The Present Synopsis Entitled" “A study to evaluate the efficacy of ayurvedic oil massage as an add on therapy to whole system Ayurveda in cases of knee osteoarthritis: a randomized placebo controlled trial.”
AIM OF STUDY To find out the additional benefits of massage therapy with medicated oil in comparison to placebo oil on the patients of Janugata Sandhivata /knee O.A. to receiving the whole system ayurveda intervention.
OBJECTIVES Primary objective To asses if additional benefits of medicated oil massage in comparison to placebo oil along with whole system of ayurveda in its functional outcome.
Secondary objective 1 To develop standard protocol for oil massage in knee osteoarthritis for its maximum efficacy. 2 Evaluating the cost implication. 3 Investigating potential adverse effects. 4 Assessing patient compliance.
PLAN OF STUDY Selection of cases 1. For the purpose of clinical trial, the patients of Janugata Sandhivata / knee O.A will be selected regardless of sex with will be selected randomly from O.P.D, I.P.D and Advanced Arthritis Research Clinic at state ayurvedic college and hospital, Lucknow and also the referred cases which fulfill the criteria. 2. A careful history, physical examination and necessary investigation will be performed as Performa prepared for the present trial.
Type of study Two arm parallel randomized controlled study.
SAMPLE SIZE Minimum 60 patients with approximately 10% of dropouts of Janugata Sandhivata from OPD, IPD and advance arthritis research Centre at SAC & H will be selected & divided into two groups with the help of computer-generated random table. Group A In this group patients will be treated with whole system of ayurveda and massage with active medicated oil (Bala Ashwagandhadi oil)
Group B In this group patients will be treated with whole system of ayurveda and massage with placebo controlled oil (Till tail)
INCLUSION CRITERIA
Patients who will be coming for the treatment of knee O.A in Kayachikitsa OPD and A-ATARC OPD. Patients who will be diagnosed as having knee O.A on the basis of their clinical and radiological features. Age 31 to 60 years. Sex Both Male & Female. Patients who have not taken any ayurvedic treatment earlier. All Socio economic status Patients who will give consent to participate in the study. Radiological evidence of osteoarthritis of the knee joints up to grade3.
EXCLUSION CRITERIA
Patients below 31 years and above 60 years of age. Patients having severe destructive radiological changes. Patients suffering from rheumatoid arthritis, gouty arthritis, psoriatic arthritis, and infective arthritis. Patients who have joint-related diseases other than knee osteoarthritis (OA) Patients with history of trauma, septic arthritis and post traumatic knee pain etc. Patients with osteoarthritis of knee joint of grade 4 and other systematic disorders. Unwilling patients will be excluded.
GROUPING OF PATIENTS
Group A – In this group patients will be treated with whole system of ayurveda and massage with active medicated oil (Bala Ashwagandhadi oil) Group B – In this group patients will be treated with whole system of ayurveda and massage with placebo controlled oil (Till tail) Frequency and Duration
Frequency 5 days in a week.
Duration for 30 min.
Period of study 90 days (5 sitting in a week)
Follow up during trial period- At 30 days interval. Follow up after the trial period- One month following the completion of the three-month trial.
CRITERIA OF ASSESSMENT
OBJECTIVE PARAMETER: 1 Pain intensity in affected joint: visual analogue scale. 2 Change in walking time for a fixed distance (pre &post comparison) 3 Hantisandhi ( range of movement of knee joints pre and post comparison)
SUBJECTIVE PARAMETER: All the signs and symptoms are graded on the basis of their intensity and severity given by patients on complained and confirmed by clinical examination before intervention The clinical improvement during and after the therapy will also be correlated with previous intensity of sign and symptoms.
A. COMMON CLINICAL SYMPTOMS 1. Vatapurnadritisparsa (crepitus) 2. Sandhi Shotha (joint swelling) 3. Prasaran Akunchana pravriti savedana (pain during flexion and extension of joint) 4. Tenderness of knee joints 5. Morning stiffness (
RADIOLOGICAL ASSESSMENT OF KNEE (OA) 1. Joint Space Narrowing 2. Osteophytes Formation 3. Subchondral Bone Sclerosis
Assessment of the result Assessment of the result will be done on the basis of symptomatic relief and the changes in the objective, subjective and radiological parameters before and after the trial. |