Management of avascular necrosis of femoral head in Ayurveda
- Conditions
- Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: ASTHIMAJJAGATAVATA,
- Registration Number
- CTRI/2021/03/031621
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
**Introduction**
AVN or Osteonecrosis of the femoral head is a pathological process that results due to any injury or any occluded blood vessel nourishing the bone tissue which leads to the death of marrow and osteophyte resulting in collapse of necrotic segment of femoral head.In the early stages, there is severe pain from the dying bone. Later this leads to arthritis of the hip, causing stiffness, limitation of movement and disability of the patient in day to day routine life.In India as there is no reliable statistical data available considering the population over a billion approximately 16000 patients get affected with AVN each year. In modern medicine there is no specific treatment available except surgery. (The disease occurrence is more in women than in men with the ratio 1:8.Many surgical procedures like drilling and insertion of bone grafts, modified Whitmen and Colonna reconstructions and insertions of prosthesis are carried out. All these are cost worthy and prognosis is very poor. It is the the most challenging condition of the present era in orthopedics.
In Ayurveda, it can be correlated with *Asthi-majjagata vata* due to similar signs and symptoms of Avascular Necrosis of Neck of Femur. Sign and symptoms of Avascular Necrosis are nearer to *Asthivaha Srotodusti Vikara* (disorders of musculoskeletal origin). Wide range of treatment modalities have been mentioned in Ayurveda particularly by the use of Panchkarma and natural mediciens that are effective in such manifestations.Hence this study is planned,
**OBJECTIVES**
**PRIMARY:** To evaluate the combined effect of *Rukshana,,Patrapinda Swedana* and *Yoga Basti* in the pain management and improvement in range of motion in patients with Avascular necrosis of femoral head.
**SECONDARY:**
1. To improve the Quality of Life in patients with Avascular necrosis of femoral head.
**METHODOLOGY-**
Type of Study Design- Single arm clinical open ended pilot study.
Sample size 15
Sample Collection: - Patients attending thePanchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited.
Duration-84 days
The present dissertation entitled “**A pilot study to evaluate the efficacy of An Ayurveda Protocol in the Management of *AsthimajjaGatavata* W.S.R to Avascular necrosis of femoral headâ€** is a clinical study to know effectiveness of *Ayurvedic* management in AVN.The present work consists of the following 5 chapters:
**1.Introduction**
**2. Review of Literature**
a) Conceptual Study
b) *Ayurvedic* Review
c) Modern Review
d) Drug Review
e) Procedure Review
**3. Materials and method**
1. **Observations and results**
**2.** **Discussion**
**3.** **Conclusion**
INTRODUCTION:This chapter deals with the general description of the disease Avascular necrosis of femoral head & its Ayurveda correlation disorders including incidence-prevalence and importance of Avascular mecrosis of femoral head. The selection of protocol for the present clinical study has been briefly described in this part. Reasoning behind the selection of the therapy also has been discussed . Framework of trial is briefly discussed in this chapter .
OBJECTIVES OF THE STUDY:- The study was planned under following objectives
· **PRIMARY:** To assess the efficacy of Ayurveda protocol based on *AsthiMajjaGataVata* *Chikitsa* in the management of pain and improvement in range of motion in patients of Avascular necrosis of femoral head
· **SECONDARY**: To improve the Quality of Life in patients with Avascular necrosis of femoral head
**REVIEW OF LITERATURE:** Ø It deals with the historical review of *AsthimajjaGatavata*, etymology, definition and physiological aspects of *Asthi* and *Majja Dhatu* with *Gata Vata* concept. Also conceptual study on Nidana, Purvarupa, Rupa, Samprapti, *Sadhyasadhyata, Chikitsa* and *Pathyapathya* of *AsthimajjaGatavata.*
Ø Conceptual study on Avascular Necrosis, Causes, its types, symptoms and treatment.
Ø This chapter also contains the historical review, previous research works, disease review and review of related drugs.
Ø Also the general aspects ofgiven *Panchakarma* proceduressuch as - importance of *Udvartana,* *Swedana, and Basti Karma*, brief historical review of *Udvartana* *Sweadana, and Basti Karma,* classification with some details, indications and contraindications of all the procedures.
Ø Drug review consists of a brief description of the drugs used in the study*.* The drug profile contains the features of the species, family characters, *rasa paṅchaka* and pharmacological actions etc. along with their classical respective therapeutic uses.
**CLINICAL STUDY:**
Materials and methods: This part deals with methodology adopted for this study 1. Inclusion and exclusion criteria 2. Intervention of drug & procedure adminsteratered like *Udvartana, Patra Pinda swedana Yoga Basti,* 3. Assessment of subjective and objective criteria.
**Observations and results:** The observation made on 14 patients regarding demographic incidence of age, sex, diet etc and is presented in the form of tables and chart The results were suitably tabulated and descriptively analysed by statistics. The results thus obtained are presented in the appropriate form. The results of the therapy on Avascular Necrosis are presented with Statistical analysis of both subjective and objective criteria, in the form of table and charts.
**Effect on pain *( Satata Ruk*)**Pain is a primary symptom associated with AVN of femoral head The first procedure *Udvartana* helped to remove the *Srotorodha* caused by *Kapha Dosha* As well as to bring lightness in body by reducing *Amavastha* of *Doshas.* *Patra Pinda Swedana helped to* reduce pain due to its *Ushna* property exactly opposite to *Sheeta guna* of *Vata,* as *Vata* is the main cause of *Shoola* and also due to Anti- inflammatory & analgesic effect of *Nirgundi Patra* used for PPS.
*Swedana* induce local hyperthermia which improves local blood and lymphatic circulation thereby improving local tissue metabolism. It also reduce inflammation by modifying secretion of various inflammatory mediators, reflexing local musculature by physical effect of heat.
It is clear that the given protocol have reduced the Pain ( *Satata* *Ruk*) significantly in the patients of *AsthimajjaGatava*, Pain (*Ruk*) is produced mainly by *Vata Prakopa* and the *Basti*is the best treatment for *Vata*. Site of vata is *Pakvashaya* and *Basti* being administered through the rectal route is the closer route of administration than oral administration .This may be the reason of improvement in Pain. *Basti* has procedural effect also along with the drug effect According to Ayurveda, the ingredients of *Basti* reach up to the small intestine and get absorbed through the gut wall, are distributed in the body and thus exert systemic effects.
.Pain reduction was the primary objective of the study, Here in this study by using of F-test it was measured that pain reduced by every single procedure starting from *Rukshana* to *Shamana.* After completion of follow up, pain gradually reduced by 40.19%.
**Effect on Range of Motion**The present study found that, after 84 days of treatment there was increase in the range of motion of bilateral hip joint of all the patients, flexion 20.8%, extension 28.9%, abduction 31.2%, adduction 40.8%, external rotation 51.8%, internal rotation 50%,respectively of Right hip joint & in left hip joint it was 14.8% flexion, 39% extension 18.6% abduction, 30% adduction, 58% internal rotation, 59.2% external rotation. Decreased Range of motion in AVN patients is due to stiffness cause by *Vata* and *Kapha Prakopa* due to *Sheeta Guna, of vata & Srotorodha* caused by*Kapha Dosha. Udvartana & Patra Pindra swedana helped to remove the stiffness.* *Swedana,* due to its *Stambhaghna* property and *Patra pinda Sweda* due to hyperthermia & massage together, provides muscle relaxant effect and reduces stiffness. *Basti*leads to *Strotoshodhana* resulting into free movement of *Vata* This might be the reason for Improvement in Range of motion
**Effect on Quality of life:**The Secondary objective of the study was to improve the quality of life of patients with ONFH. The mean age of 14 patients in our study was 33.9 yrs (range 18-50 yrs). Most patients affected were in the 3rd and 4th decade of life. The quality of life on patients with ONFH is significantly reduced because of considerable morbidity associated with the disease, especially with bilateral involvement[[2]](file:///W:/bhawna%20thesis/complete%20word%20file.docx#_edn2). There was significant improvement noticed after the treatment in all 9 domains of Sf 36 questainnaire Physical functioning, Role of limitation due to physical functioning, Role of limitation due to emotional functioning, Emotional well being, Fatigue, Social Functioning, Pain, General health, Health Change which is 74.5%, 81.8%, 66.9%, 56.9%, 63.4%, 68.8%, 80.7%, 69.0%, 70.1% respectively. The maximum improvement if found in pain & Role of limitation due to physical functioning. All the procedures given to the patients in the protocol was primarily focusing on the pain management, so it might be the reason that these two parameters were showing more improvement along with rest all other parameters
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Age group between 18- 50 yrs Chronicity-1-5 yrs Gender-both Socioeconomic status-both Diagnostic criteria- Diagnosed cases of Avascular Necrosis of femoral head of grade 1 and 2 with MRI findings.
- Chronicity of more than 5 yrs Severely deformed joints.
- Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women, exposed skin related disease Patients unfit for Pinda svedana, Udwartan and Basti Karma.
- Patients with Grade 3 and Grade 4 AVN Fracture or dislocation induced AVN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in pain. 1st day and 84th day
- Secondary Outcome Measures
Name Time Method Overall improvement in quality of life. 1st day and 84th day
Trial Locations
- Locations (1)
All India Institute of Ayurveda
🇮🇳West, DELHI, India
All India Institute of Ayurveda🇮🇳West, DELHI, IndiaBhawnaPrincipal investigator7988402663solankibhavnadr@gmail.com