarthritis is the most common degenerative disorder. Prevalence is high in the old age and the high rate of disability.

• Among those 60year old, about 10% of males and 18% of females are affected with Osteoarthritis. Affected individual, osteoarthritis is the cause of about 2% of years lived with disability.

• Osteoarthritis is an important cause of disability and second most common musculoskeletal problem in the world (30%) after back pain (50%). This is by far the most common type of arthritis.

• It is defined as a condition of synovial joints, characterized by focal loss of articular hyaline cartilage with proliferation of new bone and remodeling of joint contour.

• These all-changes cause pain which restricts the person daily activities and become an insurmountable problem for the person.

• Ayurveda has also elicited the knee joint pain in the term of janu Sandhigatavata which is a vata vyadi. When vatapredominates and gets trapped in the sandhi it produces ruja(i.e pain)

• Osteoarthritis can be correlated with Sandhivata in Ayurveda.  Charaka had described this Vyadhi under Vataj NanatmajVyadhi . Acharya Charaka narrated this condition with symptoms such as inflammation, difficulty while walking and pain while walking, and crepitus present in joint. Contemporary treatment has its own limitation in managing thedisease. In Western science, various treatment options in the Osteoarthritis are present but they do not provide remarkable recovery and cause various side effects. So, there is a need to find effective management in Sandhivata.

• Recent studies also establised effect of leech therapy in Osteoarthritis, and it is trending now in foreign countries.

• Osteoarthritis is a common troubling condition. Yet the disease is not fatal, but its duration & attack makes patient uncomfortable. The incidence of osteoarthritis in India is 12%. It is estimated that approx 4 out of 100 people are affected by Osteoarthritis. Osteoarthritis is the common articular disorder begins asymptomatically in the second & third decades and is common by age 70. year Mostly individual by age 40 have some pathologic change in weight bearing joint, 25% of females & 16% of males have symptomatic osteoarthritis. Western science has its own limitation in managing the disease. This disease is managed by NSAIDs, analgesic, physiotherapy, corticosteroids etc. Above drugs are very costly and cause such as nausea, acidity, vomiting diarrhea etc. These treatments also affect liver and kidneys. Even the surgical managment does not provide complete relief & quite expensive which could not be affordable by every individual. This is a chronic condition that cannot be cured completely. So, a need for search of alternative methods in the management of OA is the need of the hour.

• The saliva of leech contains numerous biological active substances which have anti-inflammatory as well as anesthetic property. 5

• Since Osteoarthritis has become a leading problem in majority of population, the pain caused by it limits the activities of the person and degrades the quality of life of the able and working population. So, a convenient, easy and fast acting method to treat the Osteoarthritic pain is the need of the hour.

• Also, the need of the study is to find out the extent of effectiveness of leech therapy in management of Osteoarthritis

Clinical Study: Leech therapy

Comparative Study will be conducted to assess the efficacy of leech therapy vs NSAIDs ((Tab ibuprofen 600mg) & isometric exercise in the management of janu sandhigata vataW.S.R to Osteoarthritis of knee joint

  CLINICAL STUDY

AIM:

- To compare and evaluate the efficacy of leech therapy vsNSAIDs (Tab ibuprofen 600mg) & isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint.

 OBJECTIVE:

- To evaluate the effect of leech therapy vs NSAIDs (Tab ibuprofen 600mg) and isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint.

- To compare the effect of leech therapy vs NSAIDs (Tab ibuprofen 600mg) and isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint.

        RESEARCH QUESTION:

• Will leech therapy will be effective in the management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint

 HYPOTHESIS:

NULL HYPOTHESIS H0:

Leech therapy   is not effective in management of janusandhigata vata W.S.R to Osteoarthritis   of knee joint.

ALTERNATIVE HYPOTHESIS

• H1 Leech therapy   is equally effective to NSAIDs (Tab ibuprofen 600mg) and isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint.

• H2- Leech therapy is more effective to NSAIDS (Tab ibuprofen 600mg) and isometric exercise in management of janusandhigata vata W.S.R to Osteoarthritis of knee joint.

  CLINICAL STUDY

STUDY DESIGN: It will be a Randomized clinical study.

 SAMPLE SIZE- Total 160 patients will be randomly selected for the study, with ages ranging from 40 years to 70 years, irrespective of gender, religion, occupation, socio- economic status etc.

CLINICAL SOURCE - Patients attending OPD and IPD of Premadhar research institute and hospital, Delhi will be selected for the study. During the course of selection and treatment, a separate case Performa according to the protocol will be used for documentation.

 

• EXPERIMENTAL SOURCE - It is a human clinical trial; no animal experimentation will be done.

 

- SAMPLE SIZE:

- 160 patients

- Two groups of 80 patients each.

- Group A: Leech therapy

- Group B: NSAIDs (Tab ibuprofen 600mg) and isometric exercise

 

- DURATION OF STUDY – 2 month

8 sittings with the gap of 7 days

      Follow up:, 14th ,28th , 42th , 60th day

NSAIDS (Tab ibuprofen 600mg BD) daily 2 month

Isometric exercise daily for 2 month

 ASSESSMENT PARAMETERS FOR OA

 CRITERIA FOR ASSESSMENT

The improvement in the patient will be assessed mainly on the basis of relief in the signs and symptoms of the disease. To assess the effect of therapy objectively, all the signs and symptoms will be given scoring depending upon their severity.

  SUBJECTIVE

1. Vedana (pain)

2. Stiffness (sandhigraha)

 OBJECTIVE

1. Sparsha asahyata (tenderness)

2. Akunchana prasaranajanya vedana

3. Sandhi sphutana (crepitus)

4. Shrama asahyata

5. Shotha (swelling) in joint

  SUBJECTIVE

      1) VEDANA (PAIN) SCORE

– VAS SCALE

0- No pain.

1-3 - Mild.

4-6 - Moderate

7-10- Severe

 STIFFNESS (SANDHIGRAHA)

No stiffness - 0

Mild stiffness - 1

Moderate stiffness - 2

Severe difficulty due to stiffness - 3

Severe stiffness more than 10 minutes – 4

 OBJECTIVE

 SPARSHA ASAHYATA (TENDERNESS)

No tenderness - 0

Patient says tenderness - 1

Winching of face on touch - 2

Does not allow to touch the joint - 3

AKUNCHANA PRASARANAJANYA VEDANA

No pain - 0

Pain without winching of face - 1

Pain with winching of face - 2

Prevent complete flexion - 3

Does not allow passive movement - 4

SANDHI SPHUTANA (CREPITUS)

No crepitus - 0

Palpable crepitus - 1

Audible crepitus - 2

SHRAMA ASAHYATA

Shrama Sahyata - 0

Mild Shrama Ashahyata - 1

Moderate Shrama Asahyta - 2

Severe Shrama Asahyata – 3

SHOTHA (SWELLING) IN JOINT

No swelling - 0

Slight swelling - 1

Moderate swelling - 2

Severe swelling - 3

 SWELLING

    

• Knee joint measurement with measuring tape.

• Middle point of patella, 2 inches above patella and 2 inches below patella will be measured.